Palisade Bio (NASDAQ: PALI) has announced receiving a No Objection Letter (NOL) 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 study for the treatment of fibrostenotic Crohn’s disease (FSCD).
According to Palisde, 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.
In a statement, Dr. Mitchell Jones, CMO of Palisade, commented, “This Health Canada clearance marks an important milestone for PALI-2108 as the first dual anti-inflammatory and anti-fibrotic therapy in development for FSCD. Our preclinical and clinical data demonstrate that PALI-2108 is ileum and colon targeted and locally bioactivated, safe, and well tolerated, while showing robust antifibrotic activity alongside potent anti-inflammatory effects. We believe this differentiated profile positions PALI-2108 addresses the urgent and growing need for therapies that go beyond symptom management to alter the course of FSCD. Our team is now focused on initiating patient dosing in the coming months and advancing toward Phase 2.”
