Statistically significant 1.1-day acceleration in return of bowel function
Favorable overall safety profile in 120 patients
CARLSBAD, Calif. and SHANGHAI, China, July 29, 2021 — Palisade Bio, Inc. (Nasdaq: PALI) and co-development partner Newsoara today announced positive topline Phase 2 clinical trial data that LB1148 had a statistically significant (p=0.0008) effect in accelerating the return of bowel function in patients undergoing elective bowel resection surgery.
“These results demonstrate a strong efficacy profile in acceleration of the time to recover bowel function combined with a favorable safety and tolerability profile,” said Tom Hallam, Ph.D., CEO of Palisade Bio. “We believe LB1148 can simplify the surgical journey for these patients, helping them get better faster, while potentially reducing costs to the healthcare system. Further, LB1148 has now shown statistically significant acceleration of return of bowel function in a Phase 2 study for cardiovascular surgery and in a Phase 2 study for GI surgery. These data lay the important groundwork for proceeding to pivotal studies for these indications. We are grateful to all patients that participated in this trial as well as our international collaborators, and we look forward to continued efforts to bring this therapy to patients in need.”
“We are delighted that the results from our Phase 2 study brings us another step closer to potentially launching the first protease inhibitor indicated to accelerate the return of GI function,” said Dr Benny Li, Newsoara’s Chief Executive Officer. “Delayed return of bowel function impacts millions of patients across the globe every year, yet the treatment landscape for this global population has been relatively unchanged for decades. LB1148 has the potential to be transformative for patients undergoing major surgery to address this significant unmet need.”
The Phase 2, multicenter, randomized, double-blind, parallel, placebo-controlled clinical trial was completed as part of a co-development agreement between Palisade Bio and Newsoara. The study involved 120 patients undergoing elective bowel resection surgery and included laparotomy and laparoscopic surgical approaches. In addition, the study included patients undergoing either anastomosis or stoma creation. The primary outcome was recovery of bowel function measured as the time from the end of surgery to oral food tolerance and passage of stool.
Results from the study include:
- A 1.1-day improvement in GI recovery in patients receiving LB1148 vs placebo. The median time to return of bowel function was 2.77 days in patients treated with LB1148 and 3.83 days in those receiving placebo (hazard ratio = 1.886; p = 0.0008).
- The difference between groups increased at the 3rd quartile (75th percentile), with LB1148 (3.4 days) demonstrating a 1.5-day faster recovery of bowel function compared to placebo (4.9 days).
- LB1148 was well tolerated with only 10.9% and 4.8% of patients in the LB1148 group and placebo group, respectively, experiencing a drug-related adverse event.
- The most common drug-related adverse events were GI disorders (LB1148 4.7% vs. placebo 3.2%). No drug-related serious adverse events occurred in the trial.
Dr. Michael Dawson, M.D., Palisade Bio’s Chief Medical Officer added, “It’s very encouraging that the accelerated return of bowel function due to LB1148 in this study is larger in magnitude than any of the five controlled studies that were submitted to the U.S. FDA for approval of Entereg, the only approved product in this indication. Full results from this study are expected to be reported at an upcoming surgical-focused medical conference later this year.”
Based on the beneficial clinical outcomes and good safety profile observed to date in phase 2 trials in both CV surgery and GI surgery, Palisade Bio and Newsoara plan to advance LB1148 to pivotal Phase 3 clinical trials for accelerating the return of bowel function for major surgical indications.
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, Inc.
Palisade Bio is a late-stage biopharma company advancing therapies that help patients with acute and chronic gastrointestinal complications stemming from post-operative digestive enzyme damage. Palisade Bio’s innovative lead asset, LB1148, is a Phase 3-ready protease inhibitor with the potential to both reduce abdominal adhesions and help restore bowel function following surgery. Positive data from a Phase 2 trial of LB1148 demonstrated safety and tolerability as well as a statistically significant improvement in return to 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.
Forward Looking Statements
This communication contains “forward-looking” statements, including, without limitation, statements related to expectations regarding Palisade’s plans for future clinical development of LB1148, plans for potential commercial launch of LB1148 and the potential for LB1148 to be transformative for patients. 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, related to 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 (formerly known as Seneca Biopharma, Inc.) Quarterly Report on Form 10-Q for the quarter ended March 31, 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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