EPI - AzurRx starts dosing in mid-stage cystic fibrosis study of MS1819

AzurRx BioPharma (AZRX) announces that the first two patients have been dosed in the Phase 2b OPTION 2 extension study of MS1819 using immediate release capsules for the treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis.The OPTION 2 extension phase design will test patients 18 years or older, who have already completed the crossover trial, at higher doses relative to the previously conducted OPTION 1 trial.MS1819 is a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis.Topline data results for this study are expected in Q1 2021.AzurRx had activated two trial sites in Turkey for its Phase 2 trial, evaluating MS1819 combined with porcine pancreatic enzyme replacement therapy (PERT), in cystic fibrosis (CF) patients with severe exocrine pancreatic insufficiency (EPI) in October last year.AzurRx shares up ~5% premarket.

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AzurRx starts dosing in mid-stage cystic fibrosis study of MS1819