Palisade Bio, Inc. announced on May 27, 2025, positive topline results from its completed Phase 1 studies of PALI-2108. The studies, which included single ascending dose (SAD), multiple ascending dose (MAD), and cross-over food effect (FE) cohorts in healthy volunteers, successfully met their primary endpoints of safety, tolerability, and pharmacokinetics (PK).
No serious adverse events (SAEs) or treatment-emergent adverse events (TEAEs) related to laboratory values or EKGs were observed across the SAD/MAD cohorts. This data validates PALI-2108’s targeted prodrug design, demonstrating that the drug reaches therapeutic concentrations in the colon with lower systemic exposure.
Based on these results, Palisade Bio plans to initiate an additional safety, tolerability, and PK/PD exploratory Phase 1b cohort in fibrostenotic Crohn’s disease (FSCD). This will be followed by the initiation of Phase 2 clinical programs to assess PALI-2108’s efficacy, safety, and tolerability in patients with both FSCD and moderate-to-severe ulcerative colitis (UC).
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