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

-- 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 --

-- Study initiation represents an important milestone in the development of ontunisertib as a potential first targeted anti-fibrotic treatment for FSCD --

Antwerp, Belgium, October 13, 2026 – Agomab Therapeutics NV (‘Agomab’), a clinical-stage biopharmaceutical company focused on fibro-inflammation, today announced that the first patient has been dosed in NOV-ERA, the Company's global Phase 2b study evaluating ontunisertib in patients with symptomatic FSCD.

NOV-ERA is a randomized, double-blind, placebo-controlled, multicenter Phase 2b study designed to assess the safety and efficacy of ontunisertib. The study is expected to enroll approximately 320 adult patients globally. Participants will be randomized to receive either ontunisertib at one of three dose levels (400 mg BID, 200 mg BID, and 100 mg BID), or a matching placebo for a treatment duration of 52 weeks.

The initiation of NOV-ERA follows the positive Phase 2a STENOVA results that support continued clinical development of ontunisertib in FSCD. The recently announced positive long-term safety and tolerability findings of the open-label extension (OLE) part of the STENOVA Phase 2a study provide strong support for the inclusion of a 400 mg BID treatment arm in the NOV-ERA study.