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  • For the treatment of COVID-19 gastrointestinal (GI) infections

FW-1022 is a niclosamide-based, small molecule which AzurRx is developing for the treatment of SARS-CoV-2 (COVID-19)-related 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.

FW-1022 has the potential to benefit COVID-19 patients by decreasing viral load in the GI tract, treating infection symptoms, such as diarrhea and abdominal pain, and preventing transmission of the virus through fecal spread.

FW-1022 is currently the subject of a Phase 2 clinical trial (RESERVOIR).  RESERVOIR is designed as a two-part, two-arm, placebo-controlled study examining the safety and efficacy of FW-1022 in patients with COVID-19-related GI infections. The two primary objectives of this trial will be to show safety of niclosamide in treatment of patients with COVID-19-related GI infections, and to show efficacy in clearing the SARS-CoV-2 virus from the GI tract. 

Given niclosamide’s safety profile in other indications, AzurRx believes that it can be safely used for both patients who exhibit GI infection symptoms and patients who test positive for the virus. This drug also has the potential for accelerated regulatory approval through the FDA 505(b)(2) pathway.

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. Niclosamide avoids steroid-related complications and it is not systemically absorbed, allowing for higher local GI concentrations.

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. There remains an urgent need to develop new medicines such as niclosamide that can be quickly manufactured at large scale to treat COVID-19.

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COVID-19-Related GI Infections

There is evidence that SARS-CoV-2, the virus that causes COVID-19, can hide in the gastrointestinal system following infection, leading to severe GI complications, the  recurrence of COVID-19, and potential fecal spread of the virus. A recent study reported that 18% (almost one in five) COVID-19 patients reported GI symptoms and almost 50% had viral RNA in their stool.

There currently is no targeted treatment for COVID-19 GI infections despite the urgent need to reduce the burden for patients and the potential for transmission in hospitals. Vaccinating a global population will take years, and it’s likely that boosters will be required to sustain the vaccine’s effect, particularly given the emerging virus variants.  Therefore, SARS-CoV-2 infections will continue to occur for some time, necessitating the development of therapeutics to treat the disease.

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Clinical Trials