AzurRx BioPharma Stock Gains On Positive MS1819-PERT Combo Data In Pancreatic Insufficiency

AzurRx BioPharma Inc AZRX announced positive interim data from the first 18 out of 20 patients from its Phase 2 trial. The study was evaluating MS1819 in combination with the current standard of care, porcine-derived pancreatic enzyme replacement therapy (PERT), for severe exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF).
The interim data revealed that the combination therapy led to clinically meaningful improvements in the primary efficacy endpoint, the Coefficient of Fat Absorption (CFA), with an average gain of 5.9 points from baseline, over the six-week trial.
"It is also very encouraging to note that all the patients responded well and that many reported that they felt better overall when MS1819 was added to their daily dose of PERT", said Dr. James Pennington, Chief Medical Officer.
Full topline results from all 20 patients enrolled in the trial are expected in the second quarter of 2021.
MS1819 is a recombinant lipase enzyme supplied as an oral, non-systemic, biologic capsule derived from the Yarrowia lipolytica yeast lipase.
It breaks up fat molecules in the digestive tract of EPI patients to be absorbed as nutrients.
Price Action: AZRX shares are trading 8.9% higher at $0.79 during the premarket session on the last check Thursday.