Palisade Bio (NASDAQ: PALI) has announced new data from its ongoing clinical program evaluating PALI-2108, a first-in-class, ileocolonic-targeted PDE4 B/D inhibitor. The company plans to present the results in an oral session at the STAR Consortium Annual Meeting.
According to Palisade, PALI-2108 demonstrated favourable safety, with no serious adverse events, lab abnormalities, or EKG concerns. Phase 1b data showed 100% clinical response and promising signals regarding the efficacy of PALI-2108 in ulcerative colitis, using FDA-defined enpoints. Biomarker analyses showed normalization of 186 genes linked to fibrosis and Crohn’s disease strictures, supporting translational potential in fibrostenotic Crohn’s disease (FSCD). Patient dosing in the Phase 1b FSCD study is expected to begin in Q2 2025 with Phase 2 IND submissions anticipated in Q1 2026.
In a statement, JD Finley, CEO of Palisade, commented, “These results highlight the differentiated profile of PALI-2108, demonstrating strong safety, rapid clinical activity, and broad biomarker engagement in ulcerative colitis, while reinforcing its potential as the first targeted anti-fibrotic therapy in Crohn’s strictures. We are excited to advance this program into its next stage of development as we prepare for Phase 2.”
