Palisade Bio (PALI) announced new data from its ongoing clinical program evaluating PALI-2108, a first-in-class, ileocolonic-targeted PDE4 B/D inhibitor. Phase 1a Safety and Pharmacokinetics: No serious adverse events and no lab or EKG abnormalities observed. Well tolerated at single doses up to 450 mg and multiple BID doses up to 50 mg. Extended half-life and colon-targeted bioactivation support once-daily dosing. Phase 1b Ulcerative Colitis Cohort: All patients showed a clinical response as measured by modified Mayo score. Two of the 5 patients achieved clinical remission based on FDA-defined endpoints. 62.8% mean reduction in modified Mayo score. Translational Relevance to FSCD: 186 fibrotic gene markers elevated at baseline in UC patients were reduced at endpoint. Data support anti-fibrotic potential of PALI-2108 in FSCD.
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