Cure8 news brief
This trial focuses on fibrostenosing Crohn’s disease, a form of IBD where strictures can block the intestine; a successful drug could offer a medical option to improve endoscopic passability and reduce need for procedures.
Dose-ranging Phase 2b results will help determine whether ontunisertib is effective and safe enough to move to later-stage testing.
Adults with fibrostenosing Crohn’s disease or intestinal strictures, patients interested in emerging non‑surgical treatments for strictures, gastroenterologists, IBD researchers, and clinical trialists.
AgomAb announced initiation of NOV-ERA, a global randomized, double-blind, placebo-controlled Phase 2b trial testing ontunisertib in symptomatic fibrostenosing Crohn’s disease (FSCD).
The study plans ~320 adults randomized 1:1:1:1 to ontunisertib 400 mg, 200 mg, 100 mg twice daily, or placebo, with a 52‑week treatment period and a primary endpoint of endoscopic passability of the ileal index stricture at Week 24. Study start triggered a €7 million milestone payment tied to AgomAb’s 2021 acquisition of Origo Biopharma.
Ontunisertib is investigational and not approved by regulators.
The source is an SEC Form 6‑K / company filing excerpt reported by a financial site; details reflect the company’s trial design and milestone payment facts. Ontunisertib remains investigational; this announcement reports trial initiation and planned design rather than clinical results.
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.
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 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...
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...
