Business
Palisade Bio Reports Positive Topline Data from Phase 1b Clinical Study of PALI-2108 in Fibrostenotic Crohn’s Disease
PALI-2108 demonstrated favorable safety and tolerability with no serious adverse events after two weeks of treatment in a difficult-to-treat populationPhase
About this update from Palisade Bio, Inc.
[{"type":"text","content":"PALI-2108 demonstrated favorable safety and tolerability with no serious adverse events after two weeks of treatment in a difficult-to-treat populationPhase 1b data demonstrate endoscopic improvement, with a 47.5% reduction in SES-CD score and 40% of patients achieving endoscopic response and 40% of patients achieving endoscopic remissionPharmacokinetic and pharmacodynamic data from ileal tissue and plasma support once-daily oral dosing for Crohn’s disease showing IC90 coverage, with correlation to accepted inflammatory biomarkers Data support expansion into broader luminal CD, an indication that has regulatory clarity, more than doubles the total addressable patient population, and has no anatomical constraintsCompany plans to advance PALI-2108 into a Phase 2 trial in moderate to severe Crohn’s disease, including evaluation of anti-fibrotic effects earlier in the disease courseCompany to host webcast March 31st at 8:00 AM ET – Access the webcast here Carlsbad, CA, March 30, 2026 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a clinical-stage biopharmaceutical company developing next-generation, once-daily, oral PDE4 inhibitor prodrugs designed for targeted delivery to the ileum and colon, today announced positive topline data from its Phase 1b clinical study evaluating PALI-2108, a first-in-class, once-daily oral PDE4 inhibitor prodrug designed to be selectively bioactivated in the ileum and colon, in patients with fibrostenotic Crohn’s disease (FSCD). This Phase 1b study demonstrated favorable safety and tolerability, robust pharmacodynamic target engagement in ileal tissue, and encouraging early signals of clinical activity in the five participating patients. These data support the continued development of PALI-2108 as a potential first therapy designed to address both inflammatory and fibrotic components of Crohn’s disease. “These positive data represent an important step in advancing PALI-2108 as a potential first therapy designed to address fibrostenotic complications in Crohn’s disease,” said Mitch Jones, MD, Ph.D., President & Chief Medical Officer of Palisade Bio. “The favorable safety profile, robust ileal target engagement, and convergence of biomarker and endoscopic improvements reinforce the potential of our once-daily oral PDE4 inhibitor prodrug to modulate both inflammatory an...