Palisade Bio, Inc. (Nasdaq: PALI) announced today that the first patients have been dosed in its Phase 1b clinical study evaluating PALI‑2108, a gut‑restricted phosphodiesterase‑4 (PDE4) inhibitor prodrug, for the treatment of fibrostenotic Crohn’s disease (FSCD). The study, based in Carlsbad, California, marks the first human exposure of the drug in the target patient population.
The open‑label, exploratory Phase 1b study will enroll approximately 6 to 12 patients and administer once‑daily oral dosing over a 14‑day treatment period. The primary objectives are to assess safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of PALI‑2108 in FSCD patients.
The study will also evaluate tissue‑level pharmacology and molecular responses using paired ileal biopsies and peripheral blood mononuclear cells (PBMCs). Exploratory endpoints include endoscopic, histologic, and intestinal ultrasound measures to assess structural and inflammatory features of FSCD lesions.
PALI‑2108 is a first‑in‑class, ileocolonic‑targeted prodrug designed to deliver a PDE4 inhibitor directly to the terminal ileum and colon, aiming to provide anti‑inflammatory and anti‑fibrotic effects while minimizing systemic exposure. This milestone advances the company’s lead program in an indication where no approved anti‑fibrotic therapies currently exist.
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