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First dual-acting anti-inflammatory and anti-fibrotic candidate in development for FSCD, a condition with no approved therapies
Topline safety, PK, and PD data anticipated in Q1 2026
Advances ongoing development of PALI-2108 across fibrostenotic Crohn's disease and ulcerative colitis, with Phase 2 IND submission planned for H1 2026
Palisade Bio, Inc. (NASDAQ:PALI) ("Palisade" or the "Company"), a clinical-stage biopharmaceutical company developing precision therapies for autoimmune, inflammatory, and fibrotic diseases, today announced that the first patients have been dosed in its Phase 1b clinical study evaluating PALI-2108, a first-in-class, ileocolonic-targeted PDE4 inhibitor prodrug, for the treatment of fibrostenotic Crohn's disease (FSCD). Topline data are anticipated in the first quarter of 2026.
"The initiation of patient dosing marks a significant milestone in our mission to address fibrostenotic complications in Crohn's disease, an area with no current approved medical therapies," said Dr. Mitchell Jones, Chief Medical Officer of Palisade Bio. "This mechanistic study is designed to generate critical insights into how PALI-2108 modulates inflammatory and fibrotic pathways in intestinal tissue. Together with data from our ulcerative colitis studies, these findings will inform our planned Phase 2 development and regulatory interactions in 2026."
The open-label, exploratory Phase 1b study will enroll approximately 6 to 12 patients with FSCD. The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of once-daily oral dosing of PALI-2108 over a 14-day treatment period. PALI-2108 is a next-generation phosphodiesterase-4 (PDE4) inhibitor prodrug engineered for targeted activation in the terminal ileum and colon, designed to provide high local tissue exposure with minimal systemic absorption.
In addition to safety and PK/PD assessments, the study will evaluate tissue-level pharmacology and molecular responses using paired ileal biopsies and peripheral blood mononuclear cells (PBMCs). Analyses will include single-nucleus and single-cell RNA sequencing to characterize treatment-induced changes in inflammatory and fibrotic signaling. Exploratory endpoints include endoscopic, histologic, and intestinal ultrasound (IUS) measures to assess structural and inflammatory features of FSCD lesions.
Data from this study, together with results from the Phase 1a/1b ulcerative colitis (UC) program, are expected to support Phase 2 Investigational New Drug (IND) submissions to the U.S. Food and Drug Administration (FDA) in the first half of 2026.
Posted In: PALI