Clinical TrialJun 23, 2026, 04:06 PM
Agomab Aligns with FDA on Phase 2b Study Design for Ontunisertib
AI Summary
Agomab Therapeutics announced regulatory alignment with the U.S. FDA on the design of its Phase 2b NOV-ERA study for ontunisertib, an investigational treatment for Fibrostenosing Crohn’s Disease (FSCD). The study's primary endpoint is endoscopic passability at Week 24. The company expects to initiate the study and dose the first participants in the second half of 2026, with global enrollment of up to 320 adult patients.
Key Highlights
- FDA aligned on key elements of NOV-ERA Phase 2b study design for ontunisertib.
- Primary efficacy endpoint is endoscopic passability at Week 24.
- Study initiation and first participant dosing expected in H2 2026.
- NOV-ERA study to enroll up to 320 adult patients globally.
- Ontunisertib will be administered at 400 mg, 200 mg, or 100 mg, or placebo.
- Ontunisertib has U.S. FDA Fast Track Designation.
Price Impact
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