First patient enrolled and dosed in pivotal phase III study evaluating LB 1148 for post -operative return of bowel function
Palisade Bio, Inc. announced the first patient has been dosed in its Phase III study evaluating LB 1148 to accelerate the return of bowel function in adult patients undergoing gastrointestinal surgery
The Phase III 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 LB 1148. 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 laparotomy or minimally invasive surgical approaches. The clinical study will utilize the same dosing of LB 1148 used in the company’s completed Phase II study in which LB 1148 demonstrated a 1.1-day improvement in return of bowel function.
LB 1148, 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. LB 1148 is currently being developed for administration prior to surgeries that are at risk of disrupting the intestinal epithelial barrier.
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