AzurRx BioPharma (NASDAQ: AZRX), a company specializing in the development of nonsystemic, recombinant therapies for gastrointestinal diseases, announced that it has completed patient enrollment in the first cohort of its Phase 2b OPTION 2 extension study. The study is evaluating immediate-release capsules of MS1819 for the treatment of exocrine pancreatic insufficiency (“EPI”) in patients with cystic fibrosis (“CF”). In the announcement, the company noted that the Phase 2b OPTION 2 trial extension arm is dosing patients at sites in the United States and Europe; patients in this study previously participated in arms of the OPTION 2 trial. The ultimate objective of the MS1819 program is to offer cystic fibrosis patients a safe and effective treatment to control EPI, a debilitating gastrointestinal condition common in patients with cystic fibrosis; the condition can lead to a chronic nutritional deficiency. AZRX’s MS1819 is a recombinant lipase enzyme designed for the treatment of EPI associated with cystic fibrosis and chronic pancreatitis. “The extension arm of the Phase 2b OPTION 2 trial is providing us with an opportunity to determine both the optimized dosage and delivery mechanism of MS1819,” said AzurRx BioPharma president and CEO James Sapirstein in the press release. “We have fully enrolled the most important cohort of the extension study and would like to thank both our clinical collaborators and patients for their continued participation in the study. We continue to be encouraged by the absence of any reports of serious adverse events to date, and eagerly look forward to reporting topline results from this trial in Q1 2021.”
To view the full press release, visit https://ibn.fm/8ePYT
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.
NOTE TO INVESTORS: The latest news and updates relating to AZRX are available in the company’s newsroom at https://ibn.fm/AZRX
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