First Wave BioPharma, a clinical-stage biopharmaceutical company specializing in gastrointestinal (GI) diseases, has announced that the final patient has been dosed in the Phase 2 SPAN clinical trial. The trial is investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in cystic fibrosis (CF) patients. Topline data from the study is expected to be released in July 2023.
The Phase 2 SPAN clinical trial, registered as NCT05719311, aims to evaluate the safety, tolerability, and efficacy of an enteric microgranule delivery formulation for adrulipase. Thirteen patients are involved in this titrated dose-escalation study. The primary efficacy endpoint is the coefficient of fat absorption (CFA), with secondary endpoints including stool weight, signs and symptoms of malabsorption, and coefficient of nitrogen absorption (CNA). The results are anticipated by mid-2023.
James Sapirstein, President and CEO of First Wave BioPharma, stated that dos