Bristol Myers Squibb announced detailed results from True North, a pivotal, placebo-controlled Phase 3 trial evaluating oral Zeposia (ozanimod) as an induction and maintenance therapy in adult 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.
“The data from the Zeposia True North trial demonstrate patients with moderate to severe ulcerative colitis achieved clinically meaningful improvements in key clinical, endoscopic and mucosal healing endpoints,” said William Sandborn, M.D., chief, Division of Gastroenterology and director, Inflammatory Bowel Disease Center at University of California (UC), San Diego Health and professor of medicine, UC San Diego School of Medicine. “Notably, the endoscopic and histologic benefits, which can be difficult to achieve, suggest Zeposia has the potential to address the need for a safe and effective oral treatment option for this serious, chronic disease.”
About True North
True North is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of Zeposia 1mg in patients with moderate to severe ulcerative colitis who did not adequately respond to prior treatment. In the induction phase, a total of 645 patients were randomized to receive Zeposia (n=429) or placebo (n=216), of whom 94% and 89%, respectively, completed the induction period. At study entry, mean age was 42 years, 60% were male and mean disease duration was 7 years; patient characteristics were well-balanced across treatment groups. Cohort 1 patients were randomized 2:1 to Zeposia or placebo and treated once daily for 10 weeks. Cohort 2 (n=367) was an open-label arm, and included to allow adequate patient numbers for the maintenance phase of the trial. Cohort 2 patients were treated once daily with Zeposia for 10 weeks.
