Palisade Bio Updates on Phase 1 Clinical Study for Ulcerative Colitis Drug PALI-2108

Palisade Bio, Inc. has announced progress towards launching its Phase 1 clinical trial for PALI-2108, a treatment aimed at ulcerative colitis (UC). The company, specializing in developing therapies for autoimmune, inflammatory, and fibrotic diseases, is making strides with its lead program. PALI-2108 is a locally activated PDE4 inhibitor prodrug designed for patients with moderate to severe UC.

Palisade Bio has utilized advanced machine learning to identify elevated PDE4B expression in more than 1,600 patients across 10 studies, determining that over 70% of these cases involve over-expressing patients. This discovery has the potential to support an FDA-approved test that uses PDE4B expression as a marker for patient enrichment, improving the selection process for UC patients and enhancing the efficacy of the PDE4-inhibiting treatment.

In addition to the PALI-2108 program, Palisade Bio is developing a second approach that involves six PDE4-related biomarkers. This approach has shown superior performance compared to standard tests and is tailored specifically for PDE4 inhibition, aiming to improve therapeutic outcomes. The company is also working on integrating PCR-based assays for potential FDA approval to ensure precise patient targeting.

Palisade Bio's dedication to precision medicine for UC is evident through these advancements, which underscore their commitment to personalized treatment strategies. Such strategies are expected to revolutionize patient care by offering more targeted and effective therapies.

Dr. Mitch Jones, Chief Medical Officer of Palisade Bio, expressed excitement about the progress in developing precision medicine tests and the continued advancement of the PALI-2108 program. He emphasized the challenges faced by UC patients, who require therapies that ensure effective remission rates, are non-immunosuppressive, and have improved safety profiles. Dr. Jones affirmed the company's adherence to its clinical and regulatory timeline, aiming to initiate the Phase 1 study before the end of the year.

The company has submitted a Clinical Trial Application (CTA) for its Phase 1 study of PALI-2108. This study will be a single-center, double-blind, placebo-controlled trial focusing on safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers, as well as an open-label study involving UC patients. Previously, the company established dose levels and the trial design, planning to enroll approximately 90 patients across various cohorts, including SAD, FE, MAD, and UC. The primary goal is to assess the safety and tolerability of single and repeated oral doses of PALI-2108. Secondary objectives include evaluating the pharmacokinetics of PALI-2108 and its metabolites in plasma, urine, and feces, and determining the impact of food on the pharmacokinetics of PALI-2108 and its metabolites.

Recently, Palisade Bio held a pre-CTA consultation with Health Canada to present its SAD-MAD-FE Phase 1 program for PALI-2108 in healthy volunteers. This meeting aimed to understand Health Canada's clinical study design expectations and regulations, which facilitated the submission of the CTA for the Phase 1 study.

Palisade Bio remains committed to developing and advancing novel therapeutics that can transform the treatment landscape for patients with autoimmune, inflammatory, and fibrotic diseases. Through a targeted approach with its innovative therapies, the company aims to make significant strides in patient care.