AzurRx BioPharma (NASDAQ: AZRX), a company specializing in the development of nonsystemic, recombinant therapies for gastrointestinal diseases, has added two clinical trial sites for the extension arm of its MS1819 Phase 2b OPTION 2 study. The study is investigating immediate-release capsules of MS1819 for the treatment of exocrine pancreatic insufficiency (“EPI”) in patients with cystic fibrosis (“CF”). The additional sites were added in Poland; Europe was selected to reduce potential patient-enrollment delays caused by the COVID-19 pandemic. The two sites in Poland and the active clinical trial sites in the United States have already begun enrolling patients. AzurRX expects topline data to be available this quarter. “MS1819 has the potential to redefine the treatment of exocrine pancreatic insufficiency, a debilitating gastrointestinal condition common to patients with cystic fibrosis that can lead to a chronic nutritional deficiency,” said AzurRX president and CEO James Sapirstein in the press release. “The goal of the MS1819 program is to provide cystic fibrosis patients with a safe and effective therapy that enables them to control EPI and achieve the nutrition necessary for healthy growth, weight maintenance, and good lung function. The recently initiated extension arm to the Phase 2b OPTION 2 trial provides the opportunity to investigate an immediate-release capsule formulation of MS1819, which we believe could offer important advantages to cystic fibrosis patients in their daily management of EPI. Overall, the OPTION 2 trial of MS1819 is proceeding ahead of schedule, and we look forward to reporting topline data in 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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