Positive Treatment Results Seen in Patients with Active Crohn’s Disease at Week 12 of Study

Positive Treatment Results Seen in Patients with Active Crohn’s Disease at Week 12 of Study
Celgene Corporation has reported positive interim results from a Phase 1b clinical trial assessing the effects of oral GED-0301 (mongersen) on endoscopic and clinical outcomes in patients with active Crohn’s disease. The trial aims to provide further data of GED-0301 activity in a difficult-to-treat, moderate-to-severe and very diverse patient population, including patients with endoscopically confirmed mucosal damage at entry, those who had previous surgeries, those who have taken biologics or are biologic naïve,  and patients with a diagnosis of ileitis, ileocolitis or colitis. Titled "A Randomized, Double-blind, Study to Explore the Effect of GED-0301 in Subjects With Active Crohn's Disease" (NCT02367183), it is evaluating GED-0301 in 63 patients assigned to one of three different treatment regimens: 160 mg GED-0301 once daily for 12 weeks; 160 mg once daily for eight weeks, then  four weeks of placebo; and 160 mg once daily for four weeks, followed by eight weeks on placebo. Topline interim data at week 12 found that  a proportion of treated patients showed endoscopic improvements (defined as 25 percent improvement from baseline). Clinical response and remission was also seen across all treatment groups, with a tolerability consistent with previous studies, and no new safety signals. “Given the high unmet need in Crohn’s disease, we are pleased that oral GED-0301 showed both endoscopic improvements and clinically meaningful responses and remission at an early timepoint in this st
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