Palisade Bio, Inc. reported that the Company?s U.S. Phase 2 PROFILE study evaluating LB1148 for reduction in intra-abdominal adhesions in subjects following elective bowel resection did not achieve its primary endpoint. The Company?s U.S. Phase 2 clinical trial of LB1148 was a randomized, double-blind, placebo-controlled, parallel-group, multicenter study in patients undergoing elective bowel resection surgery. This trial was originally designed to evaluate whether patients treated with LB1148 would accelerate the return of GI function in subjects undergoing elective bowel resection with or without a planned stoma.

The study commenced in October 2019 and was paused in July 2020 due to COVID-19. During that timeframe, 79 patients were enrolled. The study was restarted in May 2022, where the protocol was amended to evaluate whether patients treated with LB1148 would experience reduction in formation of post-surgical intra-abdominal adhesions in subjects undergoing elective bowel resection with planned stoma take-down.

The study enrolled an additional 35 of the planned 70 patients under this amended protocol.