Agomab Doses First Patient in NOV-ERA Phase 2b FSCD Study


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Agomab Announces First Patient Dosed in Global NOV-ERA Phase 2b Study of Ontunisertib in Fibrostenosing Crohn's Disease
Antwerp, Belgium, October 13, 2026 - Agomab Therapeutics NV announced that the first patient has been dosed in NOV-ERA, its global Phase 2b study evaluating ontunisertib in patients with symptomatic fibrostenosing Crohn's disease (FSCD).
NOV-ERA is a randomized, double-blind, placebo-controlled, multicenter trial designed to assess the safety and efficacy of ontunisertib in approximately 320 adult patients globally. Participants are assigned to receive one of three dose levels of ontunisertib or a matching placebo for a treatment duration of 52 weeks.
Study Highlights
- Evaluation of three dose levels: 400 mg BID, 200 mg BID, and 100 mg BID.
- Primary endpoint is endoscopic passability of the ileal index stricture at Week 24.
- Study initiation triggers a EUR 7 million milestone payment under Agomab's previous acquisition terms.
About Agomab Therapeutics NV
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