Palisade Bio (NASDAQ:PALI) screened the first patient in its Phase 3 study evaluating LB1148 to accelerate the return of bowel function in adult patients undergoing gastrointestinal surgery.
“With the first U.S. clinical site open, our team is working to enroll patients as quickly as possible and expects to complete enrollment within the next 18-to-24 months,” Tom Hallam, Ph.D. and CEO of Palisade Bio, said in a statement.
“We believe that LB1148 has the opportunity to potentially establish the standard of care for millions of patients undergoing abdominal surgeries each year,” he added.
LB1148 is currently being developed for administration prior to surgeries that are at risk of disrupting the intestinal epithelial barrier.
The Phase 3 study is 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 laparoscopic surgical approaches.
The clinical study will utilize the same dosing of LB1148 used in the company’s completed Phase 2 study, where LB1148 demonstrated a 1.1-day improvement in return of bowel function.