Palisade Bio, Inc. (NASDAQ:PALI), and co-development partner Newsoara today announce completion of a Phase 2 clinical trial evaluating lead drug candidate LB1148 for accelerating return of bowel function associated with gastrointestinal (GI) surgery. The PROFILE study in China is a randomized, double-blind, multicenter, Phase 2 trial that has enrolled over 120 patients undergoing elective bowel resection. Patients received an oral dose of LB1148 prior to surgery. The primary endpoint of clinical efficacy is the time to return of bowel function.
“Completing the PROFILE study in China is a significant milestone for Palisade Bio in our mission to bring innovative treatments to the millions of people undergoing gastrointestinal surgery across the globe. We eagerly look forward to results from this trial,” said Tom Hallam, Ph.D., CEO of Palisade Bio. “We are thankful for the unwavering commitment, support, and enthusiasm of our co-development partner Newsoara, the investigators and clinicians involved in executing this trial and are incredibly grateful to the patients who volunteered to participate in the study. We hope the data from this trial build on the early efficacy signals observed in a previous clinical study in GI surgery. Positive data would be a transformative milestone to help advance LB1148 towards eventual approval for surgical indications.”
Dr. Benny Li, CEO of Newsoara, added, “We are maintaining focus on high quality trial conduct over the course of the study. New treatment options for accelerating the return of bowel function after surgery are desperately needed. We believe LB1148 has the potential to improve the return of GI function for patients undergoing GI surgery to address this significant unmet need. By completing this study, we have achieved the next milestone on our path to potentially delivering LB1148 as the first therapy indicated for accelerating return of bowel function in China.”
Previously Palisade Bio described statistically significant data from the Phase 1, single-site, open-label, investigator-sponsored trial, called LBS-IST-POI-101, that enrolled 11 and evaluated 10 patients at a hospital in the United States. The trial evaluated the use of LB1148 for safety and preliminary efficacy in subjects undergoing elective bowel resection. LB1148 treated patients had a statistically significant reduction in hospital length of stay by 1.3-days when compared with expected length of stay based on their billing code at admission.