First Wave BioPharma exceeds 50% enrollment target for Phase 2 SPAN trial

First Wave BioPharma announced that it has now surpassed the 50% enrollment target in its ongoing Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency, EPI, in patients with cystic fibrosis, CF. The Phase 2 multi-center clinical trial is designed to investigate the safety, tolerability and efficacy of an enteric microgranule delivery formulation for adrulipase in a titrated dose-escalation study involving an estimated twelve patients. 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. Topline results from the study are anticipated by mid-2023. James Sapirstein, Chief Executive Officer of First Wave BioPharma, commented, "We are very pleased to have reached the half-way mark of enrollment in our SPAN study of adrulipase. This represents an important milestone for First Wave and demonstrates that we are on track to complete enrollment in 1H’23 and report topline data in July 2023. Once again, we would like to thank both the participating patients and our clinical collaborators for ensuring successful study progression."