Palisade Bio expects data readout from Phase 2 study of LB1148 in 1H23

Palisade Bio is providing an update on its U.S. Phase 2 study evaluating LB1148 for reduction in intra-abdominal adhesions in subjects following elective bowel resection The Company enrolled a total of 35 of the planned 70 patients in its Phase 2 study. Of the patients enrolled, 31 have completed their first surgery, and nine have completed a second surgery, which is an inflection point for data under the current study protocol. Palisade believes that the data collected to date is sufficient for its evaluation purposes, including an evaluation of its risk profile, and for such reason, the Company is voluntarily ceasing enrollment in the trial. Palisade expects to report topline data from the 35 patients in the first half of 2023. The Company is currently designing a dose optimization study for all indications to determine if a different dosing protocol would enhance the risk profile while simultaneously providing efficacy. It is anticipated that this study will generate pharmacokinetic and pharmacodynamic data across multiple doses in patients, with enrollment expected to commence in the first half of 2023. The Company’s U.S. Phase 2 clinical trial of LB1148 is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study in patients undergoing elective bowel resection surgery. This trial is designed to evaluate whether patients treated with LB1148 experience reduction in formation of post-surgical intra-abdominal adhesions and accelerate the return of GI function in subjects undergoing elective bowel resection with planned stoma take-down.