Agomab reports positive OLE data for ontunisertib in Crohn's bowel strictures

Agomab Therapeutics NV announced on October 1, 2026 positive topline results from the open-label extension (OLE) portion of its Phase 2a STENOVA trial testing ontunisertib in patients with fibrostenosing Crohn's disease (FSCD).

The OLE study, known as Part B, tested long-term treatment with ontunisertib 200 mg twice daily on top of standard of care, and 94% of patients eligible from the 12-week placebo-controlled Part A chose to enroll, totaling 49 participants.¹ Agomab said the data showed a generally favorable long-term safety and tolerability profile at the 200 mg twice-daily dose for up to 60 weeks, along with continued low systemic drug exposure consistent with earlier findings.¹

Safety data showed five serious adverse events across four patients during the 48-week extension, with the company stating all were judged unrelated or unlikely related to treatment.¹ No signs of cardiac injury, pro-inflammatory effects, vasculitis, liver toxicity, or blood clotting events were observed during extended treatment.¹

On efficacy measures, the annualized rate of FSCD-related events was 3% among patients on 200 mg twice daily for up to 60 weeks.¹ Only one such event, a balloon dilation procedure, occurred during the study, and no patients required surgery.¹ By week 48, 97% of evaluable patients were in clinical remission based on CDAI scoring.¹

Looking ahead, Agomab said it has finished regulatory submissions for NOV-ERA, a global Phase 2b study planned to enroll about 320 symptomatic FSCD patients across three ontunisertib dose arms (400 mg, 200 mg, and 100 mg twice daily) versus placebo, with initiation targeted in the coming months.¹ The trial's primary endpoint will be the proportion of patients achieving endoscopic passability of the ileal index stricture at Week 24.¹