Palisade Bio (NASDAQ:PALI) received a “study may proceed” letter from the FDA for a Phase 3 clinical trial to evaluate LB1148 to accelerate the return of bowel function in adult patients undergoing bowel/abdominal surgery.
The trial is designed as a global, multi-centered, randomized, double-blinded, parallel-group, placebo-controlled clinical trial enrolling approximately 600 subjects, and will assess the safety and efficacy of LB1148.
All patients enrolled in the trial will be undergoing a scheduled bowel resection surgery that will include either laparotomy or laparoscopic surgical approaches. Palisade Bio intends to initiate the Phase 3 clinical trial in the second half of 2022.
In two separate Phase 2 trials – one in cardiovascular surgery patients and one in GI surgery patients – LB1148 demonstrated statistically significant acceleration of return of GI function.
“We are optimistic that our Phase 3 clinical trial will reaffirm these findings and, if successful, will lead to this product being available to patients who could benefit from it,” Tom Hallam, Ph.D. and CEO of Palisade, said in a statement.
Michael Dawson, M.D. and CMO of Palisade Bio, said LB1148 could simplify healing from the almost seven million surgeries each year in the U.S. where patients are at risk for postoperative ileus. “A quicker return to bowel function means patients recover faster, while potentially reducing costs to the healthcare system.”
