CARLSBAD, Calif. and SHANGHAI, China, May 07, 2021 — 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.
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 Phase 2 trials 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 anticipated timing for clinical trial results, and other statements related to Palisade’s development programs. 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 preclinical 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.) Registration Statement on Form S-4 initially filed with the SEC on December 23, 2020, as amended. 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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