AzurRx BioPharma initiates Phase 2 OPTION study
AzurRx BioPharma announced that it has initiated the company's Phase II OPTION study to investigate MS1819-SD in cystic fibrosis, or CF, patients with exocrine pancreatic insufficiency, or EPI. The Phase II multi-center study is designed to investigate the safety, tolerability and efficacy of MS1819-SD in a head-to-head comparison against the current porcine enzyme replacement therapy standard of care. Planned enrollment is expected to include approximately 30 CF patients, with study completion anticipated in 2019. The study has a six-week non-inferiority, coefficient of fat absorption, or CFA, primary endpoint comparing MS1819-SD to porcine enzyme replacement therapy in patients with exocrine pancreatic insufficiency due to cystic fibrosis.