Bristol Myers Squibb Presents Interim Results from Long-Term Study Reinforcing Maintenance of Response and Safety Profile of Zeposia (ozanimod) in Patients with Moderately to Severely Active Ulcerative Colitis

The percentage of patients achieving clinical remission, clinical response, endoscopic improvement and corticosteroid-free remission was maintained through Week 142

Zeposia is the first and only oral sphingosine 1-phosphate (S1P) receptor modulator approved to treat patients with ulcerative colitis

Excerpt from the Press Release:

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced interim results from the True North open-label extension study evaluating the long-term efficacy and safety profile of Zeposia (ozanimod) in patients with moderately to severely active ulcerative colitis (UC). Findings show that the percentage of patients achieving clinical remission, clinical response, endoscopic improvement and corticosteroid-free remission was maintained through Week 142. No new safety signals emerged in the study. These data (Presentation #DOP44) will be presented at the 17^th Congress of the European Crohn’s and Colitis Organisation (ECCO), taking place February 16-19, 2022.

“For clinicians treating patients with this serious, chronic disease, results from the True North extension study provide an understanding of long-term therapeutic outcomes and help to identify an appropriate treatment approach for their patients with ulcerative colitis,” said Silvio Danese, M.D., Director, Gastroenterology and Endoscopy, IRCCS, San Raffaele Hospital and University Vita-Salute San Raffaele in Milan. “These findings demonstrate important and clinically meaningful responses across multiple key endpoints and build upon our current knowledge of the efficacy and safety profile of Zeposia.”

In the True North extension study, data from an interim analysis of patients (n=823) who had previously participated in the Phase 3 True North Zeposia clinical trial were examined. At Weeks 46, 94 and 142, 45% (203/452), 51% (109/213) and 45% (39/87) of participants, respectively, were in clinical remission, and 80% (352/441), 84% (176/209) and 86% (73/85) achieved clinical response, respectively. The efficacy of Zeposia in those who entered the long-term study as responders on Day 1 was higher compared to the total population, with 70% (107/152) and 69% (42/61) achieving clinical remission at Weeks 46 and 94, respectively, and 95% (145/152) and 98% (60/61) achieving clinical response at Weeks 46 and 94, respectively. At the time of this analysis, of the 823 patients from the Phase 3 True North trial who entered the open-label extension study, 64% subsequently completed Week 46, 34% completed Week 94, and 14% completed Week 142. The most common reason for discontinuation was lack of efficacy (21%). No new safety signals were seen with longer-term Zeposia use in the 1,158 patients within the pooled population, including patients from the Phase 2 Touchstone study and the Phase 3 True North study.

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