Company approaching Phase 2 topline data readout for prevention of post-surgical abdominal adhesions
Continued momentum with execution of ongoing dose optimization study with 25% enrollment complete
Carlsbad, CA, May 24, 2023 (GLOBE NEWSWIRE) — Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, today provided a clinical program update for its lead product candidate, LB1148, a broad-spectrum serine protease inhibitor which acts to neutralize digestive enzymes, potentially reducing intestinal damage.
“We remain focused on our U.S. Phase 2 adhesions study with our lead drug, LB1148, and look forward to our data readout in the coming weeks. We believe the topline data from our Phase 2 study will provide valuable insight related to future trial design,” commented J.D. Finley, interim Chief Executive Officer. “Additionally, we have made rapid progress in our dose optimization study. We have already dosed eight patients and remain on track to have that topline data in the third quarter of this year.”
“We continue to believe there is great potential for LB1148 to fundamentally transform the way physicians mitigate the risks of acute and chronic GI complications from surgery. We are grateful for the continued support of all our stakeholders and look forward to the continued advancement of LB1148,” concluded Mr. Finley.
U.S. Phase 2 Adhesions Study
LB1148 is currently being evaluated in a Phase 2 study for its effectiveness in reducing intra-abdominal adhesions, accelerating return of gastrointestinal function, and the prevention of post-operative ileus in patients undergoing elective bowel resection (PROFILE).
Many of the patients enrolled in PROFILE have cancer, and most continue adjuvant therapy after completing the initial surgery. Once the patient has been treated and cleared for surgery, the second surgery is scheduled. Per the clinical trial protocol, the patient has up to eight months from the initial surgery to complete the second surgery, and the last patient out is expected on or before June 24, 2023. The Company expects to report topline data within four weeks following the last surgery.
Dose Optimization Study
The Company recently commenced patient enrollment and dosing in its ongoing dose optimization study. The dose optimization study is being conducted to determine if a different dosing protocol might enhance the risk profile while simultaneously providing efficacy for the development program moving forward. The study is expected to enroll approximately 32 healthy subjects. To date eight subjects, or 25%, have been enrolled and dosed. The Company expects to complete enrollment and report topline data in Q3 2023.
About Palisade Bio
Palisade Bio is a biopharmaceutical company focused on developing therapeutics that protect the integrity of the intestinal barrier. The Company utilizes over three decades of research and established science that links the role of intestinal barrier biology with human disease to advance novel therapeutics that target and improve the integrity of the intestinal barrier.
The Company’s lead program, LB1148, is a broad-spectrum serine protease inhibitor that acts to neutralize digestive enzymes, potentially reducing intestinal damage. In prior clinical studies, LB1148 has demonstrated positive results in reducing the incidence and severity of post-surgical abdominal adhesions and potentially reducing the time to return of postoperative bowel function. LB1148’s current U.S. Phase 2 study is evaluating its effectiveness in reducing intra-abdominal adhesions, accelerating return of gastrointestinal function, and the prevention of post-operative ileus in subjects undergoing elective bowel resection (PROFILE).
The Company believes that addressing the disruption of the intestinal barrier can fundamentally change the way diseases are treated and establish new standards of patient care. For more information, please go to www.palisadebio.com.
Forward Looking Statements
This communication contains “forward-looking” statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the extent of our cash runway; estimates about the size and growth potential of the markets for our product candidates, and our ability to serve those markets, including any potential revenue generated; future regulatory, judicial, and legislative changes or developments in the United States (U.S.) and foreign countries and the impact of these changes; our ability to build a commercial infrastructure in the U.S. and other markets; our ability to compete effectively in a competitive industry; our ability to identify and qualify additional manufacturers to provide API and manufacture drug product; our ability to enter into commercial supply agreements; the success of competing technologies that are or may become available; our ability to attract and retain key scientific or management personnel; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; our ability to obtain funding for our operations; our ability to attract collaborators and strategic partnerships; and the impact of the COVID-19 pandemic on our business, and operations, and supply. 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 the Company’s current expectations. Forward-looking statements involve risks and uncertainties. The Company’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, the uncertain and time-consuming regulatory approval process; and the Company’s ability to achieve additional financing to fund future operations. Additional risks and uncertainties can be found in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 22, 2023. These forward-looking statements speak only as of the date hereof and the Company 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 the Company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
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Source: Palisade Bio