Palisade Bio receives Health Canada clearance for Phase 1b PALI-2108 trial

Palisade Bio (PALI) received a No Objection Letter from Health Canada for its Clinical Trial Application to evaluate PALI-2108, a first-in-class, ileocolonic-targeted PDE4 B/D inhibitor, in a Phase 1b clinical study for the treatment of fibrostenotic Crohn’s disease. The open-label Phase 1b study will enroll approximately 6-12 patients to evaluate: Safety and tolerability through adverse event monitoring, labs, and EKGs; Pharmacokinetics in plasma and intestinal tissues; Pharmacodynamics including paired ileal biopsies analyzed by RNA sequencing; and Exploratory endpoints such as histology, intestinal ultrasound, and patient-reported outcomes. Dosing is expected to begin in the second half of 2025, with topline safety, PK, and PD readouts anticipated in the first quarter of 2026. Data from this Phase 1b FSCD study, together with results from Palisade’s completed Phase 1a/1b trials in ulcerative colitis, will support the Company’s planned Phase 2 IND submission to the U.S. Food and Drug Administration in the first half of 2026.