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PALI-2108 demonstrated favorable safety, with no serious adverse events, lab abnormalities, or EKG concerns
Phase 1b data demonstrated 100% clinical response and promising signals regarding the efficacy of PALI-2108 in ulcerative colitis (UC) using FDA-defined endpoints
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 2H 2025; Phase 2 IND submissions anticipated in 1H 2026
Palisade Bio, Inc. (NASDAQ:PALI) ("Palisade," "Palisade Bio," or the "Company"), a clinical-stage biopharmaceutical company developing precision therapies for autoimmune, inflammatory, and fibrotic diseases, today announced new data from its ongoing clinical program evaluating PALI-2108, a first-in-class, ileocolonic-targeted PDE4 B/D inhibitor. The results are to be presented in an oral session at the STAR Consortium Annual Meeting – the accompanying slides are now available here.
The Phase 1b UC cohort demonstrated rapid and consistent clinical activity, with all patients responding to treatment. While the study was shorter in duration than standard induction trials and not powered for efficacy, there was promising signals of clinical improvement, with 2 of 5 patients achieving remission after only seven days. These improvements were reinforced by favorable histology and biomarker changes that confirmed local PDE4 engagement and broad immunologic resolution. Together with the strong safety and PK profile observed in the Phase 1a study, the results highlight PALI-2108's differentiated potential as both an anti-inflammatory and anti-fibrotic therapy.
Posted In: PALI
