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

First dual-acting anti-inflammatory and anti-fibrotic candidate in development for FSCD, a condition with no approved therapies

Patient dosing expected to commence in H2 2025; Topline data anticipated in Q1 2026

Continued progress toward Phase 2 IND submissions in Q1 2026

Excerpt from the Press Release:

Carlsbad, CA, Sept. 05, 2025 (GLOBE NEWSWIRE) — Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade,” “Palisade Bio,” or the “Company”), a clinical-stage biopharmaceutical company developing precision therapies for autoimmune, inflammatory, and fibrotic diseases, today announced that it received 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 clinical study for the treatment of fibrostenotic Crohn’s disease (FSCD).

Up to half of Crohn’s disease patients develop FSCD over the course of their illness, and there are currently no approved anti-fibrotic therapies. Current standards of care—including corticosteroids, endoscopic balloon dilation, and surgery—primarily address symptoms but fail to alter the fibrotic disease process, with many patients requiring repeated interventions or resections.

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 (PK) in plasma and intestinal tissues (ileum, ascending and descending colon);
• Pharmacodynamics (PD) including paired ileal biopsies analyzed by RNA sequencing; and
• Exploratory endpoints such as histology, intestinal ultrasound (IUS), 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.

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