Palisade Bio Receives FDA Clearance of IND for PALI-2108 and Plans to Initiate Global Phase 2 ASCENTRA-UC Study in Ulcerative Colitis

About this update from Palisade Bio, Inc.

ASCENTRA-UC expected to enroll up to 204 patients with moderately to severely active ulcerative colitis across North America and Europe First patient enrollment anticipated in the second half of 2026; primary efficacy results expected in the second half of 2027 IND clearance marks a major development milestone for PALI-2108 and supports continued advancement of the Company's inflammatory bowel disease portfolio Denver, CO, June 29, 2026 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) ("Palisade" or the "Company"), a clinical-stage biopharmaceutical company developing next-generation oral PDE4 inhibitor prodrugs for inflammatory bowel disease, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for PALI-2108, enabling initiation of the global Phase 2 ASCENTRA-UC clinical trial in patients with moderately to severely active ulcerative colitis (UC). The Company anticipates initiating patient enrollment in the second half of 2026, with primary efficacy results expected in the second half of 2027. "FDA clearance of our IND application is a significant milestone for Palisade Bio and an important validation of the extensive preclinical, manufacturing and clinical work completed to advance PALI-2108 into Phase 2 development," said Mitch Jones, M.D., Ph.D., President and Chief Medical Officer of Palisade Bio. "We believe PALI-2108's novel prodrug design and targeted local bioactivation profile may offer a differentiated oral approach for patients living with inflammatory bowel disease. Supported by encouraging Phase 1 data in both ulcerative colitis and fibrostenotic Crohn's disease, we look forward to entering what we believe will be a value-defining stage of development for the program." ASCENTRA-UC Phase 2 Trial Design ASCENTRA-UC is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase 2 clinical trial designed to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of PALI-2108 in patients with moderately to severely active ulcerative colitis. The study is expected to enroll approximately 204 patients and evaluate two once-daily dose levels of PALI-2108, 15 mg and 30 mg, compared with placebo. The primary endpoint is clinical remission at Week 12, as measured by the modified Mayo Score. Key secondary endpoints include clinical resp...

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