Palisade Bio Reports Detailed Positive PALI-2108 Phase 1b Clinical Data, Highlighting Biomarker Normalization

PALI
October 06, 2025

Palisade Bio, Inc. announced on September 17, 2025, new data from its ongoing clinical program for PALI-2108, presented in an oral session at the STAR Consortium Annual Meeting. The data reinforced favorable safety, with no serious adverse events, lab abnormalities, or EKG concerns observed.

The Phase 1b ulcerative colitis (UC) cohort demonstrated a 100% clinical response and promising signals regarding efficacy, with 2 of 5 patients achieving remission after only seven days. These improvements were supported by favorable histology and biomarker changes, confirming local PDE4 engagement and broad immunologic resolution.

Crucially, biomarker analyses showed normalization of 186 genes linked to fibrosis and Crohn’s disease strictures, supporting PALI-2108's translational potential in fibrostenotic Crohn’s disease (FSCD). This highlights the drug's differentiated profile as both an anti-inflammatory and anti-fibrotic therapy.

The company expects patient dosing in the Phase 1b FSCD study to begin in the second half of 2025. Phase 2 Investigational New Drug (IND) submissions are anticipated in the first half of 2026, building on the strong safety and pharmacokinetic profile observed in the Phase 1a study.

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