Palisade Bio Begins Dosing in Phase 1 Study of PALI-2108 for Moderate-to-Severe Ulcerative Colitis

In Carlsbad, CA, Palisade Bio, Inc., a biopharmaceutical company listed on Nasdaq under the symbol PALI, has begun its Phase 1 clinical trial of PALI-2108. This compound is an orally administered prodrug of a PDE4 inhibitor, designed for local bioactivation in the colon, targeting patients with ulcerative colitis (UC). This milestone marks the company's transition into a clinical-stage entity, with patient screening currently in progress and initial data expected in the first half of 2025.

The Phase 1 trial is being conducted as a single-center, double-blind, placebo-controlled study, focusing on assessing the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PALI-2108 in both healthy volunteers and UC patients. This study includes several stages: single ascending dose (SAD) cohorts, a crossover study examining the impact of food on PK, multiple ascending dose (MAD) cohorts, and a cohort involving multiple doses in UC patients.

PALI-2108 differs from other PDE4 inhibitors on the market as it represents a new chemical entity not previously tested in humans. Comprehensive safety monitoring and similar PK evaluations will be conducted throughout the study. Biomarker analysis will include serum high sensitivity C-reactive protein (hsCRP), fecal calprotectin (CalPro), and histological assessment of colonic tissue. These biomarkers will provide further insights into the drug's effects and help understand the mechanism and effectiveness of PALI-2108.

Palisade Bio's CEO, JD Finley, emphasized the significance of dosing the first subject, highlighting it as an essential milestone for the company. The primary objective of the trial is to ensure the compound's safety and tolerability, while also assessing its pharmacokinetic and pharmacodynamic properties in both healthy individuals and those with UC.

The trial will involve detailed analysis of colon tissue, including levels of the study drug and its metabolites, PDE4 expression, cyclic adenosine monophosphate (cAMP) levels, and Absolute Lymphocyte Count (ALC), alongside related pharmacodynamic biomarkers. This analysis is crucial for comprehending the drug's mechanism and efficacy.

Palisade Bio is dedicated to developing innovative therapeutics for autoimmune, inflammatory, and fibrotic diseases. The company aims to transform the treatment landscape with its targeted approach. For further details on the Phase 1 clinical trial, individuals can visit clinicaltrials.gov with the reference identifier NCT06663605.

Palisade Bio’s mission focuses on advancing novel therapeutics for patients suffering from autoimmune, inflammatory, and fibrotic conditions. The company is committed to leveraging its targeted approach to make significant improvements in the treatment landscape for these diseases.

In summary, Palisade Bio’s initiation of the Phase 1 clinical trial of PALI-2108 represents a pivotal moment in its evolution into a clinical-stage company. By focusing on the safety, tolerability, and pharmacokinetics of this new chemical entity, the company aims to gather crucial data that could pave the way for new therapeutic options for patients with UC.