Agomab reports Crohn’s trial extension data

• Agomab (NASDAQ:AGMB) reported topline results from the STENOVA open-label extension evaluating ontunisertib in fibrostenosing Crohn’s disease.
• The 48-week extension included 49 patients, with a 3% annualized disease-related event rate and no surgeries reported.
• Agomab completed regulatory filings for the NOV-ERA Phase 2b trial and plans to begin the approximately 320-patient study.

Agomab (NASDAQ:AGMB) reported topline results from the STENOVA open-label extension study of ontunisertib in patients with fibrostenosing Crohn’s disease, with 49 patients completing the 48-week extension period.

The extension evaluated ontunisertib at 200 mg twice daily alongside standard care, with Agomab reporting generally favorable safety and tolerability through up to 60 weeks of treatment.

Five serious adverse events occurred in four patients and were considered unrelated or unlikely related to treatment, while the annualized disease-related event rate was 3%, including one endoscopic balloon dilation and no reported surgeries.

Imaging assessments suggested stricture stabilization, and 97% of evaluable patients were in clinical remission at extension Week 48, although optional Week 48 endoscopy data were limited.

Agomab stated that regulatory filings for the NOV-ERA Phase 2b trial are complete and that the approximately 320-patient study is expected to begin in the coming months.