Palisade Bio Announces First Patients Dosed in Phase 1b Study of Oral First-In-Class PDE4 Inhibitor Prodrug, PALI-2108, for the Treatment of Fibrostenotic Crohn's Disease (FSCD)

Core Insights - Palisade Bio has initiated a Phase 1b clinical study for PALI-2108, a first-in-class PDE4 inhibitor prodrug targeting fibrostenotic Crohn's disease (FSCD), with topline data expected in Q1 2026 [2][3][5] Group 1: Clinical Development - The Phase 1b study will enroll approximately 6 to 12 patients and aims to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PALI-2108 over a 14-day treatment period [3][4] - PALI-2108 is designed for targeted activation in the terminal ileum and colon, providing high local tissue exposure with minimal systemic absorption [3][6] - The study will also assess tissue-level pharmacology and molecular responses using paired ileal biopsies and peripheral blood mononuclear cells (PBMCs) [4] Group 2: Future Plans - Data from the Phase 1b study, along with results from the Phase 1a/1b ulcerative colitis program, are expected to support Phase 2 Investigational New Drug (IND) submissions to the FDA in the first half of 2026 [5] - The company aims to transform the treatment landscape for autoimmune, inflammatory, and fibrotic diseases through its targeted therapeutic approach [7]