Health Canada Approves Palisade Bio's Phase 1 Study for Ulcerative Colitis Treatment

Palisade Bio, Inc. (Nasdaq: PALI), a biopharmaceutical firm concentrating on innovative treatments for autoimmune, inflammatory, and fibrotic diseases, announced that it has received a No Objection Letter from Health Canada. This letter is in response to Palisade Bio’s Clinical Trial Application (CTA) for a Phase 1 study of PALI-2108, designed to treat ulcerative colitis (UC).

J.D. Finley, CEO of Palisade Bio, expressed excitement about the milestone, emphasizing the importance of PALI-2108 for UC patients who are in need of effective and safe treatments. He reiterated the company’s confidence in PALI-2108's potential to be the pioneering PDE4 inhibitor approved for UC, highlighting the team's focus on initiating the Phase 1 clinical trial by the end of the year.

PALI-2108 is an orally administered PDE4 inhibitor prodrug, specifically activated in the colon. The Phase 1 study aims to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers, along with a cohort of UC patients. The study is structured as a single-center, double-blind, placebo-controlled trial. An additional open-label study will be conducted with UC patients. Approximately 90 participants are expected to be enrolled across different cohorts, including those receiving single ascending doses (SAD), multiple ascending doses (MAD), and food effect (FE) assessments.

Dr. Florian Rieder, a member of the Palisade Bio Clinical Advisory Board and a prominent gastroenterologist at the Cleveland Clinic, emphasized the urgent need for new UC treatments. He noted that current therapies often fail to induce complete remission in most patients and that many effective treatments entail injections or carry serious side effects. An effective oral medication like PALI-2108 would be a significant advancement for UC patients.

The primary aim of the study is to determine the safety and tolerability of single and repeated doses of PALI-2108 in both healthy subjects and UC patients. Secondary objectives include analyzing the pharmacokinetics of PALI-2108 and its metabolites through plasma, urine, and fecal samples, and assessing the impact of food on the pharmacokinetics of the drug in healthy individuals. Exploratory objectives will focus on PDE4-related biomarkers, active concentrations of PALI-2108, high sensitivity C-reactive protein (hsCRP), fecal calprotectin (CalPro), colonic tissue Absolute Lymphocyte Count (ALC), Modified Mayo score, and histological changes in UC patients.

The preparations for the clinical trial are progressing, with site initiation and patient enrollment expected to begin before the end of the year.

Palisade Bio’s mission is to advance the treatment of autoimmune, inflammatory, and fibrotic diseases through innovative therapeutics. They aim to make significant improvements in the treatment landscape for these conditions.