• Brian G Feagan, Bruce E Sands, Guillermo Rossiter, Xiaobin Li, Keith Usiskin, Xiaojiang Zhan, and Jean-Frédéric Colombel.
• Robarts Clinical Trials and Western University, London, Ontario, Canada. Electronic address: brian.feagan@robartsinc.com.
• Gastroenterology. 2018 Jan 1; 154 (1): 61-64.e6.

AbstractGED-0301 is an antisense oligodeoxynucleotide with a sequence complementary to the Smad7 mRNA transcript. Smad7 is a negative regulator of transforming growth factor-β, which is increased in the intestinal mucosa of patients with active Crohn's disease (CD). We randomly assigned 63 CD patients to 4-, 8-, or 12-week treatment groups receiving oral GED-0301 (160 mg/day). The primary objective was to determine GED-0301's effect on endoscopic CD measures; secondary objectives included effects on clinical activity. Endoscopic improvement was observed in 37% of participants with evaluable endoscopy results at week 12. At week 12, 32% (4 weeks), 35% (8 weeks), and 48% (12 weeks) of patients receiving GED-0301 were in remission (CD activity index score <150); corresponding reductions from baseline in mean CD activity index scores were -124, -112, and -133 points. No new safety signals were observed. These findings support a GED-0301 benefit in active CD. ClinicalTrials.gov no: NCT02367183.Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.

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