Data to be presented at the 8



th



Annual Antifibrotic Drug Development (AFDD) Summit

PALI-2108 may offer a solution for fibrostenotic Crohn's disease by enhancing efficacy, safety, and therapeutic potential compared to traditional treatments

Carlsbad, CA, Nov. 21, 2024 (GLOBE NEWSWIRE) --

Palisade Bio, a clinical-stage biopharmaceutical company focused on developing novel therapeutics for autoimmune, inflammatory, and fibrotic diseases, today announced preclinical results for PALI-2108, a novel local PDE4 inhibitor prodrug. In recent studies using the Dextran Sulfate Sodium (DSS) colitis mouse model, PALI-2108 demonstrated a dose-dependent effect on key fibrotic pathways, underscoring its potential as an effective treatment for fibrostenotic Crohn's disease.

The data will be presented as part of an invited talk titled, "

Detailing Characteristics of Fibrostenotic Crohn's Disease Biology & the Potential of a Local PDE4 Inhibitor Prodrug to Minimize Off-Target Effects & Maximize Efficacy,

" delivered by Mitch Jones, MD, PhD, Chief Medical Officer of Palisade Bio, at the 8th Annual Antifibrotic Drug Development Summit, being held November 19-21, 2024, in Boston, MA.

"There remains an unmet need in Crohn's disease, with a number of patients experiencing substantial fibrosis resulting in stenosis at least once in their lifetime, often necessitating surgical intervention," said Dr. Jones. "Our findings in the DSS mouse model seem to demonstrate that PALI-2108 holds considerable promise as a targeted, dual-action (pleiotropic) anti-inflammatory and anti-fibrotic agent for treating fibrostenotic Crohn's disease, a condition we believe is inadequately addressed by current therapies. The data seems to indicate that PALI-2108 engages and modulates key fibrotic pathways directly in the intestinal and colonic mucosa, addressing the root cause of fibrosis while minimizing systemic side effects commonly associated with systemic PDE4 inhibitors. This offers what we believe could be a safer and more effective treatment option for patients."

The study evaluated PALI-2108 in an animal model of inflammatory bowel disease (IBD), often complicated by intestinal fibrosis. PALI-2108, a prodrug activated locally in the ileum and colon, was found to modulate key fibrotic pathways associated with both Crohn's disease and UC. A comprehensive analysis of gene expression revealed that PALI-2108 affected 187 genes involved in the four main fibrotic pathways of IBD, demonstrating an upregulation and downregulation of key markers. This suggests that PALI-2108 has the potential to reverse or prevent fibrotic progression in the intestines.

The study further revealed that PALI-2108 reduced key intracellular markers of inflammation and fibrosis in the colon, including PDE4B expression, while increasing cAMP levels—a crucial factor in maintaining tissue homeostasis. Notably, the dose-response relationship showed that higher doses of PALI-2108 further enhanced the fibrotic signature, reinforcing its potential as an effective, localized treatment for patients suffering from fibrostenotic Crohn's disease. The data also seemed to demonstrate that PALI-2108 offers enhanced safety and therapeutic potential compared to traditional treatments. Unlike systemic PDE4 inhibitors, PALI-2108 is designed to be activated locally, reducing the risk of common side effects such as nausea, which are frequently seen with oral PDE4 inhibitors like oral and inhaled roflumilast (AstraZeneca) for fibrotic COPD and oral apremilast (Amgen) and for inflammatory diseases like psoriasis and psoriatic arthritis.

The Company is evaluating PALI-2108 in a Phase 1 single-center, double-blind, placebo-controlled study focused on safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers, alongside an open-label study involving UC patients. Topline data from the Phase 1 study is expected in the first half of 2025. For more information, visit clinicaltrials.gov and reference identifier


NCT06663605


.

About PALI-2108

PALI-2108 is an orally administered, locally acting colon-specific PDE4 inhibitor prodrug in development for patients affected by UC. The Company recently commenced a Phase 1 single-center, double-blind, placebo-controlled study of PALI-2108 focused on safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers, alongside an open-label study involving a patient cohort with UC. It is anticipated that the comprehensive data gathered will support Palisade Bio's precision medicine strategy, aimed at identifying patient responders for future clinical studies.

About Palisade Bio

Palisade Bio is a clinical-stage biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases. The Company believes that by using a targeted approach with its novel therapeutics it will transform the treatment landscape. For more information, please go to





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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; our ability to successfully develop our licensed technologies; the timing and outcome of our current and anticipated applications and studies related to our product candidates; 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 maintain the Nasdaq listing of our securities; 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 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 any global event 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 nonclinical and clinical programs, the uncertain and time-consuming regulatory approval process; and the Company's ability to secure additional financing to fund future operations and development of its product candidates. Additional risks and uncertainties can be found in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the Securities and Exchange Commission ("SEC") on March 26, 2024, and any Quarterly Reports on Form 10-Q or other SEC filings that were filed thereafter. 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.

Investor Relations Contact

JTC Team, LLC
Jenene Thomas
908-824-0775


PALI@jtcir.com