Bristol Myers Squibb (BMS) said that the phase 3 True North clinical trial evaluating Zeposia (ozanimod) in adult patients with moderate to severe ulcerative colitis (UC) met both primary endpoints.
The placebo-controlled late stage trial featuring 645 patients assessed oral Zeposia as an induction and maintenance therapy for the chronic inflammatory bowel disease (IBD).
ZEPOSIA is approved by the US Food and Drug Administration in March 2020 for the treatment of relapsing forms of multiple sclerosis (MS).
According to Bristol Myers Squibb, the True North clinical trial showed highly statistically significant and clinically meaningful results for clinical remission for the sphingosine-1-phosphate (S1P) receptor modulator compared to placebo. This was at induction at Week 10, 18.4% versus 6.0%, and in maintenance at Week 52, 37.0% vs 18.5%.
The True North study also met key secondary endpoints. These included clinical response, endoscopic improvement, and mucosal healing in induction at Week 10 and also in maintenance at Week 52.
Bristol Myers Squibb said that significantly more patients subjected to its S1P receptor modulator compared to placebo achieved clinical response at Week 10, 47.8% vs 25.9%, and at Week 52, 60.0% vs 41.0% with consistent results across sub-analyses.
William Sandborn – 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, said: “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.
“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.”
The overall safety noted during the North clinical trial was in line with the known safety profile for Zeposia and patients having moderate to severe ulcerative colitis.
Mary Beth Harler – Bristol Myers Squibb Immunology and Fibrosis Development head said: “These Zeposia True North results represent a meaningful achievement for patients living with ulcerative colitis, many of whom have an inadequate response or do not respond at all to currently available therapies.
“We look forward to working with health authorities to bring Zeposia to this patient population and remain committed to pursuing new scientific advances to help deliver transformational medicines for the gastroenterology community.”
In May 2020, Zeposia was also approved by the European Commission for relapsing remitting multiple sclerosis (RRMS) in adult patients having active disease as defined by clinical or imaging features.