Palisade Bio, Inc. announced on April 9, 2025, the completion of enrollment and dosing in all five Phase 1a single ascending dose (SAD) cohorts, all four multiple ascending dose (MAD) cohorts, and the food effects crossover. This marks the completion of the Phase 1a portion of its ongoing Phase 1a/b study of PALI-2108 for ulcerative colitis (UC).
Preliminary results from these cohorts showed no serious adverse events (SAEs) or treatment-emergent adverse events (TEAEs) related to laboratory values or EKGs. The majority of observed TEAEs were mild, with only one withdrawal in the highest 50 mg twice-daily MAD cohort.
The company highlighted PALI-2108's excellent tolerability at comparable dose levels, given its high potency towards PDE4 B and D in preclinical studies. Screening and dosing for the Phase 1b UC patient cohort are ongoing, and Palisade Bio remains on track to report topline data from the Phase 1a portion by the end of May 2025.
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