Palisade Bio Granted Canadian Patent Covering Composition of Lead Product Candidate PALI-2108

PALI-2108 is the first and only PDE4 inhibitor designed to target terminal ileum and colon for fibrostenotic Crohn’s disease (FSCD) and ulcerative colitis (UC) to address significant unmet medical needs

Carlsbad, CA, Oct. 13, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade,” “Palisade Bio,” or the “Company”), a clinical-stage biopharmaceutical company developing precision therapies for autoimmune, inflammatory, and fibrotic diseases, today announced that the Canadian Intellectual Property Office (CIPO) has granted patent number 3,174,137 titled, “Gut Microbiota Bioactivated PDE4 Inhibitor Precursors.” The patent covers the composition of PALI-2108, the Company’s orally administered, first-in-class, ileocolonic-targeted PDE4 B/D inhibitor in development for the treatment of FSCD and UC.

J.D. Finley, Chief Executive Officer of Palisade commented, “We remain committed to strengthening the intellectual property portfolio around PALI-2108 and are focused on advancing the development of this program. The granting of this patent marks an important addition to our global IP portfolio estate . Our team continues to execute on our clinical milestones, and we look forward to pursuing the full therapeutic promise of PALI-2108 to treat patients with FSCD and UC.”

The patent provides composition-of-matter protection for PALI-2108 through May 28, 2041. PALI-2108’s unique design incorporates a galactose-derived sugar moiety that allows for minimal absorption until converted by the colonic bacterium enzyme β-glucuronidase. This mechanism is intended to ensure localized bioactivation, leading to colon-specific distribution with reduced systemic exposure, as demonstrated in a tissue distribution study.

Palisade Bio continues to advance the development of PALI-2108 in its Phase 1b FSCD study with patient dosing expected to commence in H2 2025 and topline data expected in Q1 2026. Data from the FSCD Phase 1b, together with results from Palisade’s completed Phase 1a/1b trials in UC, will support the Company’s planned Phase 2 IND submission to the U.S. Food and Drug Administration (FDA) in the first half of 2026.

About PALI-2108

PALI-2108 is an orally administered prodrug engineered for gut-restricted delivery of PDE4 B/D inhibition to the terminal ileum and colon. Activated by bacterial enzymes in the lower intestine, PALI-2108 achieves high local tissue concentrations while minimizing systemic exposure. This design aims to maximize anti-inflammatory and anti-fibrotic effects while reducing class-related tolerability issues such as nausea and headache that have historically limited systemic PDE4 inhibitors.