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Cure8 news brief
Why This Matters
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 slow stricture progression, which could reduce the need for interventions if confirmed in later trials.
Who Should Pay Attention
Adults with fibrostenosing Crohn’s disease, clinicians caring for patients with stricturing Crohn’s disease, IBD researchers, and people interested in anti‑fibrotic or gut‑targeted therapies.
Study Snapshot
Story typeCompany update
Evidence typePhase 2 clinical trial
Source depthFull source text
What To Know
Agomab announced positive results from the 48-week open-label extension (OLE) of the Phase 2a STENOVA trial testing ontunisertib 200 mg twice daily in fibrostenosing Crohn’s disease (FSCD).
The company reports favorable long-term safety and tolerability through up to 60 weeks, low systemic exposure consistent with a gut‑restricted PK profile, radiological trends toward stricture stabilization on MRE, sustained symptom control, and a low annualized FSCD‑related event rate (one endoscopic balloon dilation and no surgeries reported).
The press release states these OLE results support starting a global Phase 2b NOV-ERA study.
Keep In Mind
This is a company press release reporting OLE data from a Phase 2a study; results are preliminary and come from an open‑label extension rather than a randomized controlled trial. Optional endoscopy data were limited and the release compares event rates to external publications rather than head‑to‑head controls.
Further results from the planned Phase 2b (NOV‑ERA) study will be needed to confirm efficacy and safety.
Source Details
Review the original publication for the complete reporting, methods, and context.
Phase 2 clinical trial
Article type assigned from Cure8 classification; confirm details in the original source.
Publicationmarkets.businessinsider.com
Authorsmarkets.businessinsider.com
Indexed viaBing News
Source typeWeb article
PublishedOct 1, 2026, 1:31 AM
Content availableFull source text
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.
NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's Disease
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