Palisade Bio Reports Positive Preclinical Data For PALI-2108 In Treatment Of Ulcerative Colitis

As a clinical-stage biopharmaceutical enterprise, Palisade Bio, Inc. concentrates on developing pharmaceutical treatments for immune disorders, inflammation, and fibrotic diseases. The firm recently revealed the successful preclinical data from PALI-2108. The company has created this oral prodrug treatment as a colon-specific phosphodiesterase-4 (PDE4) inhibitor for ulcerative colitis (UC) patients. The data were presented at the Crohn’s & Colitis Congress in San Francisco, CA, in a poster titled “PALI-2108, a Colon-Specific PDE4B Inhibitor Prodrug, Reduces Ulcerative Colitis Symptoms in an Acute Colitis DSS Mouse Model.”

Mitch Jones, MD, PhD, Chief Medical Officer of Palisade Bio, stated, “UC patients need new oral therapies with higher remission rates, less systemic immunosuppression, and a strong safety profile. We continue to be encouraged by our preclinical and clinical results for PALI-2108, and we believe PALI-2108 could be an important option for these patients. We are on track to report topline data in the first half of 2025 and are excited to continue exploring this novel, oral, intestinally activated PDE4 inhibitor.”

In preclinical studies, mice with induced colitis treated with PALI-2108 twice daily for three days showed reduced disease activity compared to those treated with tacrolimus and apremilast. Drug levels were measured in plasma, duodenum, ileum, and colon tissues, with PDE4 binding confirmed through Cellular Thermal Shift Assay (CETSA). 

Pharmacokinetic modelling in UC patients and healthy volunteers indicated favourable absorption and bioavailability, supporting its clinical potential. Palisade Bio is conducting a Phase 1a/b study to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers, along with an open-label study in UC patients.