Palisade Bio Inc (NASDAQ: PALI) has announced the dosing of the first patient in the third phase LB1148 assessment to accelerate bowel function restoration in adults undergoing gastrointestinal surgery.
Palisade does first patients in LB1148 Phase 3 study
The company’s CEO, Tom Hallam, commented, “The dosing of our first patient in the LB1148 Phase 3 marks a noteworthy milestone for the company and another important step forward in the execution of our strategy. With what we believe to be a pivotal Phase 3 study now fully underway, we are focused on building momentum and completing enrolment as quickly and efficiently as possible.”
The Phase 3 study’s methodology is similar to our successful Phase 2 study, in which LB1148 showed a statistically meaningful reduction in the time it took for the gastrointestinal function to return.
LB1148 is the company’s flagship product candidate that is currently under development. It is a proprietary oral liquid formula containing the well-known digestive enzyme inhibitor tranexamic acid. Interestingly it has the capability to both lessen abdominal scar tissue and assist in restoring bowel function after surgery. LB1148 is being created right now to be given before operations that could damage the intestinal epithelial membrane.
LB1148 promises to be SoC for expediting postoperative bowel function return
The study’s principal investigator Dr. Soghomonyan stated, “LB1148 represents a promising opportunity to establish the standard of care for accelerating the postoperative return of bowel function. In my opinion, the data with LB1148 to date is encouraging and provides a solid foundation as we begin to dose patients in this phase of development.”
A total of 600 participants will be included in the Phase 3 trial, a randomized, multicenter, double-blind, placebo-controlled, parallel-group clinical trial that will evaluate the safety and effectiveness of LB1148. The study’s primary objective will be the recovery duration of the gastrointestinal (upper & lower) tract after surgery as defined at the end of the operation relative to food tolerance and first bowel movement. In addition, all study participants will have a scheduled colon resection procedure that will either involve a laparotomy or less invasive surgical techniques.