Agomab, FDA Agree on Phase 2b Trial for Crohn's Disease Treatment
By Doc Louallen
Agomab Therapeutics reached alignment with the Food and Drug Administration on the design of a Phase 2b study for patients with Crohn's disease who develop intestinal narrowings that can block food and often lead to surgery.
The study will test Agomab's experimental pill, ontunisertib, against placebo in up to 320 adults, the Belgium-based company said Tuesday. Doctors will check at 24 weeks whether a scope can pass through the narrowed section of the intestine, which is a practical way to see if the blockage is easing. The trial will also follow patients to 52 weeks to track longer-term outcomes.
Agomab said the protocol has been filed with the FDA and cleared a central ethics review in the U.S., and the study has Health Canada approval. The company has also submitted clinical trial applications in Europe and parts of Asia. The first patient is expected to be dosed in the second half of this year.
Crohn's is a chronic progressive disease of the gastrointestinal tract. About 46% of all patients develop fibrotic narrowings over time, and there are no approved drugs for treatment of the condition.
Write to Doc Louallen at Doc.Louallen@wsj.com
(END) Dow Jones Newswires
June 23, 2026 17:29 ET (21:29 GMT)
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