Celgene Presents Data on Crohn’s Therapy at DDW

Celgene Presents Data on Crohn’s Therapy at DDW
Celgene Corporation recently presented data regarding studies of its investigational oral antisense therapy called GED-0301 (mongersen) for the treatment of active Crohn's disease at the Digestive Disease Week (DDW), which took place in Washington, D.C. The company conducted a double-blind, placebo-controlled, randomized, multicenter phase II trial and presented its post-hoc subgroup analysis. The clinical trial was designed to evaluate the therapy, which is an oligonucleotide expected to target the messenger RNA (mRNA) for Smad7 and, consequently, decrease the levels of Smad7 protein, in 166 adults who suffer from moderate-to-severe Crohn’s disease, as well as inflammatory lesions in the terminal ileum and/or right colon. The high levels of Smad7 cause abnormal function of the TGF-β1 anti-inflammatory pathways in the gut, worsening inflammation. “For patients with Crohn’s, disease severity and duration can influence the therapeutic effect of certain medicines,” explained in a press release professor Giovanni Monteleone from the University of Rome Tor Vergata. “This subgroup analysis of data from the phase II study explored the effects of these factors on clinical response and clinical remission rates with GED-0301 — being investigated as an orally administered antisense therapy with a novel mechanism of action designed to act locally.” Celgene researchers focused on the Crohn’s Disease Activity Index (CDAI) scores >220 to ≤400 as primary findings of the phase II study, results that were published last March in The New England Journal of Medicine. Crohn's disease patients received treatment with placebo or three doses of GED-0301 for two weeks, and were followed during 10 weeks after that. At the DDW, the investigators pre
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