Palisade Bio Begins Phase 1b Trial for Crohn’s Disease in Canada, UK, Australia

Palisade Bio has received a No Objection Letter from Health Canada to initiate a Phase 1b clinical trial for PALI-2108, a first-in-class ileocolonic-targeted PDE4 B/D inhibitor aimed at treating fibrostenotic Crohn’s disease (FSCD), a condition currently lacking approved anti-fibrotic therapies. The open-label study will enroll approximately 6 to 12 patients to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and exploratory endpoints such as histology and patient-reported outcomes. Patient dosing is expected to begin in the second half of 2025, with topline data anticipated in the first quarter of 2026. Palisade Bio emphasizes that PALI-2108 is the first dual-acting anti-inflammatory and anti-fibrotic candidate in development for FSCD, addressing an unmet need as current treatments primarily manage symptoms without altering the fibrotic process. Data from this trial, along with completed Phase 1a/1b studies in ulcerative colitis, will support a planned Phase 2 IND submission to the FDA in the first half of 2026. The company is positioned as a clinical-stage biopharmaceutical focused on precision therapies for autoimmune and fibrotic diseases, although it currently operates without revenue and faces financial challenges.