• ta presented at Digestive Disease Week (DDW) 2024
• Preclinical data demonstrate PALI-2108 to be safe, effective, and well tolerated
• PALI-2108 is orally delivered and colon-specific allowing for local activity with low systemic exposure
• PALI-2108 exhibited a dose-dependent efficacy response in two DSS colitis mouse models, achieving efficacy comparable to doses of apremilast considered intolerable for human use in Ulcerative Colitis (UC) patients
• Company on track to commence Phase 1 human clinical study of lead product candidate, PALI-2108, for the treatment of UC before year end

Carlsbad, CA, May 21, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced the presentation of positive preclinical data from PALI-2108, an orally administered, locally acting colon-specific Phosphodiesterase-4 (PDE4) inhibitor prodrug in development for patients affected by UC, at DDW 2024 being held in Washington, D.C., May 18-21, 2024.

The poster titled, “Local Bioactivation and efficacy of PALI-2108: A Promising PDE4 Inhibitor Prodrug for Ulcerative Colitis Treatment,” is being presented by Dr. Mitch Jones as part of the Animal Models of IBD: Pre-Clinical Treatment of Intestinal Inflammation session being held today, May 21, 2024. The poster is available on the Scientific Publications page of the Company’s website.

“The findings from this preclinical study add to our growing body of encouraging data for PALI-2108 and further bolster our confidence in its potential in the treatment of UC,” commented Dr. Mitch Jones, CMO of Palisade Bio. “Based on the data demonstrated to date, we believe PALI-2108 has the potential to be the first approved PDE4 inhibitor for UC and importantly, provide a much-needed solution for patients.”

The preclinical data highlighted in the poster reveal significant advancements in assessing on-target PDE4 binding within colon tissue homogenates when dosed with apremilast, PALI-2108, or Vehicle, utilizing a classic cellular thermal shift assay (CETSA) to detect changes in thermal stability.

To comprehensively evaluate PALI-2108's efficacy across various doses, researchers employed an acute colitis model in mice induced by 4% DSS in drinking water from Day 1 to Day 8. Mice received twice-daily (BID) treatments of PALI-2108 at 20, 40, and 80 mg/kg/dose BID, while cyclosporin A and apremilast were administered at 40 and 12.5 mg/kg/dose BID, respectively. The assessment of DSS-induced colitis included monitoring Body Weight score, Stool Consistency score, and Fecal Blood score from Day 1 to Day 8, with evaluations conducted 1 to 2 hours post-dosing. Overall disease state was measured using a Disease Activity Index (DAI) score, calculated by pooling the three in-life scores, assessed daily from Days 1 to 8.

Furthermore, a single oral dose of the prodrug PALI-2108 at 43 mg/kg and active PALI-0008 at 0.1, 0.3, 1, and 3 mg/kg was administered to dogs, with a focus on monitoring key clinical adverse events, including emesis. Remarkably, the PALI-2108 prodrug prevented emesis observed with lower doses of the PDE4 active moiety in the model, demonstrating an enhanced therapeutic window.

Key Findings

• PALI-2108 demonstrates similar target engagement to the PDE4 inhibitor, apremilast, which is approved for use in psoriasis and psoriatic arthritis.
• In a DSS colitis mouse model, PALI-2108 significantly prevented colon length reduction in dose dependent manner, and showed dose dependent improvements in body weight score, stool consistency score, fecal blood score, overall disease activity index (DAI) score, and AUC of DAI over the course of the study.
• Importantly, PALI-2108 exhibited a dose-dependent efficacy response in two DSS colitis mouse models, achieving efficacy comparable to doses of apremilast considered intolerable for human use in UC patients.
• No systemic toxicity in dogs and large therapeutic window due to local activation.

About Palisade Bio

Palisade Bio is a 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 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; our ability to successfully develop our licensed technologies; 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 the COVID-19 pandemic or 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. 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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