• AzurRx BioPharma Inc (NASDAQ: AZRX) has announced topline results from its Phase 2 Combination Trial evaluating MS1819 with porcine-derived pancreatic enzyme replacement therapy (PERT) for severe exocrine pancreatic insufficiency in cystic fibrosis (CF) patients.
• Data collected from 20 patients indicated that MS1819 in combination with PERT led to clinically meaningful improvements in the primary efficacy endpoint, the Coefficient of Fat Absorption (CFA). 
• Patients showed an average gain of more than six percentage points from baseline, compared to the five-point improvement in CFA cited by the clinical literature.
• The study also demonstrated positive improvements in weight gain and other secondary endpoints.
• Related: AzurRx BioPharma Stock Gains On Positive Interim Data Of MS1819-PERT Combo In Pancreatic Insufficiency.
• From baseline, CFA increased by 6.57%, mean body weight increased by 3.75 pounds, stool weight decreased by 164 grams/day, and the mean daily number of stools decreased by 0.43. 
• AzurRx is now developing a new enteric-coated microbead formulation for MS1819 and plans to initiate a bridging study in 2022 evaluating the formulation as a single-agent therapy. 
• Formulation work is expected to be completed by the end of 2021.
• MS1819 is a recombinant lipase enzyme.
• Price Action: AZRX shares are up 45.4% at $0.76 during the premarket session on the last check Wednesday.

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