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Clinical research

Crohn’s disease investigational drug shows promise, phase II trial shows

Results from a phase 2 trial involving mongersen (GED-0301), an oral SMAD7 antisense oligonucleotide shows promise against Crohn's disease. In the image, an x-ray of a patient with Crohn's disease

Source: Phanie / Alamy

Results from a phase II trial involving mongersen (GED-0301), an oral SMAD7 antisense oligonucleotide, shows promise against Crohn’s disease (pictured in X-ray)

Crohn’s disease is associated with high levels of SMAD7, a molecule that inhibits TGF-β1 signalling, and therefore SMAD7 has been evaluated as a potential therapeutic target. Results from a phase II trial involving mongersen (GED-0301), an oral SMAD7 antisense oligonucleotide, published in The New England Journal of Medicine[1] (2015;372(12):1104–1113), are promising.

A total of 166 patients with active Crohn’s disease were randomly assigned to take mongersen (GED-0301) or placebo once daily for two weeks. At day 15, 55–65% of patients given mongersen had achieved clinical remission versus 10% in the placebo group. Most adverse events were disease-related rather than treatment-related, according to the researchers.

Mongersen, which is being developed by Celgene, will now be evaluated in a phase III trial.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20068228

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