AzurRx: 1st patient dosed in Phase 2 cystic fibrosis trial

AzurRx BioPharma, Inc. (NASDAQ: AZRX) today provided a clinical development and strategic corporate update.Clinical DevelopmentThe Company announced that it has dosed the first patients in the Company’s Phase II OPTION study to investigate MS1819-SD in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (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 the results expected in mid-2019. Key highlights of OPTION include:

• Primary endpoint is a six-week non-inferiority, coefficient of fat absorption (CFA) assessment comparing MS1819-SD to the standard of care porcine pancreatic enzyme replacement therapy (PERT) in patients with exocrine pancreatic insufficiency due to cystic fibrosis;
• Cross-over study design leverages input from the U.S. Food and Drug Administration (FDA) and the CF community;
• Target enrollment of approximately 30 patients 18 years of age and older; and
• Top-line results expected mid-2019.

https://www.streetinsider.com/Corporate+News/AzurRx+BioPharma+%28AZRX%29+Reports+First+Patients+Dosed+in+Phase+II+OPTION+Clinical+Trial/15155387.html