CLINICAL TRIALS

A Phase 2 clinical trial has been completed in patients undergoing elective major cardiovascular surgery to evaluate LB1148 and its ability to improve return of GI function and reduce length of hospital stay. An additional investigator-sponsored trial (IST) for GI surgery (evaluating return of bowel function and postoperative adhesions) has also been completed. A Phase 2 trial of LB1148 in patients undergoing GI surgery (bowel resection) targeting both restoration of bowel function and prevention of adhesions is underway.

Cardiovascular Outcomes: Phase 2 Study

The Phase 2 clinical trial was a randomized, double-blind, parallel, placebo-controlled trial in 120 subjects undergoing coronary artery bypass grafting (CABG) and/or heart valve replacement surgery requiring cardiopulmonary bypass (CPB) with patients randomized to receive LB1148 or placebo in conjunction with surgery. LB1148 provided a 30% improvement in the time to normal bowel function following cardiovascular surgery (p<0.001) compared to placebo. This improvement resulted in a 1.1-day reduction in average length of stay in the ICU and a 1.0-day reduction in average hospital length of stay. LB1148 was also shown to be safe and well-tolerated in the study.

Postoperative Return of Bowel Function (Ileus) and Surgical Adhesions: Phase 1 Study

The clinical study was an investigator-sponsored, single-site, single arm, open label study enrolling 11 subjects undergoing GI surgery (bowel resection) with or without a stoma. Like the CV surgery study, this trial was designed to assess LB1148’s impact on recovery of GI function.

Postoperative Return of Bowel Function (Ileus) and Surgical Adhesions: Phase 2 Study

Palisade Bio has initiated a randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 2 clinical trial of LB1148 in up to 200 subjects undergoing elective bowel resection surgery in the United States and is actively enrolling patients. This trial is designed to assess LB1148’s impact on recovery of GI function, as compared to placebo. We expect to have initial data regarding the time to return of GI function from this clinical trial in the second half of 2021. The second part of this trial will evaluate whether patients treated with LB1148 also experience fewer postoperative intra-abdominal adhesions.