Palisade Bio Announces Topline Results from U.S. Phase 2 PROFILE Study Evaluating LB1148 for Post-Surgical Abdominal Adhesions

– Study did not achieve primary efficacy endpoint of reducing adhesions in LB1148 treated patients compared to placebo treated patients post bowel resection surgery

Excerpt from the Press Release:

Carlsbad, CA, Aug. 09, 2023 (GLOBE NEWSWIRE) — Palisade Bio (Nasdaq: PALI), a biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, today 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.

“First and foremost, I would like to extend our appreciation to all of the study participants, the clinical staff at the study sites, as well as our team. The PROFILE study has provided us with a definitive outcome and enabled us to quickly make the decision to no longer pursue the adhesions indication,” commented J.D. Finley, Chief Executive Officer of Palisade Bio. “Moving forward, we remain committed to the future of Palisade and are in the midst of encouraging discussions that we believe will lead to pipeline expansion opportunities in high value indications in the GI space. Our focus is now on completing these discussions in order to unlock opportunities and provide value for our shareholders.”

PROFILE Study Design

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.

Primary Endpoint

Of the patients enrolled as of May 10, 2023, 31 patients completed a first surgery, and 22 patients completed a second surgery, which is required to evaluate the primary endpoint.

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