AzurRx BioPharma Submits an Investigational New Drug Application for Niclosamide as Treatment for Grade 1 and Grade 2 Immune Checkpoint Inhibitor-Associated Colitis
AzurRx BioPharma, Inc. (AZRX)
Last azurrx biopharma, inc. earnings: 11/14 04:31 pm
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Source: GlobeNewswire
BOCA RATON, Fla., Sept. 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 the submission of an Investigational New Drug (IND) Application seeking permission from the U.S. Food and Drug Administration (FDA) to begin a clinical trial evaluating proprietary formulations of niclosamide for Grade 1 and Grade 2 colitis and diarrhea in oncology patients receiving treatment with immune checkpoint inhibitors (ICIs). The planned Phase 1b/2a clinical trial, now known as PASSPORT, is designed to determine the safety and potential efficacy of niclosamide, also known as FW-420, administered as an oral, immediate-release tablet and a topical rectal enema foam formulation. AzurRx is also currently investigating a proprietary formulation of micronized niclosamide (FW-1022) in a Phase 2 clinic
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