NEW YORK, March 18, 2019 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (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:
|Presentation Title:||Results from a Multicenter, Phase II, Open-Label, Non-Randomized Study of MS1819 Spray Dried, a Recombinant Lipase for the Treatment of Exocrine Pancreatic Insufficiency in Patients with Chronic Pancreatitis|
|Presenter:||Professor Nam Q. Nguyen, Head of Education and Research, Interventional & EUS endoscopist, Royal Adelaide Hospital and Associate Professor, University of Adelaide|
|Session Title:||Clinical Chronic Pancreatitis|
|Date/Time:||Monday, May 20, 2019|
|Time:||10:00 am – 11:30 am PDT|
|Location:||Room 5 at the San Diego Convention Center|
About Phase 2 MS1819-SD in Chronic Pancreatitis
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 Company announced that it continues to dose patients in the Company's Phase II OPTION study to investigate MS1819-SD in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI).
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
MS1819-SD, supplied as an oral non-systemic biologic capsule, is a recombinant enzyme that is derived from the yarrowia lipolytica lipase, and unlike the standard of care, does not contain any animal products.
About Exocrine Pancreatic Insufficiency:
EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in the inability to digest food properly, or maldigestion. This deficiency can be responsible for greasy diarrhea, fecal urge and weight loss.
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.
AzurRx BioPharma, Inc. (AZRX) is engaged in the research and development of non-systemic biologics for the treatment of patients with gastrointestinal disorders. MS1819-SD recombinant lipase for EPI is the Company's lead development program, and additional early stage research is being conducted for the prevention of hospital-acquired infections. The Company is headquartered in Brooklyn, NY, with scientific operations based in Langlade, France. Additional information on the Company can be found at www.azurrx.com
This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company’s belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company’s control. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results, including those related to the clinical development of MS1819-SD and final results of the Phase 2 study, are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.
For more information:
AzurRx BioPharma, Inc.
760 Parkside Avenue
Brooklyn, NY 11226
Investor Relations contact:
LifeSci Advisors, LLC.
Hans Vitzthum, Managing Director
250 West 55th Street - Suite 16B
New York, NY 10019