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BOCA RATON, Fla., June 08, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ: AZRX), (“AzurRx” or the “Company”), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced today that James Sapirstein, Chief Executive Officer of AzurRx, will present at the 2021 BIO Digital. The virtual conference is taking place June 10-11 and June 14-18, 2021.

Details of the event are as follows:

Event: 2021 BIO Digital
Date:  June 10-11 and June 14-18, 2021
Registration: https://www.bio.org/events/bio-digital/registration

In a prerecorded presentation, Mr. Sapirstein will provide an overview of AzurRx’s business and clinical development programs and discuss anticipated 2021 and early 2022 milestones. The presentation will be available on demand to registered conference attendees beginning at 9 a.m. ET on June 10, 2021.

Additionally, Mr. Sapirstein and members of the AzurRx management team will be participating in virtual one-on-one meetings with registered investors and pharmaceutical company executives.

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of three gut-restricted GI assets. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis, currently in two Phase 2 clinical trials. AzurRx is launching two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor; FW-1022, for COVID-19 gastrointestinal infections and FW-420, for grade 1 Immune Checkpoint Inhibitor-Associated Colitis and diarrhea in oncology patients. The Company is headquartered in Boca Raton, Florida with clinical operations in Hayward, California. For more information visit www.azurrx.com.

Forward-Looking Statement
This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; the size of the potential markets for the Company’s drug candidates and its ability to service those markets; and the Company’s current and future capital requirements and its ability to raise additional funds to satisfy its capital needs. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:

AzurRx BioPharma, Inc.
777 Yamato Road
Suite 502
Boca Raton, Florida 33431
Phone: (561) 589-7020
This email address is being protected from spambots. You need JavaScript enabled to view it.

Media contact:

Tiberend Strategic Advisors, Inc.
Johanna Bennett/Ingrid Mezo
(212) 375-2665/(646) 604-5150
This email address is being protected from spambots. You need JavaScript enabled to view it./This email address is being protected from spambots. You need JavaScript enabled to view it.


“RESERVOIR” trial to evaluate niclosamide’s ability to target SARS-CoV-2 in the GI tract

Topline trial data expected in Q1 2022

BOCA RATON, Fla., June 07, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ: AZRX), (“AzurRx” or the “Company”), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced today the administration of the first dose of FW-1022 to a volunteer in the ongoing Phase 2 RESERVOIR clinical trial. FW-1022 is a proprietary oral tablet formulation of micronized niclosamide developed for the treatment of COVID-19-related GI infections. Topline results from the trial are expected in the first quarter of 2022.

“Dosing the first patient in the RESERVOIR clinical trial marks a significant milestone for AzurRx and the development of niclosamide as a potential treatment for COVID-19-related GI infections,” said James Sapirstein, Chief Executive Officer of AzurRx BioPharma. “There are currently no approved treatments available for COVID-19-related GI infections. If our development program is successful, we believe that FW-1022 could help prevent reinfection and the spread of COVID-19, as well as treat certain potentially severe complications that many people believe to be caused by the ability of SARS-CoV-2 to hide in reservoirs within the GI tract. We believe our micronized oral niclosamide therapy has the potential to target the virus directly in the gut and play an important role in treating COVID-19 patients experiencing the damaging aftereffects of COVID-19-related GI infection.”

The RESERVOIR clinical trial is designed as a two-part, two-arm, placebo-controlled Phase 2 study. The trial’s primary objectives are to confirm the safety of FW-1022 in the treatment of patients with COVID-19-related GI infections and to evaluate its efficacy in clearing SARS-CoV-2 from the GI tract. The primary efficacy measure of the RESERVOIR trial is the rate of fecal SARS-CoV-2 clearance (rectal swab or stool sample) assessed by RT-PCR, comparing the niclosamide arm to the placebo arm for up to six months. These long-term observation data could indicate that niclosamide treatment has the potential to improve “long haul” COVID-19 symptoms.

“As a practicing clinician, I have treated hundreds of COVID-19 patients with many reporting GI issues resulting from the virus, including severe diarrhea, vomiting and abdominal pain. However, COVID-related GI infection remains an underappreciated and often untreated aspect of the disease despite its prevalence and adverse impact on the patient,” said Salma Saiger, M.D., of SMS Clinical Research, LLC and an investigator with the RESERVOIR clinical trial. “Given this, there is a pressing need to develop therapeutics to directly treat SARS-CoV-2 that may be hiding in the GI tract. Preclinical evidence suggests that micronized niclosamide could provide such an opportunity, and I am excited to be part of the investigative team researching the drug in the Phase 2 RESERVOIR trial.”

“Evidence continues to build in support of niclosamide as a potential COVID-19 therapy, including research from the Institut Pasteur Korea suggesting that niclosamide could be 40 times more potent than remdesivir in inhibiting SARS-CoV-2,” said James Pennington, M.D., Chief Medical Officer of AzurRx. “We believe FW-1022, our micronized formulation of niclosamide, is ideally equipped to clear SARS-CoV-2 hiding in the gut due to its proven safety profile and known effectiveness in treating other GI ailments, and its ability to remain in the gut for long periods of time. We look forward to reporting topline data from RESERVOIR in early 2022.”

More information about this clinical trial is available at ClinicalTrials.gov.

About COVID-19 Gastrointestinal Infections

Gastrointestinal infection symptoms (severe diarrhea, vomiting and abdominal pain) have been reported in approximately 18% of COVID-19 cases.1 Of the 33 million individuals who are reported to have contracted COVID-19 in the U.S.,2 this would translate into 6 million patients having GI infection. Of the 165 million cases globally,3 it would translate into almost 30 million patients. Furthermore, approximately 10% of patients who were infected with COVID have persistent symptoms months after their initial diagnosis.3 Approximately 86% of these COVID “long haulers” are reported to have GI infection symptoms, with 60% continuing to have diarrhea months after their initial infection.4

There is some evidence to support the view that the GI tract is a possible reservoir for recurrence and fecal spread of the COVID-19 virus as ACE-2, the entry receptor for COVID-19, is highly expressed on GI cells. There currently is no targeted treatment for COVID GI infections.

About Niclosamide

Niclosamide is a prescription small molecule drug listed as an essential medicine by the World Health Organization (WHO). Niclosamide has been safely used on millions of patients for other clinical indications.  In the U.S., niclosamide was approved by the U.S. Food and Drug Administration (FDA) in 1982 for the treatment of intestinal tapeworm infections. In addition to its antihelminthic activity, niclosamide has demonstrated anti-inflammatory and anti-viral properties.

There remains an urgent need to develop new medicines that can be manufactured at large scale quickly to treat COVID-19. Niclosamide was recently identified by the Institut Pasteur Korea as a potent inhibitor of SARS-CoV-2, the virus causing COVID-19, with potency 40X greater than remdesivir.5 Additionally, emerging evidence confirms the severe GI-related complications of COVID and potential fecal spread of the virus. The Company’s clinical trials may establish that patients treated with an oral and non-systemic niclosamide formulation that delivers high local GI concentrations have decreased viral load and GI-associated symptoms of COVID. Importantly, the manufacturing process for niclosamide can be scaled up to supply large populations quickly.

FW-1022

FW-1022 is a niclosamide based small molecule which the Company’s clinical trials may establish has anti-viral activity that is effective for the treatment of SARS-CoV-2 (COVID-19) gastrointestinal infections. FW-1022 is anticipated to be supplied as an oral immediate release tablet. The formulation to be used has been milled (micronized) to allow superior dissolution in the gut fluids. This in turn may allow local niclosamide concentrations to reach anti-viral levels. Thus, FW-1022 has the potential to benefit COVID patients by decreasing viral load in the GI tract, treating infection symptoms and preventing transmission of the virus through fecal spread.

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of three gut-restricted GI assets. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis, currently in two Phase 2 clinical trials. AzurRx is launching two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor: FW-1022 for COVID-19 gastrointestinal infections, and FW-420 for grade 1 Immune Checkpoint Inhibitor-Associated Colitis and diarrhea in oncology patients. The Company is headquartered in Boca Raton, Florida with clinical operations in Hayward, California. For more information visit www.azurrx.com.

Forward-Looking Statement
This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including the ability of the Company to finance its operations; whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations, including potential delays in clinical trial recruitment and participation. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:

AzurRx BioPharma, Inc.
777 Yamato Road
Suite 502
Boca Raton, Florida 33431
Phone: (561) 589-7020
This email address is being protected from spambots. You need JavaScript enabled to view it.

Media contact:

Tiberend Strategic Advisors, Inc.
Johanna Bennett/Ingrid Mezo
(212) 375-2665/(646) 604-5150
This email address is being protected from spambots. You need JavaScript enabled to view it./This email address is being protected from spambots. You need JavaScript enabled to view it.

References:

¹ Gut Journal: Vol 69, Issue 6: 2020; Gut Journal: Vol 69, Issue 6: 2020; JAMA Network: Vol 3, Issue 6: 2020; Lancet Gastroenterol Hepatol: Vol 5, Issue 5: 2020; Cheung Gastroenterology: Vol. 159, Issue 1: 2020
2 New York Times. (5/20/21) https://www.nytimes.com/interactive/2020/world/coronavirus-maps.html
3 Rubin, R. “As their numbers grow, COVID-19 “Long Haulers” Stump Experts”. https://jamanetwork.com/journals/jama/fullarticle/2771111 September 23, 2020.
4 Davis, et al. “Characterizing Long Covid in an International Cohort: 7 Months of Symptoms and their Impact”. https://www.medrxiv.org/content/10.1101/2020.12.24.20248802v2.full.pdf
5 Jeon S, Ko M, Lee J, Choi I, Byun SY, Park S, Shum D, Kim S. 2020. Identification of antiviral drug candidates against SARS-CoV-2 from FDA-approved drugs. Antimicrob Agents Chemother 64:e00819-20. https://doi.org/10.1128/AAC.00819-20.


DELRAY BEACH, Fla., May 19, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ: AZRX), (“AzurRx” or the “Company”), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that James Sapirstein, AzurRx President, CEO and Chairman, will present at the Rocky Mountain Microcap Conference on May 26, 2021.

During his live virtual presentation on Wednesday, May 26, 2021 at 12:28 p.m. EDT, Mr. Sapirstein will provide an overview of AzurRx’s business and clinical development programs and discuss anticipated 2021 and early 2022 milestones. Additionally, Mr. Sapirstein and members of the AzurRx management team will be participating in virtual one-on-one meetings with registered investors.

Details of the presentation are as follows:

 Event: Rocky Mountain Microcap Conference
 Date:  Wednesday, May 26, 2021
 Time: 12:28 p.m. EDT
 Registration to View Virtual 
Presentation:
 https://rockymountain.mysequire.com/

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of three gut-restricted GI assets. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis, currently in two Phase 2 clinical trials. AzurRx is launching two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor, FW-420, for grade 1 Immune Checkpoint Inhibitor Colitis and diarrhea in oncology patients and FW-1022, for COVID-19 gastrointestinal infections. The Company is headquartered in Delray Beach, Florida with clinical operations in Hayward, California. For more information, visit www.azurrx.com.

Forward-Looking Statement
This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; the size of the potential markets for the Company’s drug candidates and its ability to service those markets; and the Company’s current and future capital requirements and its ability to raise additional funds to satisfy its capital needs. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:
AzurRx BioPharma, Inc.
1615 South Congress Avenue
Suite 103
Delray Beach, Florida 33445
Phone: (646) 699-7855
This email address is being protected from spambots. You need JavaScript enabled to view it.

Media contact:
Tiberend Strategic Advisors, Inc.
Johanna Bennett/Ingrid Mezo
(212) 375-2665/(646) 604-5150
This email address is being protected from spambots. You need JavaScript enabled to view it. / This email address is being protected from spambots. You need JavaScript enabled to view it.


NEW YORK, May 14, 2021 (GLOBE NEWSWIRE) -- FMW Media Corp. announces that its “New To The Street” business TV show will feature AzurRx BioPharma, Inc. (NASDAQ: AZRX) in a 3-part TV series featured across its entire syndicated linear television platform.

The televised interviews of with Mr. James Sapirstein, Chairman & CEO of AzurRx BioPharma, Inc., along with the “New To The Street’s” host Jane King, are to be broadcasted on syndicated Newsmax Television, Sunday mornings 10-11AM ET. Also, the TV interview is being broadcasted on FOX Business Network on Monday, May 17, 2021 at 10:30 PM PT. Future filmed tapes and broadcasting on KRON-TVRNNBloomberg TV and other stations “To Be Announced.”

Mr. James Sapirstein, Chairman & CEO of AzurRx BioPharma (NASDAQ: AZRX) talks to the “New To The Street’s” TV audience about AZRX’s biopharmaceutical products and therapies. He gives a comprehensive overview in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. And, provides insight on its FDA Phase 2 clinical trials on its lead therapeutic candidate MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis.  

James Sapirstein, CEO, AZRX states, “I am excited to be a guest on the ‘New To The Street’ TV program. The show has had a tremendous track record; I am happy to join the ranks. I look forward to educating viewers about AzurRx BioPharma - about our business, our biopharmaceutical products and therapies, and our future to grow the Company.”

Vincent Caruso, CEO FMW Media Corp. and the Creator / Producer of “New To The Street” TV states, “I am excited to have AzurRx BioPharma, Inc. on the show for a 3-part series. AZRX’s biopharmaceutical products and therapies make them a great guest Company explaining their business to our syndicated TV audiences.”

About AzurRx BioPharma (NASDAQ: AZRX):

AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of three gut-restricted GI clinical programs. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis, currently in two Phase 2 clinical trials. AzurRx is launching two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor; FW-420, for grade 1 Immune Checkpoint Inhibitor-associated colitis and diarrhea in oncology patients and FW-1022, for COVID-19 gastrointestinal infections – https://azurrx.com.

About FMW Media:
FMW Media operates one of the longest-running U.S and international sponsored and syndicated Nielsen Rated programming T.V. brands "New to the Street," and its blockchain show "Exploring The Block." Since 2009, these brands run biographical interview segment shows across major U.S. television networks. The TV platforms reach over 540 million homes both in the US and international markets. FMW recently added Newsmax to its broadcasting platform with its first show broadcasted Sunday, December 27th. The NEWSMAX New To The Street show is syndicated on Sundays at 10 AM EST. FMW is also one of the nation's largest buyers of linear television long and short form - https://www.newsmaxtv.com/Shows/New-to-the-Street and https://www.newtothestreet.com/

Forward-Looking Statements Disclaimer:
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by the following words: "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "should," "will," "would," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are not a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by, which such performance or results achieved. This press release should be considered in light of all filings of the Company contained in the Edgar Archives of the Securities and Exchange Commission at www.sec.gov.

FMW Media Contact:
Bryan Johnson
+1 (631) 766-7462
This email address is being protected from spambots. You need JavaScript enabled to view it.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/6101c2d5-4b3e-4579-81a6-180539dfbce1

Data from first 18 patients indicate MS1819 and PERT combination led to clinically meaningful improvements in primary efficacy endpoint

Full top-line data expected in Q2 2021

DELRAY BEACH, Fla., May 13, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ: AZRX), (“AzurRx” or the “Company”), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced positive interim data from the first 18 out of 20 patients in its Phase 2 trial evaluating MS1819 in combination with the current standard of care, porcine-derived pancreatic enzyme replacement therapy (PERT), for the treatment of severe exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF).

The interim topline data revealed that the combination therapy led to clinically meaningful improvements in the primary efficacy endpoint, the Coefficient of Fat Absorption (CFA), with an average gain of 5.9 points from baseline. According to the clinical literature, a five-point improvement in CFA is considered clinically significant.1

“We are encouraged by the promising interim data from the first 18 patients in our Phase 2 clinical trial, evaluating MS1819 in combination with PERT for the treatment of EPI in cystic fibrosis patients,” said James Sapirstein, President, CEO and Chairman of AzurRx. “Based on the clinical results to date, we believe that the combination therapy has significant potential to help the 25-30% of refractory cystic fibrosis patients with severe EPI who are unable to achieve adequate nutrition using PERT alone. Adding MS1819 to the treatment regimen appears to enable these patients to meet their nutritional needs, reduce the debilitating symptoms of EPI, and improve their overall quality of life, with an acceptable safety profile. We expect to report full topline results from all 20 patients enrolled in the trial in the second quarter of 2021.”

Dr. Bulent Karadag, the principal investigator in the trial from the Marmara University Faculty School of Medicine in Istanbul, Turkey, stated, "Many of my patients suffer from severe EPI and a number are not adequately controlled. They frequently reported that they felt better after taking MS1819 over the course of the six-week trial."

Dr. James Pennington, Chief Medical Officer of AzurRx, commented, “The overarching goal of our MS1819 program is to provide a safe and effective therapy to control EPI, a debilitating gastrointestinal condition common to patients with cystic fibrosis that can result in numerous, life-altering complications, including malnutrition. Based on the clinical evidence from the combination trial to-date, we have been able to improve the nutritional status of the severe EPI patients who need the most help. It turns out that the patients with the lowest baseline CFAs had the largest improvements in CFA in the study. It is also very encouraging to note that all the patients responded well and that many reported that they felt better overall when MS1819 was added to their daily dose of PERT.”

The Phase 2 combination clinical trial is a multi-center study designed to investigate the safety, tolerability and efficacy of escalating doses of MS1819, in conjunction with a stable dose of PERT, in order to increase the patient’s coefficient of fat absorption (CFA) levels and relieve abdominal symptoms. The study enrolled 20 patients, 12 years of age or older, with severe EPI who were treated escalating doses of MS1819 (700mg, 1200mg, and 2240mg) once daily for 15 days per dosing level, in addition to their standard PERT dose. Baseline CFA is established by measuring CFA levels while on standard of care therapy only, before beginning combination therapy. Trial eligibility requires a CFA of less than 80%. The primary efficacy endpoint of the trial is improvement in CFA; secondary endpoints of the study are improvements in the stool weight, stool consistency, number of bowel movements, the incidence of steatorrhea, and increase of body weight.

Additional information about this clinical trial can be found at: https://clinicaltrials.gov/ct2/show/NCT04302662

About the MS1819 Combination Therapy Study
The digestive standard of care for both CF and chronic pancreatitis (CP) patients with EPI are commercially-available PERTs. Ideally, a stable daily dose of PERT will enable CF patients to eat a normal to high-fat diet and minimize unpleasant gastrointestinal symptoms. In practice, however, a substantial number of CF patients do not achieve normal absorption of fat with PERTs1,2. Achieving an optimal nutritional status, including normal fat absorption levels, in CF patients is important for maintaining better pulmonary function, physical performance and prolonging survival. Furthermore, a decline of body mass index around the age of 18 years predicts a substantial drop in lung function3,4.

A combination therapy of PERT and MS1819 has the potential to: (i) correct macronutrient and micronutrient maldigestion; (ii) eliminate abdominal symptoms attributable to maldigestion; and (iii) sustain optimal nutritional status on a normal diet in CF patients with severe EPI. Planned enrollment is expected to include approximately 24 CF patients with severe EPI, with study completion anticipated in 1Q 2021.

About MS1819
MS1819 is a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis. MS1819, supplied as an oral, non-systemic, biologic capsule, is derived from the Yarrowia lipolytica yeast lipase and breaks up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients. Unlike the standard of care, the MS1819 synthetic lipase does not contain any animal products.

About Exocrine Pancreatic Insufficiency
EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in a patient’s inability to digest food properly, or maldigestion. The deficiency in this enzyme can be responsible for greasy diarrhea, fecal urge and weight loss.

There are more than 30,000 patients in the U.S. with EPI caused by cystic fibrosis according to the Cystic Fibrosis Foundation and approximately 90,000 patients in the U.S with EPI caused by chronic pancreatitis according to the National Pancreas Foundation. Patients are currently treated with porcine pancreatic enzyme replacement pills.

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of three gut-restricted GI assets. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis, currently in two Phase 2 clinical trials.  AzurRx is launching two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor, FW-420, for grade 1 Immune Checkpoint Inhibitor Colitis and diarrhea in oncology patients and FW-1022, for COVID-19 gastrointestinal infections. The Company is headquartered in Delray Beach, Florida with clinical operations in Hayward, California. For more information, visit www.azurrx.com.

Forward-Looking Statement
This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; the size of the potential markets for the Company’s drug candidates and its ability to service those markets; and the Company’s current and future capital requirements and its ability to raise additional funds to satisfy its capital needs. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:
AzurRx BioPharma, Inc.
1615 South Congress Avenue
Suite 103
Delray Beach, Florida 33445
Phone: (646) 699-7855
This email address is being protected from spambots. You need JavaScript enabled to view it.

Media contact:
Tiberend Strategic Advisors, Inc.
Johanna Bennett/Ingrid Mezo
(212) 375-2665/(646) 604-5150
This email address is being protected from spambots. You need JavaScript enabled to view it./This email address is being protected from spambots. You need JavaScript enabled to view it.

1 Brady, M.S et al, 2006, Journal of American Dietetic Association, 2006, 1181-1185.
2 Freedman, S.D., Am. J. Manag. Care, 2017; 23: S2220-S228
3 Littlewood, J. et al, 2006, Pediatric Pulmonology, 41:35-49
4 Engelen, M. et al, 2014, Curr. Opin. Clin. Nutr. Metab. Care; 17(6):515-520
5 Vandenbranden, S.L. et al, 2012, Pediatric Pulmonology, 2012; 47(2): 135-143


DELRAY BEACH, Fla., May 12, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ: AZRX), (“AzurRx” or the “Company”), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that AzurRx SAS, its wholly-owned subsidiary in France, has received approximately 459,000 Euros ($550,000 U.S.) in non-dilutive funding in research tax credits from the French government for its 2020 CIR (French Research Tax Credit).

James Sapirstein, Chief Executive Officer of AzurRx commented, “We are very thankful for the French government’s continued support and pleased to receive the 2020 CIR. These funds have enabled us to successfully run the European arms of our two Phase 2 MS1819 clinical trials - despite the challenges posed by the COVID epidemic. We plan to re-invest the CIR funds in our ongoing, European-based clinical trials which are anticipated to complete in 2021.”

The French R&D tax credit initiative (“Crédit d’Impôt Recherche”, or CIR) gives eligible research-based French companies, which are subject to corporate tax in France, the ability to claim tax relief of up to 30% on costs incurred in R&D activities in France and the European Union.

Previously received CIR funds have been by AzurRx to support its MS1819 clinical program for the treatment of exocrine pancreatic insufficiency (EPI) in cystic fibrosis (CF) patients in Europe, including both the ongoing Phase 2 Combination trial, evaluating MS1819 in combination with PERT (porcine-derived pancreatic enzyme replacement therapy) in CF patients with severe EPI, and the Phase 2b OPTION 2 MS1819 monotherapy clinical trial.

About CIR
The Research Tax Credit (CIR) is a tax incentive provided by the French Government to encourage the growth of businesses' competitiveness by favoring research and development (R&D) and innovative activities. It is particularly adapted to the needs of small and medium-sized enterprises.

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of three gut-restricted GI assets. The lead therapeutic drug candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis. AzurRx is also advancing two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor; FW-1022, for COVID-19 GI infections and FW-420, for Grade 1 Immune Checkpoint Inhibitor-Associated Colitis and diarrhea in oncology patients. The Company is headquartered in Delray Beach, Florida, with clinical operations in Hayward, California. For more information visit www.azurrx.com.

Forward-Looking Statement
This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; the size of the potential markets for the Company’s drug candidates and its ability to service those markets; and the Company’s current and future capital requirements and its ability to raise additional funds to satisfy its capital needs. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:
AzurRx BioPharma, Inc.
1615 South Congress Avenue
Suite 103
Delray Beach, Florida 33445
Phone: (646) 699-7855
This email address is being protected from spambots. You need JavaScript enabled to view it.

Media contact:
Tiberend Strategic Advisors, Inc.
Johanna Bennett/Ingrid Mezo
(212) 375-2665/(646) 604-5150
This email address is being protected from spambots. You need JavaScript enabled to view it./This email address is being protected from spambots. You need JavaScript enabled to view it.


DELRAY BEACH, Fla., May 11, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ: AZRX), (“AzurRx” or the “Company”), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that James Sapirstein, AzurRx President, CEO and Chairman, will present at Investor Summit Group’s Q2 Virtual Investor Summit taking place May 17-18, 2021.

During his live virtual presentation on Monday, May 17, 2021 at 9:30 a.m. EDT, Mr. Sapirstein will provide an overview of AzurRx’s business and clinical development programs and discuss anticipated 2021 and early 2022 milestones. Additionally, Mr. Sapirstein and members of the AzurRx management team will be participating in virtual one-on-one meetings with registered investors.

Details of the presentation are as follows:

Event:Investor Summit Group’s Q2 Virtual Summit
Date: Monday, May 17, 2021
Time:9:30 a.m., EDT
Registration:
Presentation:
https://investorsummitgroup.com/register/
https://zoom.us/webinar/register/WN_GvA0wYzFTm6gUl0u2xZSqg

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of three gut-restricted GI assets. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis, currently in two Phase 2 clinical trials. AzurRx is launching two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor, FW-420, for grade 1 Immune Checkpoint Inhibitor Colitis and diarrhea in oncology patients and FW-1022, for COVID-19 gastrointestinal infections. The Company is headquartered in Delray Beach, Florida with clinical operations in Hayward, California. For more information, visit www.azurrx.com.

Forward-Looking Statement
This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including potential delays in clinical trial recruitment and participation. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:
AzurRx BioPharma, Inc.
1615 South Congress Avenue
Suite 103
Delray Beach, Florida 33445
Phone: (646) 699-7855
This email address is being protected from spambots. You need JavaScript enabled to view it.

Media contact:
Tiberend Strategic Advisors, Inc.
Johanna Bennett/Ingrid Mezo
(212) 375-2665/(646) 604-5150
This email address is being protected from spambots. You need JavaScript enabled to view it./This email address is being protected from spambots. You need JavaScript enabled to view it.


DELRAY BEACH, Fla., May 11, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ: AZRX), (“AzurRx” or the “Company”), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that the Company will make a virtual presentation at the Emerging Growth Conference taking place on Wednesday, May 12th, 2021.

During their live virtual presentation at 10:30 a.m. EDT, members of AzurRx’s management team will provide an overview of AzurRx’s business and clinical development programs and discuss anticipated 2021 and early 2022 milestones.

Details of the presentation are as follows:

Event: Emerging Growth Conference
Date:  Wednesday, May 12, 2021
Time: 10:30 a.m., Eastern Time
Registration:

 https://goto.webcasts.com/starthere.jsp?ei=1460582&tp_key=3d7db8edcf&sti=azrx 

If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available on EmergingGrowth.com and we will also release a link to that after the event.

About the Emerging Growth Conference
The Emerging Growth conference is an effective way for public companies to present and communicate their new products, services and other major announcements to the investment community from the convenience of their office, in a time efficient manner.

The Conference focus and coverage includes companies in a wide range of growth sectors, with strong management teams, innovative products & services, focused strategy, execution, and the overall potential for long term growth. Its audience includes potentially tens of thousands of Individual and Institutional investors, as well as Investment advisors and analysts. All sessions will be conducted through video webcasts and will take place in the Eastern time zone.

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of three gut-restricted GI assets. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis, currently in two Phase 2 clinical trials. AzurRx is launching two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor, FW-420, for grade 1 Immune Checkpoint Inhibitor Colitis and diarrhea in oncology patients and FW-1022, for COVID-19 gastrointestinal infections. The Company is headquartered in Delray Beach, Florida with clinical operations in Hayward, California. For more information, visit www.azurrx.com.

Forward-Looking Statement
This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including potential delays in clinical trial recruitment and participation. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:
AzurRx BioPharma, Inc.
1615 South Congress Avenue
Suite 103
Delray Beach, Florida 33445
Phone: (646) 699-7855
This email address is being protected from spambots. You need JavaScript enabled to view it.

Media contact:
Tiberend Strategic Advisors, Inc.
Johanna Bennett/Ingrid Mezo
(212) 375-2665/(646) 604-5150
This email address is being protected from spambots. You need JavaScript enabled to view it./This email address is being protected from spambots. You need JavaScript enabled to view it.

 


DELRAY BEACH, Fla., April 15, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ: AZRX), (“AzurRx” or the “Company”), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today issued a letter to its shareholders from James Sapirstein, President, Chief Executive Officer and Chairman, highlighting the company’s corporate and clinical achievements during the first quarter of 2021 and recent weeks.

The full text of the letter, which has also been posted to the Company's website, is as follows:

Dear AzurRx Shareholders,

It was just a few months ago that AzurRx began 2021 with news of a transformative in-licensing deal with First Wave Bio that added a new asset, proprietary formulations of micronized niclosamide, with two new therapeutic indications, for COVID-19 GI infections and immune checkpoint inhibitor-associated colitis (ICI-AC), to our clinical-stage pipeline.

I am pleased to report that we are on track to launch both niclosamide programs in the clinic. In April 2021, we announced the initiation of RESERVOIR, our Phase 2 (Proof of Principle) clinical trial of niclosamide for the treatment of COVID-19-related gastrointestinal infections, and that we engaged PPD, Inc., a leading clinical research organization (CRO) to manage the Phase 1b/2a ICI-AC trial that we plan to initiate in Q2 2021.

Additionally, we continued the development of MS1819 as a potential treatment for exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF). We reported topline data from our Phase 2b OPTION 2 monotherapy data at the end of Q1 2021 and expect to report topline data from our Phase 2 combination therapy trial using MS1819 in combination with the current standard of care, pancreatic enzyme replacement therapy (PERT), in Q2 2021. We continue to believe that MS1819 has the potential to supplant PERT as the gold standard treatment for EPI in patients with CF and chronic pancreatitis (CP).

These events are just the tip of the iceberg. AzurRx remains focused on its mission to develop valuable therapies with significant market opportunities into the GI space, and, as it does so, generate value for shareholders.

AzurRx – Focused on Targeted, Non-Systemic GI Therapeutics

Our most advanced clinical asset, MS1819, is a recombinant lipase enzyme designed to treat EPI in patients with CF and CP. EPI is a common complication of CF and CP caused by an enzyme deficiency that leaves patients unable to properly digest food and absorb nutrients. Our goal is to provide a safe and effective therapy to control EPI and improve upon PERT, which is primarily derived from pig pancreases and requires patients to take upwards of 40 capsules per day to control symptoms. The target market for EPI is substantial, at more than $1.4 billion in the U.S. and over $2 billion globally in 2019. We continue to believe that MS1819 has strong potential with the ability to attract partnership opportunities and licensing interest from Big Pharma.

With micronized niclosamide, we are exploring two separate indications -- COVID-19-related GI infections and immune checkpoint inhibitor-associated colitis in advanced stage cancer patients. We believe both indications are synergistic and a good fit for AzurRx, which also have high unmet need and sizable market opportunities.

Niclosamide – Launching Two Clinical Trials in 1H 2021

FW-1022: Phase 2 COVID-GI Infection Trial
In early April, we initiated our Phase 2 RESERVOIR trial, a two-part, two-arm, placebo-controlled study examining the safety and efficacy of FW-1022, an oral micronized niclosamide tablet, for COVID-19-related GI infections.

COVID-19 continues to impact hundreds of thousands of people worldwide every day in addition to the millions who have already been infected. For many, the after-effects of COVID-19 can be as bad as the disease itself, and this includes a growing number who experience “long haul” GI complications due to what many believe is the ability of the SARS-CoV-2 virus to hide in reservoirs within the GI tract. Gastrointestinal infection symptoms (severe diarrhea, vomiting and abdominal pain) have been reported in ~18% of COVID-19 cases, with viral RNA positive stool samples being reported in ~48% of all COVID-19 patients in a recent study.1 Furthermore, approximately 10%2 of patients who were infected with COVID have persistent symptoms months after their initial diagnosis. Approximately 86% of these COVID “long haulers” are reported to have GI infection symptoms, with 60% having diarrhea months after their initial infection.3

It is important to understand that despite all the progress made with vaccines that they are not going to end the COVID pandemic – the disease is becoming endemic. Vaccines have given us hope, but the emergence of new and more transmissible SARS-CoV-2 variants which keep cropping up all over the world, suggest that COVID-19 may remain with us for several years to come. Moreover, we will not be able to vaccinate everyone we need to. There remains a strong need to find therapeutics that can help most of the world’s population deal with the effects of COVID-19 infections and we believe that our niclosamide therapeutic has a strong and lasting role to play in treating patients.

There is a growing body of evidence supporting the potential of niclosamide as a COVID-19 therapy. Niclosamide was identified by the Institut Pasteur Korea as a potent inhibitor of SARS-CoV-2, the virus causing COVID-19, with potency 40X greater than remdesivir.A recent study published in the journal Nature found that niclosamide could prevent long-term lung damage in COVID-19 patients.5 We believe that our micronized oral niclosamide therapy has the potential to target SARS-CoV-2 directly in the gut and to become an important addition to the numerous therapeutics that may unfortunately be required by many who contract COVID-19. There currently is no targeted treatment for COVID GI infections and we are optimistic that we will be the first therapy to market in this indication.

Patient enrollment is underway for the RESERVOIR trial, with topline data anticipated in the first quarter of 2022.

FW-420: Phase 1b/2a Immune Checkpoint Colitis Trial
Meanwhile, we are preparing to launch a second clinical trial soon. This is a Phase 1b/2a study evaluating oral micronized niclosamide tablets, known as FW-420, for Grade 1 Immune Checkpoint Inhibitor-Associated Colitis (ICI-AC). Immune checkpoint inhibitors have been a major advance in cancer therapeutics, but the drugs can induce a serious inflammation of the bowels, which if left unchecked, can be life-threatening and force patients to halt treatment. There currently is no approved treatment for Grade 1 colitis. Our goal is to develop FW-420 as a therapeutic that halts ICI-AC from progressing and enables patients to continue their immunotherapy treatment regimen uninterrupted.

We recently announced that we engaged PPD, a leading CRO, to manage the clinical trial and anticipate initiation of the study in Q2 2021.

We believe that both niclosamide programs can be completed relatively quickly and have the potential for accelerated regulatory approval, either through the FDA’s 505(b)(2) approval pathway (COVID-19-related GI infections) or a potential breakthrough designation (ICI-AC). The result could greatly reduce development costs and timelines for FW-1022 and FW-420.

MS1819 – A Potential Advance in the Treatment of EPI

Phase 2b Monotherapy Trial
Recently, we announced topline results from our Phase 2b OPTION 2 clinical trial investigating MS1819 as a monotherapy in CF patients with EPI. As discussed on our March 31 conference call, results were mixed, although we did not consistently meet the primary efficacy endpoint of a coefficient of fat absorption (CFA) ≥80%. MS1819 demonstrated itself to be safe and well-tolerated and data from OPTION 2, and our other Phase 2 clinical trials, have clearly demonstrated drug activity. Some patients were able to achieve CFA at levels beyond what is required to demonstrate non-inferiority with PERT therapies, but the majority did not, and as such, we did not meet our trial goal.

We believe the underlying cause of the drug’s uneven efficacy performance in OPTION 2 lies with the formulation. In response, we are moving aggressively to develop a new formulation for MS1819 that utilizes a capsule filled with acid-resistant granules, or microbeads. Such a capsule is intended to dissolve in the stomach, disperse the beads, and then pass through to the small intestine where the beads would break down and release the lipase enzyme so that it thoroughly mixes with food and deliver the lipase enzyme in the duodenum.

We are now in a position to develop a microbead formulation similar to that used by the leading PERT brands in the market. Due to prior cost constraints, we were unable to develop a microbead formulation and conducted the OPTION 2 clinical trial using a powder formulation with different delivery mechanisms - both immediate release and delayed-release enteric capsules. This was a development pathway that certain PERT competitors initially pursued as well, because they too were unable to achieve a CFA ≥80% using powder immediate-release formulations. Once they reformulated their products using enteric-coated microbeads they were able to achieve CFA levels over 80%.

Furthermore, in addition to the acid-resistant microbead formulation, we have also been investing in several manufacturing processes designed to optimize production yields and incorporate more drug product into capsules - with the goals of reducing the cost of goods, improving competitive pricing, and further decreasing the number of daily capsules needed by patients. We continue to believe that we will be able to reduce pill burden and help improve patient compliance through process improvements.

Phase 2 Combination Therapy Program
In addition to the MS1819 monotherapy program, we continue to advance a Phase 2 clinical trial evaluating MS1819 in combination with PERT. Patient enrollment in this trial is complete, and we expect to report top line data in Q2 2021. As previously reported in August 2020, early data was encouraging, and we believe that the combination regimen has potential to help the approximately 25% to 30% of refractory CF patients with severe EPI who are unable to achieve adequate nutrition using PERT alone.

MS1819 -- A Clear Path Forward

We have already initiated discussions with contract manufacturers to develop the optimized microbead formulation of MS1819. We expect to have a product ready to advance into clinical studies by Q3 2021. This process will of course require more time and resources. However, to our benefit, we have sufficient capital on hand to fund this development.

We believe the cost-benefit profile with MS1819 is clearly in our favor. The drug has a proven mechanism of action and compared to PERTs, it offers numerous therapeutic, safety, and compliance advantages, while remaining relatively easy to manufacture. Based on these factors, we believe that if this optimized microbead formulation proves successful in the clinic and receives regulatory approval, MS1819 could eventually eclipse pig PERT as the standard of care, as similarly seen in the early 1980’s with the advent of synthetic “human” insulin which completely replaced the cow and pig derived insulin that had been used for treating diabetes.

Finance

During the first quarter of 2021, we raised aggregate gross proceeds of approximately $18.0 million from the sale of preferred stock and common stock in public offerings and private placement transactions, plus the receipt of aggregate cash proceeds of approximately $4.6 million from the exercise of warrants.

Outlook Ahead

These are exciting times for AzurRx and we anticipate several catalysts on the horizon. I look forward to working with my management team and fellow board members to execute a business and clinical strategy that has the potential to transform AzurRx and generate substantial returns for our shareholders.

We will continue to pursue our efforts to drive long-term shareholder value by delivering safe and effective GI therapies for patients who need them the most, raising our global visibility and broadening our shareholder base. We look forward to continuing what has been a productive 2021, and we thank you for your continued support.

Sincerely,
James Sapirstein
Chairman, President and CEO
AzurRx BioPharma, Inc.

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of three gut-restricted GI assets. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis. AzurRx is also advancing two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor; FW-1022, for COVID-19 GI infections and FW-420, for Grade 1 Immune Checkpoint Inhibitor-Associated Colitis and diarrhea in oncology patients. The Company is headquartered in Delray Beach, Florida with clinical operations in Hayward, California. For more information visit www.azurrx.com.

Forward-Looking Statement
This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; the size of the potential markets for the Company’s drug candidates and its ability to service those markets; and the Company’s current and future capital requirements and its ability to raise additional funds to satisfy its capital needs. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:

AzurRx BioPharma, Inc.
1615 South Congress Avenue
Suite 103
Delray Beach, Florida 33445
Phone: (646) 699-7855
This email address is being protected from spambots. You need JavaScript enabled to view it.

Media contact:

Tiberend Strategic Advisors, Inc.
Johanna Bennett/Ingrid Mezo
(212) 375-2665/(646) 604-5150
This email address is being protected from spambots. You need JavaScript enabled to view it./This email address is being protected from spambots. You need JavaScript enabled to view it.

References
1 Gut Journal: Vol 69, Issue 6: 2020; Gut Journal: Vol 69, Issue 6: 2020; JAMA Network: Vol 3, Issue 6: 2020; Lancet Gastroenterol Hepatol: Vol 5, Issue 5: 2020; Cheung Gastroenterology: Vol. 159, Issue 1: 2020.
2 Rubin, R. “As their numbers grow, COVID-19 “Long Haulers” Stump Experts”. https://jamanetwork.com/journals/jama/fullarticle/2771111 September 23, 2020.
3 Davis, et al. “Characterizing Long Covid in an International Cohort: 7 Months of Symptoms and their Impact”. https://www.medrxiv.org/content/10.1101/2020.12.24.20248802v2.full.pdf
4 Jeon S, Ko M, Lee J, Choi I, Byun SY, Park S, Shum D, Kim S. 2020. Identification of antiviral drug candidates against SARS-CoV-2 from FDA-approved drugs. Antimicrob Agents Chemother 64:e00819-20. https://doi.org/10.1128/AAC.00819-20.
5 Braga, L., Ali, H., Secco, I. et al. Drugs that inhibit TMEM16 proteins block SARS-CoV-2 Spike-induced syncytia. Nature (2021). https://doi.org/10.1038/s41586-021-03491-6


Phase 1b/2a Study Expected to Begin In 2Q 2021

DELRAY BEACH, Fla., April 13, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ: AZRX), (“AzurRx” or the “Company”), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced today that it has entered into an agreement with PPD, Inc. (NASDAQ: PPD), a leading global contract research organization (CRO), for its planned Phase 1b/2a clinical trial evaluating proprietary formulations of micronized niclosamide for grade 1 colitis and diarrhea in oncology patients receiving treatment with immune checkpoint inhibitors (ICIs). 

Under the terms of the agreement, PPD will manage the Phase 1b/2a clinical trial using both oral immediate-release tablet and topical rectal enema foam formulations of micronized oral niclosamide, also known as FW-420. AzurRx anticipates initiating the trial during the second quarter of 2021.

“The goal of our FW-420 clinical program is to develop a safe, effective, and non-systemic treatment for immune checkpoint inhibitor-associated colitis, and we are excited to once again partner with PPD to begin the preparations for our Phase 1b/2a clinical trial,” said James Sapirstein, President and CEO of AzurRx BioPharma. “The development of immune checkpoint inhibitors has marked a major advance in cancer therapeutics, but the drugs can induce a serious inflammation of the bowels, which if left unchecked, can prove life-threatening and force patients to halt treatment. There are currently no treatments available for grade 1 colitis resulting from the use of ICIs. We believe an oral, non-absorbed treatment, such as FW-420, could prevent the condition from progressing and enable patients to continue their treatment regimen uninterrupted. We hope to rapidly advance the FW-420 program with the support of PPD.”

The agreement with PPD marks the second clinical trial involving niclosamide that the CRO will manage for AzurRx. As previously announced, PPD is also managing AzurRx’s Phase 2 clinical trial to investigate niclosamide as a treatment for COVID-19-related gastrointestinal infections, planned for the second quarter of 2021.

Daniel Burch, M.D., Senior Vice President and Global Head of PPD® Biotech, stated, “We are pleased to have this opportunity to broaden our collaboration with AzurRx as it expands its clinical program for niclosamide to bring relief to patients suffering from immune checkpoint inhibitor-associated colitis. We look forward to utilizing our expertise and capabilities to advance the development of FW-420, beginning with the upcoming clinical trial.”

About Immune Checkpoint Inhibitor-Associated Colitis
Immune checkpoint inhibitors (ICIs) are monoclonal antibodies that target down-regulators of the anti-cancer immune response and have revolutionized the treatment of a variety of malignancies. The global market for ICIs is significant; it was over $22 billion in 2019 and growing rapidly.Approximately 44% of patients with advanced cancer tumors (more than 260,000 patients) are eligible to receive immune checkpoint inhibitors.

However, many immune-related adverse events, especially diarrhea and colitis, limit their use. The incidence of immune-mediated colitis (IMC) ranges from 1% to 25% depending on the type of ICI and whether they are used in combination used in combination.2 Approximately 30% of ICI patients develop diarrhea, which can progress to colitis. The onset of diarrhea in ICI-AC patients occurs within 6-7 weeks and progressively worsens, and the progression to colitis is rapid and unpredictable. For example, in patients taking ipilimumab (Yervoy), between 25% and 30% of patients developed diarrhea and roughly 8% to 12% developed colitis.3 Moreover, the trend is towards the use of combination ICI therapies (e.g., Yervoy and Opdivo) and this will lead to a concomitant increase in both diarrhea and colitis.

Administration of corticosteroids, or treatment with certain immunosuppressive biologics, while withholding ICI therapy are recommended for grade 2 or more severe colitis (National Cancer Institute 2020). The impact of this colitis complication and treatment may reduce the goal of progression free cancer survival. An oral, non-absorbed treatment, such as niclosamide, for grade 1 colitis (diarrhea) may prevent progression to grade 2 disease. There currently is no approved treatment for grade 1 colitis.

About Niclosamide
Niclosamide is a prescription small molecule drug listed as an essential medicine by the World Health Organization (WHO). Niclosamide has been safely used on millions of patients for other clinical indications. In the U.S., niclosamide was approved by the U.S. Food and Drug Administration (FDA) in 1982 for the treatment of intestinal tapeworm infections. In addition to its antihelminthic activity, niclosamide has demonstrated anti-inflammatory and anti-viral properties.

About FW-420
FW-420 is a niclosamide-based small molecule anti-inflammatory inhibitor therapy for the treatment of immune checkpoint inhibitor-associated colitis (ICI-AC) and diarrhea in metastatic cancer patients.  FW-420 will be supplied in two formulations, as an oral immediate-release tablet and as a topical rectal enema foam. The standard care for treating inflammatory bowel diseases (IBD) such as ulcerative colitis and Crohn’s Disease, corticosteroids and 5-ASAs, can cause problems when used for check point inhibitor patients due to their immunosuppressant effects. FW-420 has the potential to safely treat grade 1 ICI-associated colitis and diarrhea and prevent its progression to more serious and potentially fatal later stages. The overall goal of early niclosamide treatment is to enable oncology patients to remain on, or spend minimal time off, their ICI treatment programs without interruption.

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of three gut-restricted GI assets. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis. AzurRx is also advancing two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor: FW-1022, for COVID-19 gastrointestinal infections and FW-420, for grade 1 Immune Checkpoint Inhibitor-associated colitis and diarrhea in oncology patients. The Company is headquartered in Delray Beach, Florida with clinical operations in Hayward, California. For more information visit www.azurrx.com.

About PPD
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our customers include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and more than 26,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help customers bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health. For more information, visit www.ppd.com.

Forward-Looking Statement
This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including potential delays in clinical trial recruitment and participation. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:

AzurRx BioPharma, Inc.
1615 South Congress Avenue
Suite 103
Delray Beach, Florida 33445
Phone: (646) 699-7855
This email address is being protected from spambots. You need JavaScript enabled to view it.

Media contact:

Tiberend Strategic Advisors, Inc.
Johanna Bennett/Ingrid Mezo
(212) 375-2665/(646) 604-5150
This email address is being protected from spambots. You need JavaScript enabled to view it./This email address is being protected from spambots. You need JavaScript enabled to view it.

1 Immune Checkpoint Inhibitors Market, ResearchAndMarkets.com, 2020.
2 Wang et al. Patients with ICPI-induced diarrhea or colitis have improved survival outcomes. J Immunother Cancer. 2018; 6: 37. Som et al., World J Clin Cases. Feb 26, 2019; 7(4): 405-418
3 Wang DY, Ye F, Zhao S, et al. Incidence of immune checkpoint inhibitor-related colitis in solid tumor patients: a systematic review and meta-analysis. Oncoimmunology 2017; 10: e1344805; Som et al., World J Clin Cases. Feb 26, 2019; 7(4): 405-418


“RESERVOIR” trial to evaluate niclosamide’s ability to target SARS-CoV-2 in the GI tract

Topline data expected in Q1 2022

DELRAY BEACH, Fla., April 06, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ: AZRX), (“AzurRx” or the “Company”), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced today that it has initiated its Phase 2 RESERVOIR clinical trial of a proprietary oral formulation of micronized niclosamide (FW-1022) for the treatment of COVID-19 related gastrointestinal (GI) infections. Patient enrollment is expected to begin in April 2021 with topline data anticipated in Q1 2022.

The Phase 2 RESERVOIR clinical trial is a two-part, two-arm, placebo-controlled study examining the safety and efficacy of micronized oral niclosamide tablets, known as FW-1022, in patients with COVID-19 GI infection. The two primary objectives of this trial will be to confirm the safety of niclosamide in the treatment of patients with COVID-19 GI infection and to demonstrate efficacy in clearing the SARS-CoV-2 virus from the GI tract. The primary efficacy measure of the RESERVOIR trial is the rate of fecal SARS-CoV-2 virus clearance (rectal swab or stool sample) assessed by RT-PCR, comparing the niclosamide arm to the placebo arm for up to six months. These long term observation data could indicate that niclosamide treatment has the potential to improve ‘long haul’ COVID-19 symptoms. 

As previously announced, the trial will be managed by PPD, Inc. (NASDAQ: PPD), a leading global contract research organization (CRO).

“Initiation of the Phase 2 clinical trial of FW-1022 for the treatment of COVID-19 GI infection, or the RESERVOIR trial, is a significant milestone for AzurRx and an important advance in the ongoing battle to help those infected by COVID-19 to overcome the often long-lasting effects of the virus,” said James Sapirstein, Chairman, CEO and President of AzurRx BioPharma. “COVID-19 is a pernicious disease and, despite the ongoing vaccine rollout, one that continues to impact hundreds of thousands of people worldwide every day in addition to the millions who have already been infected. For many, the after-effects of COVID-19 can be as bad as the disease itself, and this includes a growing number who experience severe GI complications due to what many believe is the ability of SARS-CoV-2 to hide in reservoirs within the GI tract. We believe micronized oral niclosamide has the potential to target SARS-CoV-2 directly in the gut and, doing so, become an important addition to the armamentarium of therapeutics that will unfortunately be required by many who contract COVID-19.”

“So called ‘long haul COVID’ cases are becoming a major problem globally, and it is reasonable to expect the GI tract may serve as a silent reservoir,” added Dr. James Pennington, Chief Medical Officer of AzurRx. “We believe that niclosamide is ideally equipped to eradicate these hidden GI SARS-CoV-2 reservoirs due to its proven safety profile, known effectiveness in treating other GI ailments, and unique ability to remain in the gut for long periods of time. These properties, we believe, will be accentuated by our micronized formulation of niclosamide, which allows for local concentrations in the gut that exceed those needed to kill SARS-CoV-2. We look forward to testing this hypothesis in the RESERVOIR Phase 2 trial and reporting topline data from the trial in early 2022.”

More information about this clinical trial is available at ClinicalTrials.gov.

About Phase 2 RESERVOIR Clinical Trial

The Phase 2 RESERVOIR clinical trial is a two-part, two-arm, placebo-controlled study examining the safety and efficacy of an immediate-release capsule formulation of micronized oral niclosamide, known as FW-1022, in patients with COVID-19 GI infection. The two primary objectives of this trial will be to show safety of niclosamide in treatment of patients with COVID-19 GI infection, and to show efficacy in clearing the SARS-CoV-2 (SARS2) virus from the GI tract.  Part 1 of the trial will study 9 to 18 patients hospitalized with COVID-19 and GI positive stool or rectal swabs for SARS2.  Patients will be treated for 14 days and observed closely for any signs of safety issues.  A Data Monitoring Committee will then review the safety profile and if niclosamide is well-tolerated, the trial will move on to Part 2. 

Part 2 will be conducted in outpatients with COVID-19 and PCR positive stool or rectal swabs for SARS2.  Patients will be randomized to either niclosamide, 400 mg tablets, three times a day, or placebo tablets three times a day.  After 14 days of treatment, patients will be taken off study drugs and remain on study observation for up to 6 months. The primary efficacy measure of the trial is the rate of fecal SARS2 virus clearance (rectal swab or stool sample) assessed by RT-PCR, comparing the niclosamide arm to the placebo arm. Long term observation will also be important to indicate whether niclosamide treatment might improve ‘long haul’ COVID-19 symptoms.  Approximately 100 patients will be studied in Part 2.

An IND for the trial has been approved by the FDA, and the trial expects to begin enrolling patients in April 2021. Top line data are expected Q2 2021.

About COVID-19 Gastrointestinal Infections
Gastrointestinal infection symptoms (severe diarrhea, vomiting and abdominal pain) have been reported in approximately 18% of COVID-19 cases1. Of the 26.6 million individuals who are reported to have contracted COVID-19 in the U.S., this would translate into 4.8 million patients having GI infection. Of the 105 million cases globally, it would translate into almost 19 million patients.

There is some evidence to support the view that the GI tract is a possible reservoir for recurrence and fecal spread of the COVID-19 virus as ACE-2, the entry receptor for COVID-19, is highly expressed on GI cells. There currently is no targeted treatment for COVID GI infections.

About Niclosamide

Niclosamide is a prescription small molecule drug listed as an essential medicine by the World Health Organization (WHO). Niclosamide has been safely used on millions of patients for other clinical indications.  In the U.S., niclosamide was approved by the U.S. Food and Drug Administration (FDA) in 1982 for the treatment of intestinal tapeworm infections. In addition to its antihelminthic activity, niclosamide has demonstrated anti-inflammatory and anti-viral properties.

There remains an urgent need to develop new medicines that can be manufactured at large scale quickly to treat COVID-19. Niclosamide was recently identified by the Institut Pasteur Korea as a potent inhibitor of SARS-CoV-2, the virus causing COVID-19, with potency 40X greater than remdesivir.2 Additionally, emerging evidence confirms the severe GI-related complications of COVID and potential fecal spread of the virus. The Company’s clinical trials may establish that patients treated with an oral and non-systemic niclosamide formulation that delivers high local GI concentrations have decreased viral load and GI-associated symptoms of COVID. Importantly, the manufacturing process for niclosamide can be scaled up to supply large populations quickly.

FW-1022

FW-1022 is a niclosamide based small molecule which the Company’s clinical trials may establish has anti-viral activity that is effective for the treatment of SARS-CoV-2 (COVID-19) gastrointestinal infections. FW-1022 will be supplied as an oral immediate release tablet. The formulation to be used has been milled (micronized) to allow superior dissolution in the gut fluids. This in turn may allow local niclosamide concentrations to reach anti-viral levels. Thus, FW-1022 has the potential to benefit COVID patients by decreasing viral load in the GI tract, treating infection symptoms and preventing transmission of the virus through fecal spread.

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of three gut-restricted GI assets. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis, currently in two Phase 2 clinical trials. AzurRx is launching two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor; FW-1022, for COVID-19 gastrointestinal infections and FW-420, for grade 1 Immune Checkpoint Inhibitor-Associated Colitis and diarrhea in oncology patients. The Company is headquartered in Delray Beach, Florida with clinical operations in Hayward, California. For more information visit www.azurrx.com.

Forward-Looking Statement
This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including potential delays in clinical trial recruitment and participation. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:

AzurRx BioPharma, Inc.
1615 South Congress Avenue
Suite 103
Delray Beach, Florida 33445
Phone: (646) 699-7855
This email address is being protected from spambots. You need JavaScript enabled to view it.

Media contact:

Tiberend Strategic Advisors, Inc.
Johanna Bennett/Ingrid Mezo
(212) 375-2665/(646) 604-5150
This email address is being protected from spambots. You need JavaScript enabled to view it./This email address is being protected from spambots. You need JavaScript enabled to view it.

1 Gut Journal: Vol 69, Issue 6: 2020; Gut Journal: Vol 69, Issue 6: 2020; JAMA Network: Vol 3, Issue 6: 2020; Lancet Gastroenterol Hepatol: Vol 5, Issue 5: 2020; Cheung Gastroenterology: Vol. 159, Issue 1: 2020
2 Jeon S, Ko M, Lee J, Choi I, Byun SY, Park S, Shum D, Kim S. 2020. Identification of antiviral drug candidates against SARS-CoV-2 from FDA-approved drugs. Antimicrob Agents Chemother 64:e00819-20. https://doi.org/10.1128/AAC.00819-20.


DELRAY BEACH, Fla., March 31, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ: AZRX), (“AzurRx” or the “Company”), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today provided key takeaways from its conference call reporting on the topline results from its Phase 2b OPTION 2 clinical trial investigating MS1819 in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI). The conference call, held on March 31, 2021, at 4:30 p.m. ET, featured James Sapirstein, President, CEO and Chairman of AzurRx, and Dr. James Pennington, Chief Medical Officer, discussing the recently completed OPTION 2 study, and the company’s plans to develop an optimized formulation of MS1819 for ongoing clinical investigation.

OPTION 2 was designed as a Phase 2b multi-center study to investigate the safety, tolerability and efficacy of MS1819 (in enteric capsules) in a head-to-head comparison against the current porcine enzyme replacement therapy (PERT) standard of care for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis. The primary efficacy endpoint was the coefficient of fat absorption (CFA), with secondary endpoints of stool weight, signs and symptoms of malabsorption and coefficient of nitrogen absorption (CNA). The trial also included an extension arm that used an immediate release MS1819 capsule, allowing the Company to compare data from the existing arm that uses enteric (delayed release) capsules with data from the new arm, and ultimately select the optimal delivery method.

Discussing the topline results of OPTION 2 during the conference call, Mr. Sapirstein commented, “To summarize, the best word to describe the OPTION 2 topline results is mixed. MS1819 demonstrated itself to be safe and well-tolerated and data from OPTION 2, and other Phase 2 clinical trials, clearly demonstrate drug activity. However, OPTION 2 did not consistently meet the primary efficacy endpoint. Some patients were able to achieve CFA at levels beyond what is required to demonstrate non-inferiority with PERT therapies, but the majority did not, and as such, we did not meet our trial goal.”

Mr. Sapirstein continued, “The underlying cause of the drug’s uneven efficacy performance in OPTION 2, we believe, lies with the enteric capsule formulation. While the enteric coating protects the capsule from breaking down in the stomach acid, it also appears to dissolve too slowly in the small intestine to release the lipase enzyme in time to aid with proper digestion and nutrient absorption.”  

“To that end, we are planning to pursue a new formulation for MS1819, this one a capsule filled with acid-resistant granules, or microbeads, similar to what is used in CREON®, ZENPEP® and other PERT therapies. Such a capsule would dissolve in the stomach, disperse the beads, and then pass through to the small intestine where the beads would break down and release the lipase enzyme so that it thoroughly mixes with food as it is being digested.”

Mr. Sapirstein concluded, “We are moving full force with developing the optimal formulation technology for MS1819 and have already initiated discussions with contract manufacturers to accelerate the process. This will require additional time and resources. Yet we are fortunate, through financing efforts that have raised an aggregate of approximately $22.5 million in the first quarter of 2021, to have sufficient capital currently on hand to fund this development and, within the next year or so, initiate a further Phase 2 study to evaluate efficacy, without substantially delaying our clinical development initiatives in other areas.

We firmly believe the cost-benefit ratio with MS1819 is clearly in our favor. The drug’s mechanism of action is known and proven, it offers numerous therapeutic, safety and compliance advantages over today’s standard of care, and remains less cumbersome to manufacture. Based on these factors, we believe that should this optimized formulation prove successful in the clinic – and we have every reason to believe it will – MS1819 could eventually become the gold standard treatment for EPI in patients with cystic fibrosis and chronic pancreatitis.”

An audio webcast of the conference call will be accessible via the Investors section of the AzurRx website at www.azurrx.com. An archive of the webcast will remain available for approximately 90 days.

Phase 2 OPTION 2 Trial Design
The Phase 2b OPTION 2 multi-center trial was designed to investigate the safety, tolerability and efficacy of MS1819 (2.2 and 4.4 gram doses in enteric capsules) in a head-to-head comparison versus the current standard of care, porcine pancreatic enzyme replacement therapy pills. The OPTION 2 trial was an open-label, crossover study, conducted in 15 sites in the U.S. and Europe. A total of 30 CF patients 18 years or older were enrolled. MS1819 was administered in enteric capsules to provide gastric protection and allow optimal delivery of enzyme to the duodenum. Patients were first randomized into two cohorts: to either the MS1819 arm, where they received a 2.2 gram daily oral dose of MS1819 for three weeks; or to the PERT arm, where they received their pre-study dose of PERT pills for three weeks. After three weeks, stools were collected for analysis of coefficient of fat absorption. Patients were then crossed over for another three weeks of the alternative treatment. After three weeks of cross-over therapy, stools were again collected for analysis of CFA. A parallel group of patients were randomized and studied in the same fashion, using a 4.4 gram daily dose of MS1819. All patients were followed for an additional two weeks after completing both crossover treatments for post study safety observation. Patients were assessed using descriptive methods for efficacy, comparing CFA between MS1819 and PERT arms, and for safety.

About MS1819
MS1819 is a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis. MS1819, supplied as an oral non-systemic biologic capsule, is derived from the Yarrowia lipolytica yeast lipase and breaks up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients. Unlike the standard of care, the MS1819 synthetic lipase does not contain any animal products.

About Exocrine Pancreatic Insufficiency
EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in a patient’s inability to digest food properly, or maldigestion. The deficiency in this enzyme can be responsible for greasy diarrhea, fecal urge and weight loss.

There are more than 30,000 patients in the U.S. with EPI caused by cystic fibrosis according to the Cystic Fibrosis Foundation and approximately 90,000 patients in the U.S with EPI caused by chronic pancreatitis according to the National Pancreas Foundation. Patients are currently treated with porcine pancreatic enzyme replacement pills.

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of three gut-restricted GI assets. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis, currently in two Phase 2 CF clinical trials. AzurRx is launching two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor; FW-1022, for COVID-19 gastrointestinal infections, and FW-420, for grade 1 Immune Checkpoint Inhibitor-Associated Colitis and diarrhea in oncology patients. The Company is headquartered in Delray Beach, Florida with clinical operations in Hayward, California. For more information visit www.azurrx.com.

Forward-Looking Statement
This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including potential delays in clinical trial recruitment and participation. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:

AzurRx BioPharma, Inc.
1615 South Congress Avenue
Suite 103
Delray Beach, Florida 33445
Phone: (646) 699-7855
This email address is being protected from spambots. You need JavaScript enabled to view it.

Media contact:

Tiberend Strategic Advisors, Inc.
Johanna Bennett/Ingrid Mezo
(212) 375-2665/(646) 604-5150
This email address is being protected from spambots. You need JavaScript enabled to view it./This email address is being protected from spambots. You need JavaScript enabled to view it.

 


AzurRx to Host Conference Call and Live Audio Webcast Today, Wednesday, March 31, 2021 at 4:30 p.m. ET

DELRAY BEACH, Fla., March 31, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ: AZRX), (“AzurRx” or the “Company”), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced today that the Company will host a conference call and live audio webcast today, Wednesday, March 31, 2021, at 4:30 p.m. ET, to discuss the topline results from its Phase 2b OPTION 2 clinical trial investigating MS1819 in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI).

Interested participants and investors may access the conference call by dialing either:

  • (833) 607-1647 (U.S.)
  • (914) 987-7760 (international)
  • Conference ID: 5145118

OPTION 2 was designed as a Phase 2b multi-center study to investigate the safety, tolerability and efficacy of MS1819 (in enteric capsules) in a head-to-head comparison against the current porcine enzyme replacement therapy (PERT) standard of care. The primary efficacy endpoint was the coefficient of fat absorption (CFA), with secondary endpoints of stool weight, signs and symptoms of malabsorption and coefficient of nitrogen absorption (CNA). The trial also included an extension arm that used an immediate release MS1819 capsule, allowing the Company to compare data from the existing arm that uses enteric (delayed release) capsules with data from the new arm, and ultimately select the optimal delivery method.

An audio webcast of the conference call will be accessible via the Investors section of the AzurRx website https://azurrx.com/. An archive of the webcast will remain available for 90 days beginning at approximately 5:30 p.m. ET, on March 31, 2021.

Phase 2 OPTION 2 Trial Design
The Phase 2b OPTION 2 multi-center trial was designed to investigate the safety, tolerability and efficacy of MS1819 (2.2 and 4.4 gram doses in enteric capsules) in a head-to-head comparison versus the current standard of care, porcine pancreatic enzyme replacement therapy pills. The OPTION 2 trial was an open-label, crossover study, conducted in 15 sites in the U.S. and Europe. A total of 30 CF patients 18 years or older were enrolled. MS1819 was administered in enteric capsules to provide gastric protection and allow optimal delivery of enzyme to the duodenum. Patients were first randomized into two cohorts: to either the MS1819 arm, where they received a 2.2 gram daily oral dose of MS1819 for three weeks; or to the PERT arm, where they received their pre-study dose of PERT pills for three weeks. After three weeks, stools were collected for analysis of coefficient of fat absorption. Patients were then crossed over for another three weeks of the alternative treatment. After three weeks of cross-over therapy, stools were again collected for analysis of CFA. A parallel group of patients were randomized and studied in the same fashion, using a 4.4 gram daily dose of MS1819. All patients were followed for an additional two weeks after completing both crossover treatments for post study safety observation. Patients were assessed using descriptive methods for efficacy, comparing CFA between MS1819 and PERT arms, and for safety.

About MS1819
MS1819 is a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis. MS1819, supplied as an oral non-systemic biologic capsule, is derived from the Yarrowia lipolytica yeast lipase and breaks up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients. Unlike the standard of care, the MS1819 synthetic lipase does not contain any animal products.

About Exocrine Pancreatic Insufficiency
EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in a patient’s inability to digest food properly, or maldigestion. The deficiency in this enzyme can be responsible for greasy diarrhea, fecal urge and weight loss.

There are more than 30,000 patients in the U.S. with EPI caused by cystic fibrosis according to the Cystic Fibrosis Foundation and approximately 90,000 patients in the U.S. with EPI caused by chronic pancreatitis according to the National Pancreas Foundation. Patients are currently treated with porcine pancreatic enzyme replacement pills.

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of three gut-restricted GI assets. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis, currently in two Phase 2 clinical trials. AzurRx is launching two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor; FW-420, for grade 1 Immune Checkpoint Inhibitor-Associated Colitis and diarrhea in oncology patients and FW-1022, for COVID-19 gastrointestinal infections. The Company is headquartered in Delray Beach, Florida with clinical operations in Hayward, California. For more information visit www.azurrx.com.

Forward-Looking Statement
This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including potential delays in clinical trial recruitment and participation. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:

AzurRx BioPharma, Inc.
1615 South Congress Avenue
Suite 103
Delray Beach, Florida 33445
Phone: (646) 699-7855
This email address is being protected from spambots. You need JavaScript enabled to view it.

Media contact:

Tiberend Strategic Advisors, Inc.
Johanna Bennett/Ingrid Mezo
(212) 375-2665/(646) 604-5150
This email address is being protected from spambots. You need JavaScript enabled to view it./This email address is being protected from spambots. You need JavaScript enabled to view it.


Top-line data expected in Q2 2021

DELRAY BEACH, Fla., March 22, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ: AZRX), (“AzurRx” or the “Company”), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced it has completed enrollment in its Phase 2 trial evaluating MS1819 in combination with the current standard of care, porcine-derived pancreatic enzyme replacement therapy (PERT), for the treatment of severe exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF).

“We are very pleased to have completed enrollment in our Phase 2 MS1819 plus PERT combination therapy clinical trial,” said James Sapirstein, President, CEO and Chairman of AzurRx. “Based on the very encouraging clinical results to date, we believe that the combination therapy has significant potential to help the 25-30% of refractory cystic fibrosis patients with severe EPI who are unable to achieve adequate nutrition using PERT alone. Adding a small dose of MS1819 can help these patients meet their nutritional needs, reduce the debilitating symptoms of EPI and improve their overall quality of life, with an increased safety profile.”

Mr. Sapirstein continued, “The combination therapy program represents a second therapeutic opportunity for the MS1819 program. We reported the completion of enrollment of our Phase 2 monotherapy program – OPTION 2 – last week and will announce topline results for that trial at the end of March. We continue to remain on target to report topline results from the combination therapy study during the second quarter of 2021.”

“The overarching goal of our MS1819 program is to provide a safe and effective therapy to control EPI, a debilitating gastrointestinal condition common to patients with cystic fibrosis that can result in numerous, life-altering complications, including malnutrition,” added Dr. James Pennington, Chief Medical Officer of AzurRx. “Early clinical evidence has been promising, and with the combination and OPTION 2 monotherapy trials progressing, we may soon have the opportunity to introduce a drug product that could potentially improve the lives of thousands of patients suffering from cystic fibrosis.”

The Phase 2 combination clinical trial of MS1819 is a multi-center study designed to investigate the safety, tolerability and efficacy of escalating doses of MS1819, in conjunction with a stable dose of PERT in order to increase the patient’s coefficient of fat absorption (CFA) levels and relieve abdominal symptoms. The study enrolled 18 patients, 12 years of age or older, with severe EPI. Patients enrolled in the study receive escalating doses of 700mg, 1200mg, and 2240mg of MS1819 once daily for 15 days per dosing level, in addition to their standard PERT dose. Baseline CFA is established by measuring CFA levels while on standard of care therapy only, before beginning combination therapy. Eligibility requires a CFA of less than 80%. The primary efficacy endpoint of the trial is improvement in CFA; secondary endpoints of the study are improvements in the stool weight, stool consistency, number of bowel movements, the incidence of steatorrhea, and increase of body weight.

Previously reported results from the initial five patients in the trial revealed that the combination therapy led to clinically meaningful improvements in the primary efficacy endpoint, the CFA, and improvements in the key secondary endpoints, including body weight, stool consistency and reductions in the number of bowel movements and the incidence of steatorrhea (excessive amounts of fat in the feces).

Additional information about this clinical trial can be found at: https://clinicaltrials.gov/ct2/show/NCT04302662

About the MS1819 Combination Therapy Study
The digestive standard of care for both CF and chronic pancreatitis (CP) patients with EPI are commercially-available PERTs. Ideally, a stable daily dose of PERT will enable CF patients to eat a normal to high-fat diet and minimize unpleasant gastrointestinal symptoms. In practice, however, a substantial number of CF patients do not achieve normal absorption of fat with PERTs1,2. Achieving an optimal nutritional status, including normal fat absorption levels, in CF patients is important for maintaining better pulmonary function, physical performance and prolonging survival. Furthermore, a decline of body mass index around the age of 18 years predicts a substantial drop in lung function3,4.

A combination therapy of PERT and MS1819 has the potential to: (i) correct macronutrient and micronutrient maldigestion; (ii) eliminate abdominal symptoms attributable to maldigestion; and (iii) sustain optimal nutritional status on a normal diet in CF patients with severe EPI. Planned enrollment is expected to include approximately 20 CF patients with severe EPI, with study completion anticipated in 1H 2021.

About MS1819
MS1819 is a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis. MS1819, supplied as an oral, non-systemic, biologic capsule, is derived from the Yarrowia lipolytica yeast lipase and breaks up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients. Unlike the standard of care, the MS1819 synthetic lipase does not contain any animal products.

About Exocrine Pancreatic Insufficiency
EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in a patient’s inability to digest food properly, or maldigestion. The deficiency in this enzyme can be responsible for greasy diarrhea, fecal urge and weight loss.

There are more than 30,000 patients in the U.S. with EPI caused by cystic fibrosis according to the Cystic Fibrosis Foundation and approximately 90,000 patients in the U.S with EPI caused by chronic pancreatitis according to the National Pancreas Foundation. Patients are currently treated with porcine pancreatic enzyme replacement pills.

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of three gut-restricted GI assets. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis, currently in two Phase 2 clinical trials.  AzurRx is launching two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor, FW-420, for grade 1 Immune Checkpoint Inhibitor Colitis and diarrhea in oncology patients and FW-1022, for COVID-19 gastrointestinal infections. The Company is headquartered in Delray Beach, Florida with clinical operations in Hayward, California. For more information, visit www.azurrx.com.

Forward-Looking Statement
This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including potential delays in clinical trial recruitment and participation. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:
AzurRx BioPharma, Inc.
1615 South Congress Avenue
Suite 103
Delray Beach, Florida 33445
Phone: (646) 699-7855
This email address is being protected from spambots. You need JavaScript enabled to view it.

Media contact:
Tiberend Strategic Advisors, Inc.
Johanna Bennett/Ingrid Mezo
(212) 375-2665/(646) 604-5150
This email address is being protected from spambots. You need JavaScript enabled to view it./This email address is being protected from spambots. You need JavaScript enabled to view it.


1 Freedman, S.D., Am. J. Manag. Care, 2017; 23: S2220-S228
2 Littlewood, J. et al, 2006, Pediatric Pulmonology, 2006, 41:35-49
3 Engelen, M. et al, 2014, Curr. Opin. Clin. Nutr. Metab. Care; 17(6):515-520
4 Vandenbranden, S.L. et al, 2012, Pediatric Pulmonology, 2012; 47(2): 135-143


Top-line data expected by end of Q1 2021

DELRAY BEACH, Fla., March 16, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ: AZRX), (“AzurRx” or the “Company”), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced it has completed enrollment for its Phase 2b OPTION 2 clinical trial to investigate MS1819 in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI). The trial enrolled 30 CF patients and top line data from the study is anticipated by the end of Q1 2021.

The Phase 2b multi-center study is designed to investigate the safety, tolerability and efficacy of MS1819 in enteric capsules) in a head-to-head comparison against the current porcine enzyme replacement therapy (PERT) standard of care. The primary efficacy endpoint is the coefficient of fat absorption (CFA), with secondary endpoints of stool weight, signs and symptoms of malabsorption and coefficient of nitrogen absorption (CNA). The trial also includes an extension arm that uses an immediate release MS1819 capsule, allowing the Company to compare data from the existing arm that uses enteric (delayed release) capsules with data from the new arm, and ultimately select the optimal delivery method.

“Completion of enrollment in our Phase 2b OPTION 2 trial is an important milestone in the clinical development of MS1819 as an EPI monotherapy for patients with cystic fibrosis,” said James Sapirstein, CEO, President and Chairman of AzurRx. “Data from this trial will inform the optimal dose for a potential pivotal Phase 3 study, and we are on target to report topline results from this study at the end of the first quarter of 2021.”

Dr. James Pennington, Chief Medical Officer of AzurRx, added, “The overarching goal of our MS1918 program is to provide a safe and effective therapy to control EPI and improve upon the current standard of care, PERT, which is porcine-derived and requires patients to take upwards of 40 capsules per day to control symptoms. MS1819 is a synthetic lipase that does not contain any animal products and offers the potential to substantially reduce the daily pill burden currently required to manage EPI.”  

Additional information about this clinical trial can be found at: https://www.clinicaltrials.gov/ct2/show/NCT04375878

Phase 2 OPTION 2 Trial Design
The Phase 2b OPTION 2 multi-center trial is designed to investigate the safety, tolerability and efficacy of MS1819 (2.2 and 4.4 gram doses in enteric capsules) in a head-to-head comparison versus the current standard of care, porcine pancreatic enzyme replacement therapy pills. The OPTION 2 trial is an open-label, crossover study, conducted in 15 sites in the U.S. and Europe. A total of 30 CF patients 18 years or older are enrolled. MS1819 will be administered in enteric capsules to provide gastric protection and allow optimal delivery of enzyme to the duodenum. Patients will first be randomized into two cohorts: to either the MS1819 arm, where they receive a 2.2 gram daily oral dose of MS1819 for three weeks; or to the PERT arm, where they receive their pre-study dose of PERT pills for three weeks. After three weeks, stools will be collected for analysis of coefficient of fat absorption. Patients will then be crossed over for another three weeks of the alternative treatment. After three weeks of cross-over therapy, stools will again be collected for analysis of CFA. A parallel group of patients will be randomized and studied in the same fashion, using a 4.4 gram daily dose of MS1819. All patients will be followed for an additional two weeks after completing both crossover treatments for post study safety observation. Patients will be assessed using descriptive methods for efficacy, comparing CFA between MS1819 and PERT arms, and for safety.

About MS1819
MS1819 is a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis. MS1819, supplied as an oral non-systemic biologic capsule, is derived from the Yarrowia lipolytica yeast lipase and breaks up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients. Unlike the standard of care, the MS1819 synthetic lipase does not contain any animal products.

About Exocrine Pancreatic Insufficiency
EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in a patient’s inability to digest food properly, or maldigestion. The deficiency in this enzyme can be responsible for greasy diarrhea, fecal urge and weight loss.

There are more than 30,000 patients in the U.S. with EPI caused by cystic fibrosis according to the Cystic Fibrosis Foundation and approximately 90,000 patients in the U.S with EPI caused by chronic pancreatitis according to the National Pancreas Foundation. Patients are currently treated with porcine pancreatic enzyme replacement pills.

About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of three gut-restricted GI assets. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis, currently in two Phase 2 clinical trials. AzurRx is launching two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor, FW-420, for grade 1 Immune Checkpoint Inhibitor Colitis and diarrhea in oncology patients and FW-1022, for COVID-19 gastrointestinal infections. The Company is headquartered in Delray Beach, Florida with clinical operations in Hayward, California. For more information, visit www.azurrx.com.

Forward-Looking Statement
This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including potential delays in clinical trial recruitment and participation. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:
AzurRx BioPharma, Inc.
1615 South Congress Avenue
Suite 103
Delray Beach, Florida 33445
Phone: (646) 699-7855
This email address is being protected from spambots. You need JavaScript enabled to view it.

Media contact:
Tiberend Strategic Advisors, Inc.
Johanna Bennett/Ingrid Mezo
(212) 375-2665/(646) 604-5150
This email address is being protected from spambots. You need JavaScript enabled to view it./This email address is being protected from spambots. You need JavaScript enabled to view it.