Agomab Therapeutics Announces Phase 2b NOV-ERA Study Design for Ontunisertib

Agomab Therapeutics NV announced the design of its upcoming Phase 2b NOV-ERA study for ontunisertib, an investigational oral ALK5 inhibitor for Fibrostenosing Crohn’s Disease (FSCD). The company has aligned with the FDA on the study design, including the primary efficacy endpoint, and has received approvals from Health Canada and central IRB in the U.S. The randomized, double-blind, placebo-controlled trial will enroll up to 320 adult patients globally, with the first participants expected to be dosed in the second half of 2026. Ontunisertib, which has U.S. FDA Fast Track Designation, addresses a significant unmet medical need as there are no approved pharmacological therapies for FSCD.