Interim data from a small (n=15) Phase 2a clinical trial assessing AzurRx BioPharma's (AZRX -1.3%) lead product candidate MS1819 for the treatment of exocrine pancreatic insufficiency (EPI) associated with chronic pancreatitis (CP) showed a favorable safety profile and an encouraging dose response (more than a 20% improvement in a parameter called coefficient of fat absorption or CFA) in the second or third of the four dosage levels. The study, being conducted at four sites in Australia and New Zealand, should wind up next quarter.
MS1819 is a recombinant lipase derived from the yeast Yarrowia Lipolytica. Currently, EPI patients receive enzyme replacement therapy derived from porcine (derived from pig) source material. The global market is ~$1.5B.
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