Palisade Bio Gains FDA IND Clearance for PALI-2108, Launches 204-Patient Phase 2 Trial
PALI•FDA cleared the IND for PALI-2108, enabling a 204-patient global Phase 2 ASCENTRA-UC trial in ulcerative colitis across North America and Europe. Patient enrollment is set for H2 2026 with primary efficacy readout expected in H2 2027, and an IND for a Crohn’s disease program is planned in H2 2026.
1. FDA Clearance of PALI-2108 IND
On June 29, 2026, the FDA cleared the IND application for PALI-2108, enabling Phase 2 development in moderately to severely active ulcerative colitis. The decision reflects robust preclinical and Phase 1 safety, tolerability and pharmacology results, validating advancement of the program.
2. ASCENTRA-UC Phase 2 Trial Design
ASCENTRA-UC is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study expected to enroll 204 patients across North America and Europe. Two once-daily doses (15 mg and 30 mg) will be evaluated versus placebo, with Week 12 clinical remission as the primary endpoint and data due in H2 2027.
3. Pipeline Expansion and Crohn’s Program
In parallel, Palisade Bio plans to submit an IND for the ASCENTRA-CD Crohn’s disease trial in H2 2026, leveraging PALI-2108’s localized PDE4 inhibition across IBD indications. The company has engaged PSI to manage global trial execution and regulatory coordination.
