Palisade Bio (NASDAQ:PALI) dosed the first patient in its Phase 3 study evaluating LB1148 to accelerate the return of bowel function in adult patients undergoing gastrointestinal surgery.
“With what we believe to be a pivotal Phase 3 study now fully underway, we are focused on building momentum and completing enrollment as quickly and efficiently as possible,” Tom Hallam, Ph.D. and CEO of Palisade Bio, said in a statement.
“The design of the Phase 3 study mirrors that of our positive Phase 2 study where LB1148 demonstrated a statistically significant improvement [of 1.1 days] in the time of return of bowel function,” he added.
The Phase 3 study is designed as a multi-center, randomized, double-blind, parallel-group, placebo-controlled clinical trial set to enroll approximately 600 patients, which will assess the safety and efficacy of LB1148. All patients enrolled in the study will undergo a scheduled bowel resection surgery that will include either laparotomy or minimally invasive surgical approaches.
