Agomab Therapeutics (AGMB) Study result summary

Study design and patient population

• STENOVA was a Phase 2a trial in fibrostenosing Crohn’s disease (FSCD); its 48-week open-label extension (OLE) evaluated ontunisertib 200 mg twice daily for up to 60 weeks.

• 49 patients entered the OLE, representing 94% of eligible participants; 37 completed and 12 discontinued, a ~25% dropout rate.

• Participants had long-standing disease, averaging 15–17 years; ~40% had prior stricture resection and 75% received stable-dose anti-inflammatory biologics.

Safety and pharmacokinetics

• Five serious adverse events occurred in four patients; all were considered unrelated or unlikely related to treatment, and no discontinuations were due to adverse events.

• No new safety signals were detected, including cardiac injury, pro-inflammatory effects, vasculitis, liver toxicity, thrombotic events, or ECG concerns.

• Low systemic exposure and gut-restricted pharmacokinetics were maintained through extended treatment, with plasma concentrations below IC50 levels.

Efficacy and disease control

• At week 48, 97% of evaluable patients were in clinical remission; symptom control and quality-of-life scores improved or remained favorable during the OLE.

• MRI assessments suggested stabilization and possible improvement of strictures, with more consistent patterns in patients with longer baseline strictures.

• One endoscopic balloon dilation and no surgeries were reported, corresponding to a 3% annualized FSCD-related event rate; retrospective reference studies reported 23–35%, though cross-study comparisons warrant caution.