AzurRx BioPharma Activates New Clinical Trial Sites in India for Phase 2 RESERVOIR Trial Evaluating Niclosamide for the Treatment of COVID-19 Gastrointestinal Infections
BOCA RATON, Fla., Sept. 10, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (“AzurRx” or the “Company”) (NASDAQ: AZRX), a company specializing in the development of targeted non-systemic, therapies for gastrointestinal (GI) diseases, today announced the activation of seven (7) new clinical trial sites in India for the ongoing RESERVOIR trial evaluating FW-1022. FW-1022 is a proprietary oral tablet formulation of micronized niclosamide developed for the treatment of COVID-19-related GI infections.
The seven new clinical trial sites in India, together with the existing eleven sites in the U.S. and the five trial sites recently added in the Ukraine, brings the total number of RESERVOIR trial sites to twenty-three. AzurRx expects to report topline results during the first quarter of 2022.
“Expanding our clinical trial into India provides access to the second most populous country in the world and one that, unfortunately, continues to experience a devastating COVID-19 outbreak,” said James Sapirstein, President and CEO of AzurRx BioPharma. “Despite the global vaccination effort, COVID-19, and the new Delta variant, remain pernicious. Infection rates in India average 38,000 a day with more than 31.1 million people infected overall. The virus’ impact on the GI tract is often overshadowed by its effect on the respiratory system, however COVID-19-related GI infection remains an undertreated symptom with devastating aftereffects. A safe and effective treatment that removes the virus from the gut is needed for the millions who have contracted and continue to fall victim to the virus.”
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, the virus that causes COVID-19, from the GI tract. The primary efficacy measure of the RESERVOIR trial is the rate of fecal SARS-CoV-2 clearance (stool sample) assessed by RT-PCR, comparing the niclosamide arm to the placebo arm for up to six weeks. These long-term observation data could indicate that niclosamide treatment has the potential to improve “long haul” COVID-19 symptoms. Topline data from the study are anticipated during the first quarter of 2022.
About COVID-19 Gastrointestinal Infections
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.
There remains an urgent need to develop new medicines that can be manufactured at large scale quickly to treat COID-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.
About AzurRx BioPharma, Inc.
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
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