There are approximately 100,000 patients in the U.S. with EPI caused by CP 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.
BROOKLYN, N.Y., 17 NOV. 2016 (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, announced today that in partnership with Mayoly Spindler, a European pharmaceutical company, the initiation of a Phase II clinical trial evaluating the safety and efficacy of MS1819-SD in patients with exocrine pancreatic insufficiency (EPI) caused by chronic pancreatitis (CP).
The open-label, dose escalation Phase II study is being conducted in two sites in Australia
The Royal Adelaide Hospital and Linear Clinical Research in Perth as well as two sites in New Zealand, P3 Research in Wellington and CCST in Christchurch. The study is projected to enroll approximately 12 patients with EPI caused by chronic pancreatitis over the next several months. Dr. Quoc Nam Ngyuen, Associate Professor in the Department of Gastroenterology at the Royal Adelaide Hospital is the principal investigator for the study.
The primary objective of this Phase II study is to investigate the safety of escalating doses of MS1819-SD in patients with chronic pancreatitis. The secondary objective is to investigate the efficacy of MS1819-SD in these patients by analysis of the coefficient of fat absorption and its change from baseline. Initial study results from the MS1819-SD Phase II study are expected in the first half of 2017.