Palisade Bio Receives Health Canada Clearance for Phase 1b Trial of PALI-2108 in Fibrostenotic Crohn's Disease (FSCD)

Core Insights - Palisade Bio is developing PALI-2108, a first-in-class dual-acting anti-inflammatory and anti-fibrotic therapy for fibrostenotic Crohn's disease (FSCD), which currently has no approved treatments [1][3] - The company received a No Objection Letter from Health Canada for its Clinical Trial Application, allowing it to proceed with a Phase 1b clinical study [1][3] - Patient dosing is expected to begin in the second half of 2025, with topline data anticipated in the first quarter of 2026 [1][2] Company Overview - Palisade Bio is a clinical-stage biopharmaceutical company focused on precision therapies for autoimmune, inflammatory, and fibrotic diseases [5] - The company aims to transform the treatment landscape by developing targeted therapeutics [5] Product Details - PALI-2108 is an orally administered prodrug designed for gut-restricted delivery, targeting the terminal ileum and colon [4] - The drug is activated by bacterial enzymes in the lower intestine, achieving high local tissue concentrations while minimizing systemic exposure [4] - This design aims to enhance anti-inflammatory and anti-fibrotic effects while reducing common side effects associated with systemic PDE4 inhibitors [4] Clinical Study Information - The Phase 1b study will enroll approximately 6-12 patients to evaluate safety, pharmacokinetics (PK), and pharmacodynamics (PD) [2][7] - The study will include monitoring of adverse events, laboratory tests, EKGs, and paired ileal biopsies analyzed by RNA sequencing [7] - Data from this study, along with results from previous trials in ulcerative colitis, will support the planned Phase 2 IND submission to the FDA in the first half of 2026 [3]