SUMMIT (dpa-AFX) - Celgene Corp. (CELG) announced that a post-hoc subgroup analysis of a double-blind, placebo-controlled, randomized, multicenter phase II trial of GED-0301 (mongersen) in patients with active Crohn's disease was presented at Digestive Disease Week (DDW) in Washington, D.C.
The primary findings of the phase II trial, which enrolled 166 adult patients with active Crohn's disease, defined as Crohn's Disease Activity Index (CDAI) scores >220 to ?400, were published in the March 19, 2015 issue of The New England Journal of Medicine.
Patients in the trial were treated for two weeks with either placebo or one of three doses of GED-0301 (10 mg, 40 mg or 160 mg tablets, once daily) and then followed for an additional 10 weeks. The presentation at DDW retrospectively examined certain subgroups of patients in the trial.
The company noted that Patients with more severe Crohn's disease or longer disease duration treated with GED-0301 160 mg experienced clinical remission and response rates greater than placebo
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