AZRX - AzurRx Bio soars on enrollment completion in study of MS1819 in cystic fibrosis

AzurRx BioPharma (AZRX) rise 14% premarket after completing enrollment for its Phase 2b OPTION 2 trial to investigate MS1819 in cystic fibrosis ((CF)) patients with exocrine pancreatic insufficiency.The trial enrolled 30 patients and top line data are anticipated by the end of Q1. The study is designed to investigate the safety, tolerability and efficacy of MS1819 in enteric capsules in comparison against the current porcine enzyme replacement therapy standard of care.The primary efficacy endpoint is the coefficient of fat absorption, with secondary endpoints of stool weight, signs and symptoms of malabsorption and coefficient of nitrogen absorption.The trial also includes an extension arm that uses an immediate release MS1819 capsule.Data from this trial will inform the optimal dose for Phase 3 study.

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AzurRx Bio soars on enrollment completion in study of MS1819 in cystic fibrosis