Palisade Bio Announces Granting of Japanese Patent Covering Composition of Matter for Lead Product Candidate, PALI-2108

Core Viewpoint - Palisade Bio, Inc. is advancing PALI-2108, a novel PDE4 inhibitor targeting ulcerative colitis (UC) and fibrostenotic Crohn's disease (FSCD), addressing significant unmet medical needs in these conditions [1][3] Intellectual Property - The Japan Patent Office has granted a key patent for PALI-2108, providing composition-of-matter protection until 2041, with potential extensions based on regulatory review timelines [2] - This patent strengthens Palisade Bio's global intellectual property portfolio, supporting the development of PALI-2108 and its broader platform of locally activated PDE4 inhibitor prodrugs [2][3] Clinical Development - PALI-2108 has completed Phase 1a studies and is currently in a Phase 1b cohort study for both UC and FSCD, with Phase 2 IND submissions planned for the first half of 2026 [1][3][6] - In a recent Phase 1b trial, PALI-2108 achieved a 100% clinical response in the UC cohort, demonstrating favorable tolerability and pharmacokinetics [6] Mechanism and Design - PALI-2108 is designed for local delivery of PDE4 inhibition specifically to the terminal ileum and colon, minimizing systemic exposure and enhancing therapeutic index [4] - The prodrug is activated by gut microbiota, ensuring targeted release at the site of inflammation and fibrosis, which aims to improve anti-inflammatory and anti-fibrotic effects while reducing common side effects associated with systemic PDE4 inhibitors [4][6] Future Plans - The company is preparing to initiate a Phase 2 clinical study in UC to evaluate clinical remission and pharmacodynamic biomarkers over 12 weeks, with an extension phase for maintenance of remission [7] - Additionally, studies in FSCD are planned to further characterize the safety and therapeutic benefits of PALI-2108 across inflammatory bowel disease indications [7]