AzurRx BioPharma (NASDAQ: AZRX), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (“GI”) diseases, has begun its Phase 2b OPTION 2 extension study of MS1819. AZRX announced that the first two patients have been dosed in the extension study of MS1819, which uses immediate release capsules for the treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis. MS1819 is a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis. The OPTION 2 extension phase design, which was recently announced by AzurRx, is designed to evaluate patients aged 18 years and older who have already completed the OPTION 2 crossover trial; the OPTION 2 extension study utilizes higher doses than those used in the OPTION 1 trial. The company announced that the two patients who have been dosed will continue to be treated for the duration of the next two weeks. “As expected, the Data Monitoring Committee (‘DMC’) remains supportive of our program with no safety concerns regarding the design and protocol of the study,” said AzurRx BioPharma chief medical officer Dr. James Pennington in the release. “Due to enrollment in the initial crossover trial being ahead of schedule, we are given an opportunity to thoroughly explore optimal doses and capsule types that will help guide our future development plans for MS1819 in a Phase 3 program. In the meantime, we will continue our preparation for a successful FDA meeting later this year.”
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About AzurRx BioPharma Inc.
AzurRx BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, nonsystemic therapies for gastrointestinal (“GI”) diseases. The company has a pipeline of three gut-restricted GI assets. The first is MS1819, a recombinant lipase biologic for the treatment of exocrine pancreatic insufficiency (“EPI”) in patients with cystic fibrosis and chronic pancreatitis, with two ongoing phase 2 clinical trials. The other two are clinical-stage therapies using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor: FW-420, for the treatment of grade 1 immune checkpoint inhibitor associated colitis (“ICI-AC”) and diarrhea in oncology patients, and FW-1022, for the treatment of COVID-19 gastrointestinal infections. 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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