First Wave BioPharma announces initial results from Phase 2 SPAN trial

First Wave BioPharma announced the Company has received topline results from the Company’s Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis. Initial data from the study indicate the enhanced adrulipase formulation was safe and well tolerated and demonstrated an improvement over prior formulations of adrulipase. However, the preliminary data also indicate that it is likely the primary efficacy endpoint was not achieved. “Preliminary data from the Phase 2 SPAN clinical trial indicate our enhanced microgranule delivery formulation of adrulipase was safe and well tolerated,” said James Sapirstein, President and CEO of First Wave BioPharma. “We are in the process of analyzing the dataset and anticipate having a topline review of the primary and secondary endpoints in the September timeframe.” Mr. Sapirstein added: “We would like to thank the patients who volunteered to participate in the study and the investigators and their staff at our three participating clinical trial sites for ensuring that the trial was fully enrolled and completed on time.”