USFDAJun 29, 2026, 08:32 AM
Palisade Bio gets FDA IND clearance for PALI-2108 Phase 2 UC trial
AI Summary
Palisade Bio announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for PALI-2108. This clearance enables the initiation of the global Phase 2 ASCENTRA-UC clinical trial for patients with moderately to severely active ulcerative colitis. The company expects to begin patient enrollment in the second half of 2026, with primary efficacy results anticipated in the second half of 2027. Additionally, Palisade Bio plans to submit an IND for ASCENTRA-CD for Crohn's disease in the second half of 2026 and has partnered with PSI for the ASCENTRA-UC trial execution.
Key Highlights
- FDA cleared IND application for PALI-2108, enabling Phase 2 ASCENTRA-UC clinical trial.
- ASCENTRA-UC trial to enroll up to 204 patients with moderately to severely active ulcerative colitis.
- Patient enrollment for ASCENTRA-UC is anticipated in the second half of 2026.
- Primary efficacy results for ASCENTRA-UC are expected in the second half of 2027.
- Palisade Bio plans to submit an IND for ASCENTRA-CD (Crohn's disease) in H2 2026.
- Company partnered with PSI, a CRO, to manage the execution of the ASCENTRA-UC program.
Price Impact
More from PALI