PALI-2108 - (ASCENTRA-CD)

September 22, 2026: Palisade Bio, Inc. (NASDAQ: PALI) said the FDA cleared the IND for PALI-2108, allowing initiation of the Phase 2 ASCENTRA-CD trial in moderate to severe Crohn’s disease. ASCENTRA-CD is a multicenter, open-label, single-arm study planned to enroll about 60 adults. Patients will titrate over 14 days to PALI-2108 30 mg orally once daily, with a 12-week induction phase and 36-week maintenance phase.

The primary endpoint is Week 12 endoscopic response, defined as at least a 50% reduction from baseline in SES-CD by blinded central review. Key Week 12 secondary endpoints include clinical remission, endoscopic remission, PRO-2 remission, clinical response, and combined clinical remission plus endoscopic response, with maintenance assessments through Week 48.

First patient dosing is targeted for Q1 2027 and the primary efficacy readout for Q1 2028.

PALI-2108 is a once-daily oral PDE4 inhibitor prodrug designed for activation in the terminal ileum and colon. The company said prior Phase 1 work in healthy volunteers and patients with ulcerative colitis and fibrostenotic Crohn’s disease showed favorable safety/tolerability, differentiated pharmacokinetics, sustained PDE4 inhibition above IC90, tissue exposure, target engagement, and encouraging endoscopic activity. The release also notes Phase 2 development is advancing in both Crohn’s disease and ulcerative colitis, including ASCENTRA-UC.