AzurRx BioPharma (NASDAQ: AZRX), a clinical stage biopharmaceutical company specializing in the development of targeted, nonsystemic therapies for gastrointestinal (“GI”) diseases, has shared key takeaways from its topline results on its Phase 2b OPTION 2 clinical trial. The trial studied AzurRx’s drug candidate MS1819 in the treatment of cystic fibrosis (“CF”) patients with exocrine pancreatic insufficiency (“EPI”). MS1819 is a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis. The trial results were shared during a March 31, 2021, conference call hosted by AzurRx president, CEO and chair James Sapirstein and AzurRx chief medical officer Dr. James Pennington. Included in the announcements were the company’s plans to develop an optimized formulation of MS1819 for ongoing clinical investigation. “The best word to describe the OPTION 2 topline results is mixed,” said AzurRx president, CEO and chair James Sapirstein in the press release. “MS1819 demonstrated itself to be safe and well-tolerated and data from OPTION 2, and other Phase 2 clinical trials, clearly demonstrate drug activity. However, OPTION 2 did not consistently meet the primary efficacy endpoint. Some patients were able to achieve CFA at levels beyond what is required to demonstrate non-inferiority with PERT therapies, but the majority did not, and as such, we did not meet our trial goal. . . . To that end, we are planning to pursue a new formulation for MS1819, this one a capsule filled with acid-resistant granules, or microbeads, similar to what is used in CREON(R), ZENPEP(R) and other PERT therapies. Such a capsule would dissolve in the stomach, disperse the beads, and then pass through to the small intestine where the beads would break down and release the lipase enzyme so that it thoroughly mixes with food as it is being digested. We are moving full force with developing the optimal formulation technology for MS1819.”
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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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