The study will enroll 320 adults, comparing the efficacy of ontunisertib against a placebo. Clinical success will be measured at 24 weeks by the ability of a scope to pass through previously narrowed sections of the intestine, providing a clear visual indicator of reduced blockage. Researchers plan to monitor participants for a full 52 weeks to evaluate long-term durability and safety.
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Agomab Clears Regulatory Path for Crohn’s Stricture Trial
Nearly half of all Crohn’s disease patients eventually develop fibrotic intestinal narrowings, yet no approved medical treatment exists to resolve these blockages. Agomab Therapeutics has now secured FDA alignment on a Phase 2b trial design to test whether its experimental pill, ontunisertib, can successfully widen these obstructive intestinal segments.
Agomab has already received clearance from a central ethics board in the U.S. and secured approval from Health Canada. With regulatory applications pending across Europe and Asia, the company expects to administer the first dose to a patient in the second half of this year. This trial represents a high-stakes effort to offer a non-surgical alternative for patients currently facing the high probability of invasive intestinal procedures.
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