AzurRx BioPharma (NASDAQ: AZRX), a clinical-stage biopharmaceutical company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, recently submitted a protocol amendment request to the U.S. Food and Drug Administration (“FDA”). Approval of the amendment will allow AzurRx to modify its current Phase 2b OPTION 2 trial of MS1819 in cystic fibrosis (“CF”) patients to add a study arm that uses immediate release capsules (https://ibn.fm/SxH8F). The existing study arm uses delayed release capsules, so the expansion will allow AzurRx to compare data from both arms to determine the best delivery method for its lead product, an exocrine pancreatic insufficiency drug candidate. An article discussing this quotes AzurRx Chief Medical Officer Dr. James Pennington, who stated, “As this trial progresses, we believe there may be significant clinical value in adding a study arm that uses our immediate release capsules. Our intention is to identify the optimal delivery method and potentially provide additional scientific support and optionality for MS1819.”
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About AzurRx BioPharma Inc.
AzurRx BioPharma is a biopharmaceutical company specializing in the research and development of non-systemic biologics for gastrointestinal disorders. The company is focused on the development of its lead drug candidate, MS1819. AzurRx is currently conducting two Phase 2 clinical trials of MS1819: the OPTION 2 monotherapy trial and the combination therapy trial consisting of MS1819 in conjunction with porcine-derived pancreatic enzyme replacement therapy, the current standard of care. The company is headquartered in Delray Beach, Florida, with clinical operations in Hayward, California. For more information, visit the company’s website at www.AzurRx.com.
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