Phase 3 study of LB1148 in lead indication for postoperative return of bowel function on track to commence Q2 2022
CARLSBAD, Calif., May 02, 2022 (GLOBE NEWSWIRE) -- Palisade Bio (Nasdaq: PALI), a clinical stage biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, today provided a business outlook and outlined its expected near-term pipeline advancements.
“The positive data we have amassed continues to support our development strategy and provides us with confidence as we advance our lead program into a Phase 3 study this quarter. Each day that a patient remains in the hospital can cost upwards of approximately $2,400, representing a significant burden on the cost of healthcare. We believe, if approved, LB1148 will protect gastrointestinal integrity and accelerate the return of postoperative GI function, providing hospitals with a potentially safe solution to accelerate patient discharge. Additionally, LB1148 has the potential to reduce abdominal adhesions – a problem that can cause an alarming number of post-surgery complications. With our data in hand, we have aligned on a strategy for LB1148 to transform the current standard of care which will allow us to unlock significant value for our shareholders,” commented Tom Hallam, Ph.D., Chief Executive Officer of Palisade Bio.
Clinical Program Update
LB1148: oral formulation of a broad-spectrum serine protease inhibitor designed to neutralize the activity of potent digestive proteases released from the gut during surgery
LB1148 is a novel oral liquid formulation of the well-characterized digestive enzyme inhibitor, tranexamic acid (“TXA”), with potential to both reduce abdominal adhesions and help restore bowel function following surgery. The therapy is being developed for administration prior to major surgeries that are at risk of disrupting the intestinal epithelial barrier. Evidence suggests that the release of digestive proteases contributes to the temporary loss of normal gastrointestinal function and the formation of postoperative adhesions. By inhibiting the activity of these digestive proteases, LB1148 has the potential to prevent damage to GI tissues, accelerate the time to the return of normal GI function, and shorten the duration of costly post-surgery hospital stays.
Postoperative Return of Bowel Function: GI Surgery
In March 2022, the Company received a “Study May Proceed” letter from the U.S. Food and Drug Administration (FDA) to initiate its Phase 3 clinical trial evaluating LB1148 to accelerate the return of bowel function in adult patients undergoing bowel/abdominal surgery. The trial is designed as a multi-centered, randomized, double-blinded, parallel-group, placebo-controlled clinical trial set to enroll approximately 600 patients, and will assess the safety and efficacy of LB1148. All patients enrolled in the trial will undergo a scheduled bowel resection surgery that will include either laparotomy or laparoscopic surgical approaches.
The expected timelines are management’s current forecasts and will be updated as enrollment progresses.
Expected Upcoming Milestones
- Q2 2022: Phase 3 study initiation
- 2H 2022: Phase 3 study first patient enrolled
Prevention of Post-Surgical Abdominal Adhesions: GI Surgery
Digestive enzymes can escape the intestine during major surgery and cause damage to the intestines and surrounding organs resulting in the formation of scar tissue known as adhesions. Adhesion prevalence has historically reported to be >90% in patients who undergo abdominal surgery and represents a potentially significant contribution to serious complications. Adhesions can be the cause of chronic pain and may prevent normal organ function, including bowel obstructions of the intestine. Adhesions can increase the difficulty of subsequent surgeries causing complications and are the leading cause of secondary infertility in women. In some cases, adhesions require a second corrective surgical procedure. There are currently no approved medications to prevent or treat adhesions.
Previously the Company had just three patients who had been assessed for adhesions following GI surgery. In the Company’s recent data presentation at the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) 2022 Annual Meeting, a pooled-study analysis of 17 patients demonstrated LB1148 reduced incidence of adhesions by 72% and reduced the extent and severity of adhesions by 93% in patients undergoing bowel resection.
The Company is conducting an ongoing randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 2 clinical trial of LB1148 in up to 200 patients undergoing elective bowel resection surgery in the United States. This trial is designed to evaluate whether patients treated with LB1148 experience fewer postoperative intra-abdominal adhesions. The trial will also assess LB1148’s impact on recovery of GI function, as compared to placebo.
Expected Upcoming Milestones
- Q4 2022: Phase 2 enrollment completion
- 1H 2023: Phase 2 study completion
- 2H 2023: Report Phase 2 topline results
Postoperative Return of Bowel Function: Cardiovascular Surgery
The Company previously announced positive topline data from its Phase 2 study demonstrating LB1148 achieved its primary endpoint with statistically significant improvement in bowel function following cardiovascular surgery. The Phase 2 clinical trial was a randomized, double-blind, parallel, placebo-controlled trial in 120 subjects undergoing coronary artery bypass grafting (CABG) and/or heart valve replacement surgery requiring cardiopulmonary bypass (CPB) with patients randomized to receive LB1148 or placebo in conjunction with surgery. LB1148 provided a 30% improvement in the time to normal bowel function following cardiovascular surgery (p