Health Canada has issued a no-objection letter for Palisade Bio’s clinical trial application in preparation for an open-label Phase Ib study of the ileocolonic-targeted PDE4 B/D inhibitor, PALI-2108, aimed at treating fibrostenotic Crohn’s disease (FSCD).
This condition affects up to 50% of individuals with Crohn’s disease.
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The upcoming trial is set to involve 6-12 subjects and will focus on assessing the therapy’s tolerability and safety through various methods, including monitoring the adverse events, laboratory tests, and electrocardiograms (EKGs).
In addition, it will examine the pharmacokinetics in plasma and intestinal tissues, as well as its pharmacodynamics through RNA sequencing of paired ileal biopsies.
Exploratory endpoints will also be evaluated, including intestinal ultrasound, histology, and outcomes reported by patients.
Subject dosing is scheduled to commence in the latter half of 2025, with initial pharmacokinetic, safety, and pharmacodynamic results expected in the first quarter of 2026.
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By GlobalDataThese findings, combined with data from previous Phase Ia/Ib studies in ulcerative colitis (UC), will inform Palisade Bio’s planned Phase II investigational new drug application (IND) submission in the first half of 2026 to the US Food and Drug Administration.
Palisade Bio chief medical officer Dr Mitchell Jones said: “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.
“Our team is now focused on initiating patient dosing in the coming months and advancing toward Phase II.”
The orally administered prodrug, PALI-2108, is designed to deliver PDE4 B/D inhibition directly to the terminal ileum and colon.
According to the company, it is activated by bacterial enzymes present in the lower intestine, allowing for localised tissue concentrations and minimal systemic exposure.
In August 2025, Palisade reported encouraging results from a Phase Ib open-label cohort of PALI-2108 in patients with moderate-to-severe UC.
