• Phase 1 human clinical study of PALI-2108 for the treatment of Ulcerative Colitis (UC) on track to commence before year end
• Based on the modeling and simulations, Palisade has established dose levels and trial design for PALI-2108

Carlsbad, CA, Aug. 08, 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, today provided a progress update on the advancement of development for its lead drug candidate, PALI-2108 towards initiation of Phase 1 clinical trials in healthy volunteers and patients with Ulcerative Colitis (UC). PALI-2108 is an orally administered, locally acting colon-specific PDE4 inhibitor prodrug in development for patients affected by UC.

“To establish the Maximum Recommended Starting Dose (MRSD) for human trials, we utilized several complementary scaling approaches. These methods included integrating data from IV and oral (PO) administrations of PALI-2108 across various species. By modeling total PK data, we have gathered data that we believe accurately translates to exposure in humans and ensures a safe and scientifically grounded starting point for our upcoming planned clinical studies. We are pleased with the progress made and look forward to commencing our Phase 1 clinical trial before the end of the year,” commented Dr. Mitch Jones, CMO of Palisade Bio.

The Company has completed an extensive range of studies to determine the starting dose for PALI-2108 in its planned Phase 1 study. The preclinical studies included pharmacodynamic (PD) studies in mice, pharmacokinetic (PK) studies across multiple species (mice, rats, dogs, and monkeys), and a series of in vitro experiments to profile PALI-2108’s drug metabolism and pharmacokinetics (DMPK) characteristics. Additionally, the Company has completed its pivotal Good Laboratory Practice (GLP) safety and toxicology studies which have provided relevant data for this determination.

Key Findings from PK Modeling and Simulations

• Comprehensive simulations were conducted for both single and multiple dose administrations. Scenarios ranged over expected Phase 1 dosing levels and assessed both single and multiple daily doses. The simulations indicated that dosing regimens with minimal accumulation are both safe and within the doses that demonstrated maximal efficacy in animal models.
• A robust human PK model was constructed by scaling preclinical PK parameters to predict human exposure. This model incorporated both the PK of PALI-2108 and its active metabolite, PALI-0008, providing a solid foundation for the Phase 1 trials.

Based on the modeling and simulations, Palisade Bio has determined a starting dose for healthy volunteers which includes a several orders of magnitude safety margin. The dose levels and trial designs have been selected to ensure patient safety while maximizing the potential therapeutic benefits of PALI-2108. The upcoming Phase 1 clinical trial will focus on evaluating the safety, tolerability, and PK of PALI-2108 in healthy volunteers, UC patients, as well as PD in UC patients. Continuous monitoring and assessment will guide future dose escalation and therapeutic strategies.

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 and Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission on March 26, 2024 and May 13, 2024, respectively. 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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