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In a phase II study, mongersen (GED-0301) was found effective for achieving clinical remission in patients with active Crohn disease. This molecule has a novel mechanism of action, providing local anti-inflammatory effect by downregulation of the cytokine Smad7, and it is formulated for delayed release in the distal small intestine. Now, investigators report findings of an industry-funded, multicenter, phase III study of this non–FDA-approved agent.
In this 52-week trial, 701 patients with active Crohn disease were randomized to receive one of three different dosage regimens of once-daily mongersen or once-daily placebo. The primary endpoint was clinical remission at week 12. Enrollment was stopped prematurely because of perceived lack of be…