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Agomab Announces Design of NOV-ERA Phase 2b Study with Ontunisertib in Fibrostenosing Crohn’s Disease

AGMB
  • Agomab Therapeutics announced the design of the Phase 2b NOV-ERA study for ontunisertib to treat Fibrostenosing Crohn's Disease (FSCD).
  • The study design aligns with FDA requirements, featuring a novel primary endpoint of endoscopic passability at Week 24.
  • First participants in the NOV-ERA trial are expected to be dosed in the second half of 2026.
  • The trial is a randomized, double-blind, placebo-controlled, dose-ranging study enrolling up to 320 adults with non-passable ileal strictures.
  • Participants will be randomized 1:1:1:1 to receive one of three ontunisertib doses (400 mg, 200 mg, 100 mg) or a placebo twice daily.
  • The study protocol has cleared U.S. IRB approval, received Health Canada approval, and Clinical Trial Applications are pending in the EU 2026-06-23-Asia Pacific regions.
  • Ontunisertib is an oral, GI-restricted ALK5 inhibitor with U.S. FDA Fast Track Designation.
  • Approximately 46% of Crohn's disease patients suffer from FSCD, a condition with no currently approved pharmacological therapies.
  • The trial includes a 6-week screening period, a 52-week treatment period, 2026-06-23-2-week follow-up.
  • Secondary endpoints include endoscopic passability at Week 52, MRE imaging changes, SES-CD score changes, patient-reported outcomes, 2026-06-23-time to FSCD-related events.