Palisade Bio Receives FDA Clearance of IND for PALI-2108 and Plans to Initiate Global Phase 2 ASCENTRA-UC Study in Ulcerative Colitis
Palisade Bio received FDA clearance of its IND application for PALI-2108, enabling the initiation of the global Phase 2 ASCENTRA-UC study in patients with moderately to severely active ulcerative colitis. The multicenter, double-blind trial expects to enroll approximately 204 patients across North America and Europe to evaluate two once-daily dose levels versus placebo.
Key figures
- Drug Name
- PALI-2108
- Phase Of Trial
- Phase 2
- Dosing levels
- 15 mg and 30 mg
- Primary endpoint
- clinical remission at Week 12
- Enrollment target
- 204
- Primary readout timeline
- second half of 2027
AI analysis
The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.
AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.