AzurRx BioPharma (NASDAQ: AZRX), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (“GI”) diseases, today announced 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 the first quarter of 2022. “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.”
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About AzurRx BioPharma Inc.
AzurRx BioPharma 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.
NOTE TO INVESTORS: The latest news and updates relating to AZRX are available in the company’s newsroom at https://ibn.fm/AZRX
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