AzurRx BioPharma and Mayoly-Spindler Announce Additional Positive Interim Data for MS1819-SD Phase II

AzurRx BioPharma (NASDAQ:AZRX) today provided an update on the first nine 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.

As quoted in the press release:

The Company observed both clinical activity and a clear dose response, where the highest MS1819-SD dose cohort continued to show 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 stool 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 and nitrogen output showed favorable trends.”

Click here to read the full press release.