AzurRx BioPharma (NASDAQ: AZRX), a clinical-stage biopharmaceutical company, recently announced positive results from the first five patients in its Phase 2 combination therapy trial of MS1819 for the treatment of severe exocrine pancreatic insufficiency (“EPI”) in patients with cystic fibrosis (“CF”). In the primary efficacy analysis, patients receiving MS1819 in combination with PERT therapy achieved a clinically meaningful improvement in the coefficient of fat absorption (“CFA”) at each of the three dose levels. No adverse safety events were reported and, additionally, patients showed improvements in the key secondary endpoints, including body weight, stool consistency and reductions in the number of bowel movements and the incidence of steatorrhea. “We are thrilled to see such consistently positive responses from these initial patients in our ongoing Phase 2 combination therapy trial with MS1819. EPI is a very challenging disease with many CF patients unable to achieve healthy nutrition even when using the maximum number of allowed or tolerated PERT capsules, especially those in the moderate-severe categories,” AzurRx CEO James Sapirstein said of the results. “We look forward to completing treatment of all patients and announcing top line data in 2021.”
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About AzurRx BioPharma Inc.
AzurRx BioPharma is a biopharmaceutical company specializing 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, NY, with scientific operations based in Langlade, France, and clinical operations in Hayward, California. For more information about the company, visit www.AzurRx.com.
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