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AzurRx BioPharma Announces Presentation on Its Positive Phase II Data in MS1819-SD in Chronic Pancreatitis at the 2019 Digestive Disease Week ConferenceNEW YORK, March 18, 2019 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that a presentation entitled “Results from a Phase II Study of MS1819, a Recombinant Lipase for the Treatment of Exocrine Pancreatic Insufficiency in Patients with Chronic Pancreatitis” authored by Dr. Nam Q. Nguyen, et al., will be delivered by Dr. Nguyen at the 2019 Digestive Disease Week (DDW) Conference being held in San Diego on May 18-21, 2019. Dr. Nguyen will discuss the positive data from the Company’s Phase II study of MS1819-SD in patients with chronic pancreatitis, which demonstrated both efficacy and dose related responses. “We are thrilled to present our positive Phase II data at this prestigious conference,” said Thijs Spoor, Chief Executive Officer of AzurRx. “We were pleased to see strong dose dependent responses along with clear clinical efficacy, which supported our decision to progress our clinical trials in both chronic pancreatitis and cystic fibrosis. We are actively enrolling patients across the US and have now initiated all eleven clinical sites in the US and expect to initiate our European sites over the next few weeks.” Mr. Spoor continued, “Our oral MS1819-SD therapy is a novel treatment for patients with gastrointestinal disorders and we are excited about the promise of our therapy and look forward to additional data readouts.” Details for the time and location of the presentation are as follows:
The Company previously reported the completion of this open-label, multi-center, dose escalation Phase IIa study, whose primary endpoint was to evaluate the safety of escalating doses of MS1819-SD in patients with chronic pancreatitis. The secondary endpoint for the study was to investigate the efficacy of MS1819-SD in these patients by analysis of the CFA and its change from baseline. The Company enrolled 11 chronic pancreatitis patients in France, Australia and New Zealand. During the course of the trial, patients “washed-out” of their standard of care treatment for EPI to establish a baseline and then were subsequently treated with escalating doses of study drug in two-week increments. Final data from the Phase IIa study show a favorable safety profile with no severe adverse events. Although the study was not powered for efficacy, in a pre-planned analysis, the highest dose cohort of MS1819-SD showed statistically significant and clinically meaningful increases in CFA compared to baseline with a mean increase of 21.8% and a p value of p=0.002 on a per protocol basis. Phase 2 MS1819-SD in Cystic Fibrosis The Phase II, open-label, multi-center, 2x2 crossover study is designed to investigate the safety, tolerability and efficacy of MS1819-SD in a head-to-head comparison against the current porcine enzyme replacement therapy (PERT) standard of care. The primary efficacy endpoint will be a comparison of CFAs after each of the two crossover periods. Planned enrollment is expected to include approximately 30 CF patients, with the results expected in mid-2019. Additional information about the ongoing OPTION MS1819-SD can be found at https://clinicaltrials.gov/ct2/show/NCT03746483?term=ms1819&rank=2 About MS1819-SD About Exocrine Pancreatic Insufficiency: There are approximately 90,000 patients in the U.S. with EPI caused by chronic pancreatitis according to the National Pancreas Foundation and more than 30,000 patients with EPI caused by cystic fibrosis according to the Cystic Fibrosis Foundation. Patients are currently treated with porcine pancreatic enzyme replacement pills. About AzurRx BioPharma, Inc. Forward-Looking Statements For more information: Investor Relations contact: |