Agomab Therapeutics Doses First Patient In NOV-ERA, Global Phase 2b Study Evaluating Ontunisertib In Patients With Symptomatic FSCD

Agomab Therapeutics has initiated the NOV-ERA global Phase 2b study, dosing the first patient to evaluate ontunisertib in approximately 320 patients with symptomatic Fibrostenosing Crohn's disease (FSCD). This randomized, double-blind, placebo-controlled study will assess the safety and efficacy of three dose levels of ontunisertib over a treatment duration of 52 weeks, with endoscopic passability at Week 24 as the primary endpoint. The study follows positive results from the Phase 2a STENOVA study, which support the continued development of ontunisertib as a potential targeted anti-fibrotic treatment for FSCD.