Palisade Bio Launches Clinical Steering Committee to Provide Clinical Oversight and Guide Preparation for Late-Stage Clinical Trials of LB1148 in Accelerating Postoperative Return of Bowel Function and Reduction of Post-Surgical Adhesions
Palisade Bio, Inc. (Nasdaq: PALI), a late-stage biopharma company, announced the formation of a Clinical Steering Committee (CSC) led by Dr. David Berry to guide late-stage development of its investigational drug LB1148. The CSC is expected to enhance pivotal Phase 3 programs in 2022, focusing on preventing post-surgical gastrointestinal complications. Currently in a Phase 2 trial, LB1148 aims to accelerate bowel function return after GI surgery. Preliminary data from a co-development study with Newsoara is expected soon, marking a critical juncture for the company.
- Formation of a Clinical Steering Committee with renowned experts to guide LB1148's clinical development.
- Active Phase 2 trial for LB1148, targeting accelerated bowel function return post-surgery.
- Positive preliminary outcomes expected from a completed sister Phase 2 study.
- None.
Former Leading BioSciences Chairman and Retired Board-Certified Surgeon, Dr. David Berry to Serve as Chair
CARLSBAD, Calif., June 15, 2021 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) a late-stage biopharma company advancing therapies for acute and chronic gastrointestinal (GI) complications, today announced the launch of its Clinical Steering Committee (CSC) designed to provide strategic guidance over late-stage clinical program development for its lead investigational drug, LB1148. The CSC will be chaired by retired board-certified-surgeon, Dr. David Berry, who previously served as Chairman of the Board of the predecessor company, Leading BioSciences.
Additional CSC members include:
- Mark A. Talamini, MD, Vice President of Surgery & Program Development, Northwell Health
- Jerrold H. Levy, MD, Professor of Anesthesiology and Critical Care Professor of Surgery (Cardiothoracic) Duke University Hospital
- Steven D. Wexner, MD, PhD, Director of the Digestive Disease Institute and Chairman of Colorectal Surgery, Cleveland Clinic Florida
- Ronald Hurst, MD, Division of Surgical Oncology at The Angeles Clinic and Research Institute
- Paul A. Checchia, MD, Professor of Pediatrics at Texas Children's Hospital
“With a number of important clinical milestones expected in 2021, our Clinical Steering Committee will be integral to successful design and execution of our planned pivotal Phase 3 programs in 2022,” said Tom Hallam, Ph.D., CEO of Palisade Bio. “We're driven by the potential for LB1148 to be a difference-maker in prevention of a number of post-surgical GI complications and look forward to working with Dr. Berry and the rest of the CSC to advance these programs expeditiously.”
Palisade Bio is currently in a Phase 2 clinical trial evaluating lead drug candidate LB1148 for accelerating return of bowel function associated with gastrointestinal (GI) surgery. The PROFILE study is a randomized, double-blind, multicenter, Phase 2 trial expected to enroll 120-200 patients undergoing elective bowel resection at 11 sites across the U.S. Patients received a single oral dose of LB1148 prior to surgery. The primary endpoint is time to return of bowel function. The presence of adhesions will be assessed in patients scheduled for a second surgery withing seven months of the initial GI surgery.
A sister Phase 2 study that is virtually identical in design to PROFILE, was recently completed with co-development partner Newsoara (Shanghai, China). It included more than 120 patients, has the same primary and secondary endpoints as PROFILE, and preliminary top-line data are expected to be announced by the end of Q2 2021.
Dr. Berry remarked, “With the imminent data from Phase 2 clinical trials of LB1148 we're entering a critical juncture for design of late-stage pivotal trials that we hope will generate the data supportive of FDA approval. I look forward to continuing to work with the exceptional team at Palisade Bio to advance the global LB1148 clinical program to potentially bring this much needed oral therapy to market as a safe and effective therapeutic option to restore bowel function after surgeries and reduce post-surgical abdominal adhesions.”
Before joining the CSC at Palisade Bio, Dr. Berry brought deep medical, business and board leadership to Leading BioSciences. He is a retired urologic surgeon with 36 years of experience in endoscopic and open surgical procedures. He has served as a clinical associate professor at the University of Nevada Medical School and diplomate of the American Board of Urology. Committed to cutting-edge medical research, his roles have ranged from advisory boards to principal investigator for clinical trials. In addition to his clinical and scientific achievements, Dr. Berry is also an accomplished entrepreneur and business executive, having founded multiple profitable healthcare companies spanning surgical and oncology radiation centers, medical management, and health insurance. Dr. Berry earned his bachelor’s degree in biology from The College of Wooster (Wooster, Ohio) and his medical degree from Tulane University. He completed his general surgery residency training at the University of California Davis, and his urologic residency training at Tulane Affiliated Hospitals in New Orleans, Louisiana. During his training at Tulane, Dr. Berry also completed a cancer research fellowship and served as fellow for the National Prostate Cancer Project.
About LB1148
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 the anticipated timing and results of clinical trials, 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.) 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.
Palisade Bio Investor Relations Contact:
CORE IR
ir@palisadebio.com
Palisade Bio Media Relations Contact:
CORE IR
Jules Abraham
julesa@coreir.com
917-885-73478
Corporate Contact:
Justin Stege, Ph.D.
justin.stege@palisadebio.com
Source: Palisade Bio
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