Phase 3 study of LB1148 in lead indication for postoperative return of bowel function on track to commence Q2 2022
Ongoing Phase 2 study of LB1148 for the prevention of post-surgical abdominal adhesions
CARLSBAD, Calif., May 13, 2022 (GLOBE NEWSWIRE) -- Palisade Bio (Nasdaq: PALI), a clinical stage biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, today reported its financial results for the quarter ended March 31, 2022.
Additionally, the Company provided a clinical program update for its lead asset in development, LB1148, an oral formulation of a broad-spectrum serine protease inhibitor designed to neutralize the activity of potent digestive proteases released from the gut during surgery.
Recent Highlights
- Extended cash runway with a $2.0 million registered direct offering.
- Received National Medical Products Administration (NMPA) clearance to commence Phase 3 clinical trial in China evaluating LB1148 to accelerate the return of bowel function following abdominal surgery.
- Received “Study May Proceed” letter from the U.S. Food and Drug Administration (FDA) for Phase 3 clinical trial evaluating LB1148 to accelerate the return of bowel function following abdominal surgery.
- Presented data from a pooled-analysis of studies LBS-IST-POI-101 and LBS-POI-201-CN (PROFILE-CN) demonstrating LB1148 reduced the extent and severity of post-surgical intraabdominal adhesions by 93% at the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) 2022 Annual Meeting.
- Appointed Robert McRae as Senior Vice President, Operations and Strategic Development.
“We have made exciting progress on the operational, clinical, and regulatory fronts over the course of the past quarter and are poised to execute on our near-term milestones. With the clearance from the FDA, as well as the NMPA, to proceed with our Phase 3 program in the United States and China, our team is laser focused on driving LB1148 forward as quickly and efficiently as possible. Additionally, we made progress on the financial front by bolstering our cash position with the completed financing,” commented Tom Hallam, Ph.D., Chief Executive Officer of Palisade Bio. “This will position us to take an important step closer to the registration and commercialization of LB1148, which we believe has the potential to establish the standard of care, globally. The leadership team and board are focused on building on our momentum with our pipeline and look forward to unlocking value for all stakeholders of Palisade Bio.”
Clinical Program Update
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 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 FDA to initiate its Phase 3 clinical trial evaluating LB1148 to accelerate the return of bowel function in adult patients undergoing gastrointestinal 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.
Additionally, in May 2022 the Company’s co-development partner Newsoara Biopharma Co. Ltd, received clearance from the NMPA in China to proceed with their Phase 3 clinical trial to evaluate LB1148 for accelerated return of bowel function in adult patients undergoing gastrointestinal surgery.
The expected timelines are management’s current forecasts and will be updated as enrollment progresses.
Expected Upcoming Milestones
- Q2 2022: U.S. Phase 3 study initiation
- 2H 2022: U.S. Phase 3 study first patient enrolled
Prevention of Post-Surgical Abdominal Adhesions: GI Surgery
Digestive enzymes can escape the intestine during abdominal 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.
The Company previously reported data on 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 trial demonstrating LB1148 achieved its primary endpoint with statistically significant improvement in return of bowel function following cardiovascular (CV) 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