Why AzurRx Stock Is Trading Higher After MS1819 Combo Therapy Data?

AzurRx BioPharma Inc 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.