BROOKLYN, NY, USA I September 27, 2017 I AzurRx BioPharma Inc.(NASDAQ:AZRX) (“AzurRx” or the “Company”), today provided an update on the first six treated patients in its ongoing Phase IIa trial of MS1819-SD, a recombinant lipase, for the treatment of exocrine pancreatic insufficiency (EPI) caused by chronic pancreatitis.
Importantly, the company observed both clinical activity and a clear dose response, where the highest MS1819-SD dose cohort showed greater than 21% improvement in CFA (coefficient of fat absorption) in evaluable patients. Additionally, maximal absolute CFA response to treatment was up to 57%, with an inverse relationship to baseline CFA. Favorable trends were also observed on other evaluated endpoints, such as Bristol stoolhttp://boulderpeptide.org/2017/09/27/azurrx-biopharma…data-in-exocrine/ scale, number of daily evacuations and weight of stool, and these were consistent with the CFA results.
With regard to safety, no serious adverse events or notable mild to moderate events have been reported in the open-label, ascending dose Phase IIa trial. Other markers relating to nutritional status including patients’ plasma albumen were unchanged with treatment. Similarly, fecal nitrogen assessments showed favorable trends.
“We are encouraged by these Phase IIa data,” said Thijs Spoor, CEO of AzurRx BioPharma. “They further confirm the activity of MS1819-SD and also demonstrate its dose response characteristics. Additionally, secondary efficacy endpoints are consistently aligning with the CFA data and the safety profile of MS1819-SD remains favorable.”
Phase IIa Study
The open-label, dose escalation Phase IIa study is being conducted in Australia and New Zealand and has been designed to enroll 12-15 patients with EPI caused by chronic pancreatitis.
The primary objective of the Phase IIa 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. Safety is being assessed at the end of each treatment period with particular attention paid to immunoallergic effects, digestive symptoms and clinical laboratory tests.