DENVER, Colo. — September 22, 2026

Palisade Bio announced that the U.S. Food and Drug Administration has cleared the company’s Investigational New Drug (IND) application for PALI-2108, enabling initiation of the Phase 2 ASCENTRA-CD trial in adults with moderate to severe Crohn’s disease. The study is expected to enroll approximately 60 patients, with first patient dosing targeted for Q1 2027 and the primary efficacy readout targeted for Q1 2028. The development program expands PALI-2108 evaluation across inflammatory bowel disease, complementing its ongoing ulcerative colitis program.

ASCENTRA-CD Evaluates PALI-2108 in Crohn’s Disease

ASCENTRA-CD is a multicenter, open-label, single-arm Phase 2 study evaluating the efficacy, safety, pharmacokinetics and pharmacodynamics of once-daily oral PALI-2108. Participants will undergo a 14-day dose-titration period to a target dose of 30 mg once daily, followed by a 12-week induction phase and 36-week maintenance period. The primary endpoint is endoscopic response at Week 12, defined as at least a 50% reduction from baseline in the Simple Endoscopic Score for Crohn’s Disease (SES-CD), based on blinded central endoscopic review.

PALI-2108 Targets the Lower Intestine With a Prodrug Approach

PALI-2108 is an oral PDE4 inhibitor prodrug designed for targeted activation in the terminal ileum and colon, with the goal of generating high local intestinal exposure while maintaining sustained systemic exposure. Palisade said previous Phase 1 clinical experience in healthy volunteers and patients with ulcerative colitis and fibrostenotic Crohn’s disease demonstrated favorable tolerability, targeted tissue exposure, PDE4 target engagement and encouraging biological and endoscopic activity. Key Week 12 secondary endpoints in ASCENTRA-CD will include clinical remission, endoscopic remission, PRO-2 remission, clinical response and combined clinical remission and endoscopic response.

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Palisade Expands Phase 2 IBD Development Program

The ASCENTRA-CD program extends PALI-2108 development across both major forms of inflammatory bowel disease, alongside the ASCENTRA-UC program in ulcerative colitis. Crohn’s disease can cause persistent inflammation, tissue remodeling and fibrosis that may lead to bowel disability, creating continued demand for durable treatment approaches. Palisade expects first patient dosing in Q1 2027 and the primary Week 12 efficacy readout in Q1 2028, with maintenance assessments continuing through Week 48.

Source :Palisade Bio, press release