Palisade Bio, Inc. (NASDAQ: PALI) has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for PALI-2108, enabling the initiation of the global Phase 2 ASCENTRA-UC clinical trial. The trial targets patients with moderately to severely active ulcerative colitis (UC), a significant step in advancing the company's inflammatory bowel disease portfolio. Patient enrollment is anticipated to begin in the second half of 2026, with primary efficacy results expected in the second half of 2027.

The ASCENTRA-UC trial is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study designed to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of PALI-2108. The study aims to enroll approximately 204 patients across North America and Europe, comparing two once-daily dose levels (15 mg and 30 mg) against placebo. The primary endpoint is clinical remission at Week 12, measured by the modified Mayo Score, with key secondary endpoints including clinical response, endoscopic improvement, and histologic-endoscopic mucosal improvement (HEMI).

Following the 12-week induction period, eligible patients will continue into a 36-week maintenance phase to assess the durability of response through Week 48. To support the trial's execution, Palisade Bio has partnered with PSI, a global contract research organization (CRO) specializing in immunology and gastroenterology.

PALI-2108 is a once-daily oral PDE4 inhibitor prodrug designed for selective bioactivation in the terminal ileum and colon, offering a localized gastrointestinal activity profile. Positive Phase 1 data have demonstrated encouraging safety, tolerability, and pharmacokinetic results, supporting further clinical development. In parallel, the company plans to submit an IND application for ASCENTRA-CD, targeting Crohn's disease, in the second half of 2026.

ASCENTRA-UC Trial Details

Pipeline Expansion

Palisade Bio is advancing its inflammatory bowel disease portfolio with plans to submit an IND application for ASCENTRA-CD in the second half of 2026. The company believes PALI-2108's broad applicability across inflammatory bowel disease indications may provide opportunities for expansion beyond ulcerative colitis.

Palisade Bio, Inc. has appointed Robert Baltera and Jordan Zwick to its Board of Directors, strengthening the board with expertise in biotechnology leadership, strategic transactions, and capital markets. The clinical-stage biopharmaceutical company is advancing its lead program, PALI-2108, a once-daily oral PDE4 inhibitor prodrug, toward Phase 2 development for inflammatory bowel disease. The new directors are expected to support the company's clinical progress and long-term growth strategy.

Board Expertise and Strategic Value

JD Finley, Chief Executive Officer of Palisade Bio, stated that the combined expertise of Baltera and Zwick in biotechnology company building, strategic transactions, and corporate governance will provide meaningful value. Both executives have significant experience supporting innovative biotechnology companies through development, financing, and value creation stages.

Robert Baltera

Mr. Baltera is a Senior Advisor at Frazier Life Sciences with over three decades of experience. He previously served as Chief Executive Officer and Board Director of Cirius Therapeutics and currently serves on the Board of Directors of Inipharm. His past roles include Chief Executive Officer of Amira Pharmaceuticals, which was sold to Bristol-Myers Squibb in 2011 for $475 million, and Chairman of Mavupharma until its acquisition by AbbVie. He also served on the boards of Frazier Lifesciences Acquisition Corporation and Imago BioSciences, acquired by Merck. Earlier in his career, he held senior management positions at Amgen during a 17-year tenure.

Jordan Zwick

Mr. Zwick is the Co-Founder and Chief Business Officer of Mirador Therapeutics. He has advised on strategic transactions, including serving as a strategic advisor to Prometheus Biosciences prior to its acquisition by Merck in 2023 and to CrossBridge Bio through its acquisition by Eli Lilly in 2026. He was a member of the Board of Directors and Audit Committee of Theratechnologies, Inc. prior to its sale to Future Pak in 2025. Previously, he served as Senior Vice President, Corporate Business Development and Investor Relations at Amarin Corporation and as Senior Vice President and Chief Strategy Officer at InflaRx N.V. He currently serves on the Board of Directors of TruTechnologies and on the Advisory Board of the McKenna Life Sciences Program at Arizona State University.

Advancing PALI-2108

The appointments coincide with Palisade Bio's advancement of PALI-2108 toward Phase 2 clinical studies in ulcerative colitis and Crohn's disease. The program has generated positive clinical data from a Phase 1a trial and two Phase 1b clinical trials. The company is focused on transforming proven PDE4 biology into differentiated oral therapies for chronic inflammatory and fibrotic diseases.