NEW YORK, April 23, 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 it has now surpassed the 50% enrollment target in its ongoing Phase II OPTION study of MS1819-SD for exocrine pancreatic insufficiency in patients with cystic fibrosis (CF).
The Phase II multi-center OPTION study is designed to investigate the safety, tolerability and efficacy of MS1819-SD in a head-to-head comparison against the current porcine pancreatic enzyme replacement therapy (PERT) standard of care for exocrine pancreatic insufficiency in CF patients. Planned enrollment is expected to include approximately 30 CF patients, with top-line results expected in Summer 2019.
Thijs Spoor, Chief Executive Officer of AzurRx, commented, “The AzurRx team is very pleased to have reached the half-way mark of enrollment in our OPTION study of MS1819-SD. This represents an important milestone for AzurRx and demonstrates that we are on track to complete enrollment by mid-2019. Once again, we would like to thank both the participating patients and our clinical collaborators for insuring successful study progression.”
About OPTION
The OPTION study is a Phase II, open-label, multicenter, 2x2 crossover study assessing the safety and efficacy of MS1819-SD versus porcine PERT when given at the same dose that was administered during the pre-study period. Approximately 30 evaluable CF patients will complete both crossover periods. The primary efficacy endpoint will be a comparison of the coefficient of fat absorption (CFAs) after each of the two crossover periods.
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
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):
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 CF according to the Cystic Fibrosis Foundation. Patients are currently treated with porcine pancreatic enzyme replacement pills.
AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: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.