Palisade Bio Clears FDA Hurdle for Ulcerative Colitis Drug, Plans Global Phase 2 Trial
Event summary
- Palisade Bio received FDA clearance for its Investigational New Drug (IND) application for PALI-2108, a PDE4 inhibitor prodrug.
- The global Phase 2 ASCENTRA-UC trial will enroll up to 204 patients with moderately to severely active ulcerative colitis across North America and Europe.
- First patient enrollment is anticipated in the second half of 2026, with primary efficacy results expected in the second half of 2027.
- Palisade Bio has partnered with PSI, a leading global contract research organization (CRO) in IBD, to manage the trial execution.
The big picture
Palisade Bio's FDA clearance for PALI-2108 marks a critical step in advancing its inflammatory bowel disease portfolio. The Phase 2 trial initiation comes at a time when the biopharmaceutical industry is increasingly focused on developing targeted therapies for chronic inflammatory conditions. The success of this trial could position Palisade Bio as a key player in the IBD treatment landscape, potentially attracting investment and strategic partnerships.
What we're watching
- Trial Execution
- How Palisade Bio's partnership with PSI will impact the pace and efficiency of the ASCENTRA-UC trial.
- Clinical Efficacy
- Whether PALI-2108 can demonstrate superior efficacy in ulcerative colitis compared to existing treatments.
- Pipeline Expansion
- The timeline for submitting an IND application for ASCENTRA-CD and expanding into Crohn’s disease.
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