• Company on track to commence Phase 1 human clinical study of PALI-2108 for the treatment of Ulcerative Colitis (UC) before year end

Carlsbad, CA, May 01, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade”, “Palisade Bio” or the “Company”), a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, announced today the successful completion of its analysis to determine the effects of bioactivated PALI-2108 on TNF-α production in a whole blood (WB) assay. PALI-2108 is Palisade’s orally administered, locally acting, colon-specific phosphodiesterase-4 (PDE4) inhibitor prodrug in development for patients affected by UC.

"These important data bolster our confidence in the robust anti-inflammatory potential of PALI-2108 in the management of UC," said Dr. Mitch Jones, CMO of Palisade Bio. "The superior efficacy of PALI-2108, as demonstrated by its lower half-maximal inhibitory concentration (or IC50) compared to the approved PDE4 inhibitor apremilast, underscores its potential as a next-generation therapeutic option for patients with inflammatory bowel disease."

This study included WB samples from 14 clinically healthy adults (five women and nine men). Twelve samples meeting the inclusion criteria were included for TNF-α measurement and calculation of IC50 values. Donor whole blood was treated with different concentrations of PALI-2108 and two control compounds known to inhibit the PDE4 pro-inflammatory pathway. Blood was then challenged with the pro-inflammatory molecule lipopolysaccharide (LPS). Anti-inflammatory potency was determined by calculating the IC50 values for TNF-α inhibition.

Findings from the study demonstrated that PALI-2108 exhibited efficacy in inhibiting TNF-α production induced by LPS in this ex-vivo peripheral whole blood assay. Pre-treatment of human whole blood samples with bioactivated PALI-2108 resulted in a significant reduction in LPS-induced TNF-α production compared to non-pretreated samples. Specifically, the Company’s proprietary PDE4 inhibitor, shown to be released by the local bioconversion of PALI-2108 prodrug in the colon, demonstrated a mean IC50 for TNF-α inhibition of 0.022 µM, compared to 0.41 µM for apremilast, showcasing its potent anti-inflammatory activity. The study was conducted in collaboration with Paraza Pharma, Inc based in Montreal, QC.

JD Finley, CEO of Palisade Bio, added “Our team’s exceptional operational execution is driving the clinical development of PALI-2108 towards our first-in-human study, which is on track to start later this year. We are committed to advancing our pioneering research initiatives aimed at improving the lives of patients suffering from UC and other inflammatory conditions.”

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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