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BMS presents at UEG week, positive late-breaking data from phase III True North Trial evaluating Zeposia in adult patients with moderate to severe ulcerative colitis

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Published:12th Oct 2020
Bristol Myers Squibb announced detailed results from True North, a pivotal, placebo-controlled Phase III trial evaluating oral Zeposia (ozanimod) as an induction and maintenance therapy for patients with moderate to severe ulcerative colitis. (UC). True North met both primary endpoints, demonstrating highly statistically significant and clinically meaningful results for clinical remission compared to placebo at induction at Week 10 (18.4% versus 6.0%; p-value<0.0001) and in maintenance at week 52 (37.0% vs 18.5%; p><0.0001).the study also met key secondary endpoints, including clinical response, endoscopic improvement and mucosal healing in induction at week 10 and in maintenance at week 52. significantly more patients treated with zeposia compared to placebo achieved clinical response at week 10 (47.8% vs 25.9%; p><0.0001) and at week 52 (60.0% vs 41.0%; p><0.0001) with consistent results across sub-analyses. the overall safety observed was consistent with the known safety profile for zeposia and patients with moderate to severe uc. efficacy and safety results from the 10-week induction period (abstract lb02, ueg research prize 2020 session) and from the maintenance period at week 52 (abstract lb10) from true north will be presented on october 11 at 12:32 cest and at 15:24 cest, respectively, in two late-breaking oral presentations at ueg week virtual 2020.>
Condition: Ulcerative Colitis
Type: drug

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