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AzurRx Administer First Dose Of FW-1022 In Phase 2 Niclosamide Trial To Treat COVID-19 GI Infections

AzurRx BioPharma, Inc. (AZRX), a clinical stage biopharmaceutical company focused on gastrointestinal diseases, announced Monday the administration of the first dose of FW-1022 to a volunteer in the ongoing Phase 2 RESERVOIR clinical trial. The trial will evaluate niclosamide's ability to target SARS-CoV-2 in the GI tract.

FW-1022 is a proprietary oral tablet formulation of micronized niclosamide developed for the treatment of COVID-19-related GI infections. The company expects to report topline results from the trial in the first quarter of 2022.

Niclosamide is a prescription small molecule drug listed as an essential medicine by the World Health Organization. In the U.S., niclosamide was approved by the U.S. Food and Drug Administration in 1982 for the treatment of intestinal tapeworm infections.

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.

The 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 company noted that the primary efficacy measure of the RESERVOIR trial is the rate of fecal SARS-CoV-2 clearance 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.

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