AzurRx BioPharma Reaches Enrollment Target for Phase II OPTION Clinical Trial

AzurRX BioPharma (NASDAQ:AZRX) has announced it has reached its enrollment target of 30 to 35 patients for its ongoing Phase 2 OPTION study of MS1819-SD for exocrine pancreatic insufficiency in cystic fibrosis patients.

As quoted in the press release:

 The Company has completed screening activities for enrollment of the study, which is taking place across investigative sites in North America and Poland. Top-line results for the OPTION study are expected in Summer 2019.

The Phase II multi-center OPTION study is designed to investigate the safety, tolerability and efficacy of MS1819-SD in a head-to-head comparison against the current porcine pancreatic enzyme replacement therapy (PERT) standard of care for exocrine pancreatic insufficiency in CF patients.

Thijs Spoor, Chief Executive Officer of AzurRx, commented, “AzurRx is very pleased to report that we have reached our enrollment target of 30-35 patients that was established when the OPTION study was initiated in December 2018.  We are appreciative of the interest from the scientific community to work with patients in developing this drug, and the interest from the investment community to fund the Company as we have the resources to complete the study on schedule.”

About OPTION

The OPTION study is a Phase II, open-label, multicenter, 2×2 crossover study assessing the safety and efficacy of MS1819-SD versus porcine PERT when given at the same dose that was administered during the pre-study period.  Approximately 30 evaluable CF patients will complete both crossover periods.  The primary efficacy endpoint will be a comparison of the coefficient of fat absorption (CFAs) after each of the two crossover periods.

Click here to read the full press release.