Data from Pooled-Analysis of Enteral Protease Inhibitor LB1148 Demonstrated 72% Reduction in the Risk of Adhesion Formation in Patients Undergoing Bowel Resection Surgery
Company to Host Conference Call on Wednesday, March 16, 2022, at 8:30 a.m. EDT
CARLSBAD, Calif., March 16, 2022 — Palisade Bio, Inc. (Nasdaq: PALI), a clinical stage biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, announced data from a Pooled-Analysis of Studies LBS-IST-POI-101 and LBS-POI-201-CN (PROFILE-CN.) These data are featured today at the Next Big Thing session of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) 2022 Annual Meeting, being held in Denver, March 16-19. Highlights are:
- LB1148 reduced incidence of adhesions by 72% in patients undergoing bowel resection
- LB1148 reduced extent and severity of adhesions by 93% in patients undergoing bowel resection
- The incidence of adhesions in the placebo group was similar to the published incidence (89% and 90% respectively)
- 100% of placebo-treated subjects underwent a laparoscopic procedure, and 8 of 9 had 1 adhesions
- 75% of the 8 LB1148-treated subjects underwent a laparoscopic procedure, and 2 of 6 had 1 adhesions
- 25% of the 8 LB1148-treated subjects underwent a laparotomy, and neither formed adhesions
- No drug-related serious adverse events occurred in the trials
“The pooled results from these studies suggest that LB1148 has the potential to prevent postoperative adhesions,” said Michael Dawson, M.D., Chief Medical Officer of Palisade Bio. “There is significant unmet need to prevent and reduce adhesions, as they are found in more than 90% of cases after intraabdominal surgery and patients tend to suffer life-long complications. These data are promising as we focus on our mission of protecting intestinal integrity and improving treatment options for patients.”
Studies LBS-IST-POI-101 and LBS-POI-201-CN (PROFILE-CN) assessed the efficacy of LB1148 to reduce the formation of adhesions in subjects undergoing abdominal surgery. Study LBS-IST-POI-101 was a Phase 1, single-center, open-label, study enrolling 11 subjects undergoing GI surgery. The PROFILE-CN study was a 120-subject Phase 2, randomized, double-blind, placebo-controlled study conducted in collaboration with co-development partner, Newsoara Biopharma to evaluate LB1148 for return of GI function in subjects undergoing planned bowel resection surgery. In both trials, a subset of subjects went on to have a second surgery (e.g., stoma take down). In these subjects, adhesions were assessed and quantified at the time of surgical closure during the initial surgery and at the time of opening at the subsequent surgical procedure.
“We are excited about this data as they are extremely encouraging given adhesion prevalence in patients who have abdominal surgery and the serious complications that can occur such as small bowel obstruction, infertility, and chronic abdominal pain. Further, the FDA has recognized the important unmet need for adhesions therapeutics and granted Fast Track designation to LB1148 for the reduction of post-surgical intraabdominal and pelvic adhesions,” said Tom Hallam, Ph.D., Chief Executive Officer of Palisade Bio. “We believe LB1148 can help reduce adhesions and reduce adhesions related complications, while potentially driving down costs for the healthcare system. These studies provide critically important data as we continue to research the potential for LB1148 to reduce post-surgical intraabdominal adhesions in our phase 2 study.”
A total of 3/11 subjects in LBS-IST-POI-101 and 14/120 subjects in LBS-POI-201-CN underwent a second surgery. Data were pooled from the two trials and the incidence as well as the extent, and severity of adhesions were compared for subjects treated with LB1148 versus placebo.
Stonegate Capital Partners will host a conference call today, March 16, 2022, 5:30 a.m. Pacific Time/7:30 a.m. Central Time/8:30 a.m. Eastern Time to further discuss the data. You must register before the webcast to be able to access it. Please click the link below to register for the webcast: https://us06web.zoom.us/webinar/register/WN_ThNZHlT4Q9mBMGrMlxabkg
LB1148 is 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. Evidence suggests that the release of digestive proteases contributes to the temporary loss of normal gastrointestinal function and 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 return of normal GI function, and shorten the duration of costly post-surgery hospital stays.
About Palisade Bio
Palisade Bio is a clinical stage biopharmaceutical company advancing therapies that aid patients suffering with acute and chronic gastrointestinal complications stemming from post-operative digestive enzyme damage. Palisade Bio’s innovative lead asset LB1148, advancing towards Phase 3, is a protease inhibitor with the potential to both reduce abdominal adhesions and help restore bowel function following surgery. Positive data from Phase 2 trials of LB1148 demonstrated safety and tolerability as well as a statistically significant improvement in return of bowel function and decrease in length of stay in ICU and hospital compared to placebo. Palisade Bio believes that its investigational therapies have the potential to address the myriad health conditions and complications associated with chronic disruption of the gastrointestinal epithelial barrier. For more information, please go to www.palisadebio.com.
About Newsoara Biopharma
Newsoara is a biotech company based in Shanghai, China with research laboratories in the Suzhou BioBAY focusing on novel drug research and development to address unmet medical needs in patients with various diseases.
Forward Looking Statements
This communication contains “forward-looking” statements, including, without limitation, statements related to expectations regarding Palisade’s plans for future presentations at investor conferences. Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements are based upon Palisade’s current expectations. Forward-looking statements involve risks and uncertainties. Palisade’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the Company’s ability to advance its clinical programs and the uncertain and time-consuming regulatory approval process. Additional risks and uncertainties can be found in Palisade Bio’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021. Palisade expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Palisade’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
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