Palisade Bio, Inc. announced on August 7, 2025, compelling new data from its clinical program for PALI-2108, including positive topline results from its Phase 1b open-label cohort in patients with moderate-to-severe ulcerative colitis (UC). The study demonstrated a 100% clinical response rate in the five enrolled patients.
PALI-2108 was shown to be safe and well tolerated, with over 95% of treatment-emergent adverse events (TEAEs) rated as mild and transient, and no serious adverse events (SAEs) or discontinuations. Colon tissue drug levels in the Phase 1a multiple ascending dose (MAD) cohort exceeded target thresholds 36 hours post-dose, supporting convenient once-daily dosing.
Mechanistically, colon tissue analyses confirmed PDE4 inhibition and immunomodulation, with robust histologic improvements and a marked reduction in tissue lymphocytes. These results, combined with targeted delivery and dose flexibility, position PALI-2108 as a potentially best-in-class oral therapy for UC. The company plans to complete a Phase 1b study in fibrostenotic Crohn’s disease by the second half of 2025 and submit a Phase 2 Investigational New Drug (IND) application in the first half of 2026.
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