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Highlights

  • Palisade Bio received a No Objection Letter from Health Canada for its Clinical Trial Application to evaluate PALI-2108 in fibrostenotic Crohn’s disease.

  • The open-label Phase 1b study will enroll 6–12 patients, with dosing expected to begin in the second half of 2025.

  • Topline safety, pharmacokinetics, and pharmacodynamics results are anticipated in the first quarter of 2026.

Palisade Bio, Inc. (NASDAQ:PALI), a clinical-stage biopharmaceutical company developing therapies for autoimmune, inflammatory, and fibrotic diseases, announced that it has received a No Objection Letter (NOL) from Health Canada for its Clinical Trial Application. The approval allows the company to advance PALI-2108, a first-in-class ileocolonic-targeted PDE4 B/D inhibitor, into a Phase 1b study for fibrostenotic Crohn’s disease (FSCD).

FSCD affects up to half of Crohn’s disease patients during the course of illness. Currently, no approved anti-fibrotic therapies exist, and treatments such as corticosteroids, balloon dilation, and surgery primarily address symptoms without altering the fibrotic disease process.

Study Design and Objectives

The open-label Phase 1b trial will enroll approximately 6–12 patients. Key objectives include:

  • Safety and tolerability: Assessed through adverse event monitoring, laboratory tests, and electrocardiograms.

  • Pharmacokinetics (PK): Measurement in plasma and intestinal tissues, including ileum and colon segments.

  • Pharmacodynamics (PD): Paired ileal biopsies analyzed by RNA sequencing.

  • Exploratory endpoints: Histology, intestinal ultrasound (IUS), and patient-reported outcomes.

Dosing is expected to begin in the second half of 2025. Palisade anticipates topline readouts on safety, PK, and PD in the first quarter of 2026.

PALI-2108: A Targeted Approach

PALI-2108 is an orally administered prodrug engineered for gut-restricted delivery of PDE4 B/D inhibition to the terminal ileum and colon. The drug candidate is activated by bacterial enzymes in the lower intestine, achieving high local tissue concentrations while limiting systemic exposure.

This targeted design is intended to optimize anti-inflammatory and anti-fibrotic activity while reducing class-related side effects—such as nausea and headache—that have historically constrained systemic PDE4 inhibitors.

Path Toward Phase 2 Development

The Phase 1b trial in FSCD builds on Palisade’s earlier Phase 1a/1b clinical studies in ulcerative colitis. Together, the data will support a planned Phase 2 Investigational New Drug (IND) submission to the U.S. Food and Drug Administration in the first half of 2026.

About Palisade Bio

Palisade Bio is a clinical-stage biopharmaceutical company focused on advancing precision therapies for autoimmune, inflammatory, and fibrotic diseases. Its pipeline aims to address conditions with high unmet medical need, where current standards of care are limited to symptomatic management rather than disease modification.