Palisade Bio, Inc. announced on September 5, 2025, that it received a No Objection Letter from Health Canada for its Clinical Trial Application to evaluate PALI-2108 in a Phase 1b clinical study for fibrostenotic Crohn’s disease (FSCD). This marks a significant regulatory milestone for the company.
PALI-2108 is positioned as the first dual-acting anti-inflammatory and anti-fibrotic candidate in development for FSCD, a condition for which no approved anti-fibrotic therapies currently exist. Up to half of Crohn’s disease patients develop FSCD, highlighting a critical unmet medical need.
The open-label Phase 1b study is expected to enroll approximately 6-12 patients to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics. Dosing is anticipated to begin in the second half of 2025, with topline data expected in the first quarter of 2026. This progress supports the company's goal of submitting Phase 2 IND applications in the first half of 2026.
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