Cure8 news brief
Patients with fibrostenosing Crohn’s disease face progressive strictures and limited targeted treatments; data from STENOVA’s OLE and the planned NOV‑ERA trial could advance therapies that target both inflammation and fibrosis.
Updates presented at UEG Week provide early clinical evidence and signal continued development of ontunisertib for this indication.
Adults with fibrostenosing Crohn’s disease, patients with ileal strictures, clinicians treating IBD (gastroenterologists, IBD specialists), and researchers interested in anti‑fibrotic or anti‑inflammatory drug development.
Agomab will present open-label extension (OLE) data from the Phase 2a STENOVA study of ontunisertib in fibrostenosing Crohn’s disease (FSCD) at UEG Week 2026 and will host a symposium on fibro‑inflammation in IBD.
The OLE evaluated up to 60 weeks of ontunisertib 200 mg BID in patients with symptomatic ileal strictures and focused on long-term safety, pharmacokinetics, and disease progression; results are being used to support initiation of the planned global Phase 2b NOV-ERA trial.
The company describes STENOVA Part A as a randomized, placebo‑controlled 12‑week study (103 participants) with exploratory endoscopic and imaging endpoints and an OLE (Part B) in which 49 patients rolled over and 37 completed 48 weeks.
NOV‑ERA is planned as a randomized, double‑blind, placebo‑controlled Phase 2b dose‑ranging trial (up to ~320 adults) with a 52‑week treatment period; the primary endpoint will be endoscopic passability of the ileal stricture at Week 24.
This is a company press release reporting trial presentations and a planned larger trial; ontunisertib is investigational and not approved. The symposium will discuss the role of fibro‑inflammation and potential approaches addressing both inflammation and fibrosis in IBD.
This article is a company press release. Ontunisertib is investigational and not approved by regulators; the OLE data are being presented at a conference but full peer‑reviewed publication or independent validation is not provided here. NOV‑ERA is described as planned; enrollment and results are not yet available.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
This report describes open‑label extension data for ontunisertib, an investigational oral drug being tested specifically for fibrostenosing Crohn’s disease.
If you have fibrostenosing Crohn’s disease, this investigational oral drug is being studied specifically for strictures — the company reports high CDAI remission in the extension and plans a larger randomized study...
Patients with fibrostenosing Crohn’s disease have limited treatment options for the fibrotic strictures that can lead to procedures and surgery. These OLE findings suggest ontunisertib may be safe long-term and could...
