Ontunisertib Trial Showed Positive Remission Results
The investigational treatment demonstrated clinical remission in most patients with fibrostenosing Crohn's disease over 48 weeks.
Updated on Oct. 1, 2026 in Biotech
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Agomab Therapeutics has reported topline data from its Phase 2a open-label extension study of ontunisertib, an investigational treatment for fibrostenosing Crohn's disease. Among the 49 participants, 97% achieved clinical remission by Week 48 based on the Crohn's disease activity score.
Why it matters
The development marks a potential move toward pharmacological management of fibrotic strictures in Crohn's disease, which typically require invasive interventions. These results support the expansion of the treatment into a larger global Phase 2b study.
Patients received 200 mg of ontunisertib twice daily, resulting in an annualized fibrostenosing Crohn's disease-related event rate of 3%. The study observed radiological stabilization of fibrotic strictures via magnetic resonance enterography.
The players
Agomab Therapeutics
A biotech firm based in Antwerp, Belgium, focused on developing therapies for fibrotic diseases by modulating regenerative signaling pathways.
The details
Ontunisertib is a small-molecule inhibitor designed to target ALK5 (activin receptor-like kinase 5) and TGF-beta (transforming growth factor-beta), signaling proteins that drive the scarring process known as fibrosis. By inhibiting these pathways in the gastrointestinal tract, the drug aims to stop the accumulation of extracellular matrix proteins that cause bowel strictures. The open-label extension allowed 49 participants to continue treatment for up to 60 weeks in addition to their standard of care.
Timeline
October 1, 2026: Agomab announced the study results.
Week 24: Magnetic resonance enterography assessment was performed.
Week 48: Clinical remission and final radiological assessments occurred.
Up to 60 weeks: Total duration of ontunisertib treatment observed.
Coming months: Scheduled initiation of the global NOV-ERA Phase 2b study.
The Tech Race
This development follows a push to replace surgical dilation for fibrotic Crohn's strictures with targeted medical therapies. The successful Phase 2a data sets the stage for the NOV-ERA study, which aims to scale the treatment to 320 global patients.
The study indicates a shift toward potentially avoiding endoscopic balloon dilation or surgical intervention for patients with fibrotic strictures. Availability remains limited to those participating in clinical trials until the global Phase 2b study concludes and results are submitted to regulators.
The takeaway
The study suggests that targeting ALK5 and TGF-beta may stabilize fibrotic bowel tissue without surgery. Watch for the initiation of the global NOV-ERA Phase 2b trial, which plans to test a higher 400 mg dosage to further optimize clinical outcomes.
Further reading
For broader trends in gastrointestinal therapeutic development, see Biotech.
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Should regulatory agencies fast-track clinical testing for potential new treatments for chronic diseases?
