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://ibn.fm/DVQaF
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.
NOTE TO INVESTORS: The latest news and updates relating to AZRX are available in the company’s newsroom at https://ibn.fm/AZRX
About MissionIRNewsBreaks
MissionIRNewsBreaks provide a rapid summary of corporate news that catch the attention of MissionIR. MissionIRNewsBreaks are created by our Team of professional journalists that keep a constant eye on the markets, these posts are designed to inform you on the latest happenings of our clients and other publicly traded companies on our radar. From earnings, acquisitions and agreements to conference attendance and clinical study results, our news breaks keep you up-to-date with the day’s top movers. MissionIR is primarily focused on strategic communications. We have executed countless communications programs to address the needs of companies ranging from start-ups to established industry leaders, gaining valuable experience and the expertise necessary to determine the most effective strategy for any given situation.
MissionIR (MIR)
Atlanta, Georgia
www.MissionIR.com
404.941.8975 Office
Editor@MissionIR.com
Please see full terms of use and disclaimers on the Mission Investor Relations website applicable to all content provided by MIR, wherever published or re-published: http://www.missionir.com/disclaimer.html
