AzurRx BioPharma (NASDAQ: AZRX), a company specializing in the development of nonsystemic, recombinant therapies for gastrointestinal diseases, will be submitting a protocol amendment request to the U.S. Food and Drug Administration (“FDA”) for its Phase 2b OPTION 2 trial of MS1819 for the treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis. The proposed amendment requests the potential to add a study arm that uses an immediate-release MS1819 capsule. If approved, AZRX will be able to compare data from the existing arm that uses enteric (delayed-release) capsules with data from the new arm. Everything else regarding the study, including trial objectives, endpoints and statistical analysis, will remain the same. “We are pleased to announce that our OPTION 2 trial is well ahead of schedule and almost fully enrolled without any safety issues being observed,” said AzurRX chief medical officer James Pennington, MD, in the press release. “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.”
To view the full press release, visit https://nnw.fm/APyg6
About AzurRx BioPharma Inc.
AzurRx BioPharma is a biopharmaceutical company specialized in the research and development of nonsystemic 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 New York, New York, with clinical operations in Hayward, California. For more information, visit the company’s website at www.AzurRx.com.
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