DENVER, Colo., June 29, 2026
Palisade Bio, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for PALI-2108, allowing the company to begin the global Phase 2 ASCENTRA-UC clinical trial in patients with moderately to severely active ulcerative colitis (UC). The milestone marks a significant advancement for the company’s inflammatory bowel disease pipeline and follows encouraging Phase 1 clinical results demonstrating favorable safety, tolerability, pharmacokinetics, and pharmacodynamics. Palisade Bio expects to initiate patient enrollment during the second half of 2026, with primary efficacy results anticipated in the second half of 2027.
Global Phase 2 ASCENTRA-UC Trial Designed to Evaluate Efficacy and Safety
The ASCENTRA-UC study is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase 2 clinical trial expected to enroll approximately 204 patients across North America and Europe. The study will evaluate two once-daily oral doses of PALI-2108 (15 mg and 30 mg) against placebo in adults with moderately to severely active ulcerative colitis. The primary endpoint is clinical remission at Week 12, measured using the modified Mayo Score. Important secondary endpoints include clinical response, endoscopic improvement, and histologic-endoscopic mucosal improvement (HEMI). Patients who complete the 12-week induction phase and meet eligibility criteria will continue into a 36-week maintenance period, enabling researchers to assess the durability of treatment response through Week 48.
Novel PDE4 Prodrug Targets Localized Treatment for Inflammatory Bowel Disease
According to Palisade Bio, PALI-2108 is a once-daily oral PDE4 inhibitor prodrug engineered to become selectively activated within the terminal ileum and colon, delivering localized anti-inflammatory activity while supporting systemic pharmacokinetics suitable for chronic therapy. The company believes this targeted bioactivation strategy could improve tolerability while maintaining therapeutic efficacy for patients with inflammatory bowel diseases. Dr. Mitch Jones, President and Chief Medical Officer of Palisade Bio, described the FDA clearance as a major milestone validating the extensive preclinical, manufacturing, and clinical work supporting the program. He noted that the differentiated prodrug design may provide a new oral treatment option for patients with inflammatory bowel disease. To support the execution of the international study, Palisade Bio has partnered with PSI, a global contract research organization recognized for its experience in Phase 2 and Phase 3 gastroenterology and immunology clinical trials.
Advertisement
Pipeline Expansion Continues Beyond Ulcerative Colitis
Beyond the ASCENTRA-UC program, Palisade Bio is also advancing ASCENTRA-CD, a clinical development program targeting Crohn’s disease. The company expects to submit an IND application for this study during the second half of 2026, reflecting its strategy to expand PALI-2108 across multiple inflammatory bowel disease indications. Supported by positive Phase 1a and Phase 1b studies in ulcerative colitis and fibrostenotic Crohn’s disease, the program aims to establish PALI-2108 as a differentiated oral therapy capable of delivering targeted gastrointestinal treatment while improving convenience and long-term tolerability. With FDA authorization now secured, Palisade Bio enters a critical stage of development that could significantly strengthen its position in the inflammatory bowel disease treatment landscape.
Source: Palisade Bio, press release
