AzurRx BioPharma (NASDAQ: AZRX), a clinical-stage biopharmaceutical company specializing in the development of targeted, nonsystemic therapies for gastrointestinal (“GI”) diseases, has announced the completion of enrollment for its phase 2b OPTION 2 clinical trial to investigate MS1819 in cystic fibrosis (“CF”) patients with exocrine pancreatic insufficiency (“EPI”). According to the announcement, the company enrolled 30 CF patients for the study, which is anticipated to return top line data by the end of Q1 2021. The upcoming phase 2b, multicenter study will investigate the safety, tolerability and efficacy of MS1819 in a head-to-head comparison against the current porcine enzyme replacement therapy (“PERT”) standard of care. MS1819 is a recombinant lipase enzyme formulated for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis. The overarching goal of the company’s MS1918 program is to offer a safe, effective therapy to control EPI and improve upon the current standard of care. MS1819 is a synthetic lipase that does not contain any animal products and offers the potential to significantly reduce the daily number of pills the current standard of care requires. “Completion of enrollment in our Phase 2b OPTION 2 trial is an important milestone in the clinical development of MS1819 as an EPI monotherapy for patients with cystic fibrosis,” said AzurRX president, chairman and CEO James Sapirstein in the press release. “Data from this trial will inform the optimal dose for a potential pivotal Phase 3 study, and we are on target to report topline results from this study at the end of the first quarter of 2021.”
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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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