AzurRx’s Phase II OPTION study of MS1819-SD achieves enrollment target

It has reached the enrollment target of 30-35 patients that was determined when the OPTION study was started in December 2018

AzurRx BioPharma has recently confirmed that it has achieved its enrollment target of 30-35 patients in the ongoing Phase II OPTION study of MS1819-SD in cystic fibrosis (CF) patients, for exocrine pancreatic insufficiency. The company reportedly specializes in the development of recombinant, non-systemic therapies for gastrointestinal diseases.

Seemingly, AzurRx BioPharma has completed its screening activities for enrollment of the study, which is rolling out across investigative sites in Poland and North America. Top-line results for the OPTION study are anticipated in Summer 2019.

Sources familiar with the matter informed that the Phase II multi-center OPTION clinical trial is formally designed to examine the efficacy, tolerability, and safety of MS1819-SD by comparing it head-to-head against the present porcine pancreatic enzyme replacement therapy with standard of care for exocrine pancreatic insufficiency in patients with CF.  

According to Chief Executive Officer of AzurRx, Thijs Spoor, the company has reached the enrollment target of 30-35 patients that was determined when the OPTION study was started in December 2018.

Apparently, the OPTION study is a Phase II, multicenter, open-label, and 2x2 crossover study evaluating the efficacy and safety of MS1819-SD against porcine PERT when given the same dosage during the period of pre-study. Both crossover periods will be completed by around 30 evaluable CF patients. The primary efficacy endpoint would involve comparing the coefficient of fat absorption (CFAs) following both the crossover stages.

For the uninitiated, AzurRx BioPharma is involved in the R&D of non-systemic biologics for treating patients experiencing gastrointestinal disorders. MS1819-SD recombinant lipase is the lead development program of the company. Along with this, an additional early stage research is being performed for preventing hospital-acquired infections. The headquarter of the company is in Brooklyn, NY and it has scientific operations located in Langlade, France. 

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