Palisade Bio (NASDAQ:PALI) initiated a Phase 3 study evaluating LB1148 to accelerate the return of bowel function in adult patients undergoing gastrointestinal surgery. The first clinical site in the U.S. is now open.
“If approved, we believe LB1148 has the potential to be established as the standard of care for millions of patients undergoing abdominal surgeries each year,” Tom Hallam, Ph.D. and CEO of Palisade Bio, said in a statement.
LB1148 is currently being developed for administration prior to surgeries that are at risk of disrupting the intestinal epithelial barrier.
The multi-center, randomized, double-blind, parallel-group, placebo-controlled Phase 3 clinical trial set to enroll approximately 600 patients, which will assess the safety and efficacy of LB1148.
The primary endpoint is time to recovery of the upper and lower gastrointestinal tract following surgery, defined as the time from the end of surgery to the toleration of food and first bowel movement.
All patients enrolled in the study will undergo a scheduled bowel resection surgery that will include either a laparotomy or laparoscopic procedure. The clinical study will utilize the same dosing protocol used in the company’s completed Phase 2 study that demonstrated a 1.1-day improvement in return of bowel function.
Based on management’s current study projections and timelines, enrollment is targeted for completion within 18-to-24 months.
LB1148, the company’s lead asset in development, is a novel oral liquid formulation of the well-characterized digestive enzyme inhibitor tranexamic acid, with the potential to both reduce abdominal adhesions and help restore bowel function following surgery.
