Agomab Therapeutics Reported Positive STENOVA Study Results
The Phase 2a extension study found high remission rates for patients with fibrostenosing Crohn's disease.
Updated on Oct. 1, 2026 in Biotech
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Agomab Therapeutics has released positive topline data from its STENOVA Phase 2a open-label extension study of the drug ontunisertib. The treatment showed promising results in addressing bowel fibrosis in patients with fibrostenosing Crohn's disease.
Why it matters
Ontunisertib aims to address bowel fibrosis by inhibiting ALK5 and TGF-beta in the gastrointestinal tract. These results provide critical support for expanding the treatment regimen in upcoming global clinical trials.
Patients received 200 mg of ontunisertib twice daily, with 97% achieving clinical remission by Week 48. The study recorded an annualized fibrostenosing Crohn's disease-related event rate of 3% across 49 participants.
The players
Agomab Therapeutics
A biotech company headquartered in Antwerp, Belgium, focused on developing therapies to modulate fibrosis and regenerate damaged tissue.
The details
The study observed radiological stabilization of fibrotic strictures via magnetic resonance enterography and reported no surgeries among the 37 patients who completed the 48-week portion. Researchers recorded five serious adverse events across four patients during the treatment period.
Timeline
October 1, 2026: Agomab released STENOVA study results and held a webcast.
Week 24: Magnetic resonance enterography assessment was performed.
Week 48: Clinical remission and final radiological assessments were conducted.
Up to 60 weeks: Total duration of ontunisertib treatment observed.
Coming months: Agomab plans to initiate the global NOV-ERA Phase 2b study.
The Tech Race
This development marks a significant step in the clinical validation of the ALK5 and TGF-beta inhibition pathway for treating chronic gastrointestinal fibrosis. Agomab is positioning this therapeutic approach as a potential alternative to surgical interventions for patients with stricturing disease.
For patients suffering from fibrostenosing Crohn's disease, this study suggests a future, non-surgical treatment path that could replace or delay the need for invasive procedures. The planned NOV-ERA study will provide further clarity on dosing, with a higher 400 mg arm expected to be tested for greater efficacy.
The takeaway
The STENOVA results demonstrate the potential for pharmacologic inhibition of fibrosis to manage complex Crohn's disease symptoms. Patients and clinicians should look for future announcements regarding the upcoming global NOV-ERA Phase 2b trial.
Further reading
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