Palisade Bio Reports Phase 1 Data Showing PALI-2108 Safe for Ulcerative Colitis

Carlsbad, CA, Dec. 03, 2024 – Palisade Bio, Inc. (Nasdaq: PALI), a clinical-stage biopharmaceutical firm, has announced initial results from the first three single ascending dose (SAD) cohorts in its Phase 1 clinical trial for PALI-2108, a treatment option for Ulcerative Colitis (UC). The study, conducted at a single center, double-blind and placebo-controlled, aims to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PALI-2108 in healthy volunteers and UC patients.

Preliminary data indicate that PALI-2108 is safe and well-tolerated at 15mg, 50mg, and 150mg doses, showing no treatment-related dose reductions or adverse events. The cohorts, comprising 24 participants (with a 6:2 active to placebo ratio), reported no treatment-related adverse events (TRAEs), serious adverse events (SAEs), or lab abnormalities. Initial PK results display delayed release of the PDE4 inhibitor, suggesting that PALI-2108 is effectively activated in the colon.

Following these promising findings, Palisade Bio plans to proceed with a crossover study to examine the impact of food on PK, followed by multiple ascending dose (MAD) cohorts and a multiple dose cohort involving UC patients. These cohorts will undergo comprehensive safety monitoring and similar PK evaluations.

The primary goal of this Phase 1 study is to evaluate the safety, tolerability, and PK of PALI-2108 in healthy volunteers and UC patients. While several PDE4 inhibitors have been approved for inflammatory and fibrotic diseases, PALI-2108 is a novel chemical entity being tested in humans for the first time. The study employs biomarkers such as serum high sensitivity C-reactive protein (hsCRP) and fecal calprotectin (CalPro), along with histological assessments of colonic tissue, to gain deeper insights into the drug's effects.

Analysis of colon tissue will include assessments of the study drug and its metabolites, PDE4 expression, cyclic adenosine monophosphate (cAMP) levels, Absolute Lymphocyte Count (ALC), and related PD biomarkers. These evaluations are crucial for understanding PALI-2108's mechanism and efficacy.

Palisade Bio is set to report topline data from this study in the first half of 2025. For detailed information about the Phase 1 clinical study, reference identifier NCT06663605 at clinicaltrials.gov.

About PALI-2108:
PALI-2108 is an orally administered, colon-specific PDE4 inhibitor prodrug designed for UC patients. The comprehensive data collected from this study aims to support Palisade Bio’s precision medicine strategy, focusing on identifying patient responders for future clinical trials.

About Palisade Bio:
Palisade Bio is a clinical-stage biopharmaceutical company dedicated to developing innovative therapeutics for autoimmune, inflammatory, and fibrotic diseases. The company aims to revolutionize the treatment landscape through targeted approaches with its novel therapeutics.