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Palisade Bio Commences Dosing in First Ulcerative Colitis Patient Cohort in Ongoing Phase 1a/b Study of PALI-2108
Globenewswireยท 2025-03-14 12:30
Core Insights - Palisade Bio, Inc. is advancing its clinical-stage biopharmaceutical product PALI-2108 for the treatment of Ulcerative Colitis, with positive preliminary data from its Phase 1a/b study indicating safety and tolerability [2][4][5] - The company has completed five single ascending dose (SAD) cohorts and the first three of four multiple ascending dose (MAD) cohorts, reporting no serious adverse events (SAEs) or treatment-emergent adverse events (TEAEs) related to laboratory values or EKGs [1][3][4] - Topline data is expected to be reported in the first half of 2025, aligning with management's expectations [4][5] Study Details - The Phase 1a/b study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PALI-2108 in both healthy volunteers and patients with Ulcerative Colitis [5] - Biomarkers such as serum high sensitivity C-reactive protein (hsCRP) and fecal calprotectin (CalPro) will be utilized to assess the drug's effects, alongside histological assessments of colonic tissue [5] - PALI-2108 is a new chemical entity that has not been previously administered to humans, differentiating it from other PDE4 inhibitors that have received market approval [5] Company Overview - Palisade Bio is focused on developing novel therapeutics for patients with autoimmune, inflammatory, and fibrotic diseases, aiming to transform the treatment landscape through targeted approaches [7]