Agomab Announces First Patient Dosed in Global NOV-ERA Phase 2b Study of Ontunisertib in Fibrostenosing Crohn's Disease
Globe Newswire•13/10/2026•16:05 ET
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Key Highlights
- ➤Agomab doses first patient in global Phase 2b NOV-ERA study of ontunisertib
- ➤NOV-ERA plans approximately 320 patients across three ontunisertib doses and placebo
- ➤Study initiation triggers €7 million milestone payment to former Origo shareholders
- ➤Ontunisertib received U.S. FDA Fast Track Designation
Expert Statements
Philippe Wiesel, Chief Medical Officer of Agomab
“Dosing the first patient in NOV-ERA marks the beginning of an exciting next chapter for our Company and for the late-stage development of ontunisertib. FSCD is associated with progressive bowel damage and a substantial burden for patients; yet there are currently no approved therapies that specifically address the fibrotic component of the disease. NOV-ERA is designed to evaluate the efficacy and safety of ontunisertib and to provide important data across multiple imaging modalities, clinical endpoints, and patient-reported outcomes. We are grateful to the patients, investigators and clinical sites participating in this global study.”
-- NOV-ERA is designed to assess the efficacy and safety of ontunisertib in approximately 320 patients with symptomatic Fibrostenosing Crohn's disease (FSCD) --
-- Global, randomized, placebo-controlled, dose-ranging study to evaluate three dose levels of ontunisertib, with endoscopic passability at Week 24 as primary endpoint --
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