The phase 3 True North trial evaluating the efficacy of ozanimod as an induction and maintenance therapy for adults with moderate to severe ulcerative colitis met both primary and key secondary end points, according to Bristol Myers Squibb.

Ozanimod is a sphingosine 1-phosphate receptor modulator marketed under the brand name Zeposia®. The product is currently approved for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. 

The multicenter, double-blind, placebo-controlled True North study included patients with moderate to severe ulcerative colitis who had an inadequate response to prior treatment. In the induction phase, patients were randomized to receive either ozanimod 1mg orally once daily (n=429) or placebo (n=216) for 10 weeks. Patients who achieved a clinical response in the induction phase or who were part of an open-label arm (n=367) were eligible to proceed into the maintenance phase, in which they were re-randomized to receive ozanimod (n=230) or placebo (n=227) through week 52.

Results showed that ozanimod met both primary end points achieving statistically significant clinical remission at week 10 in the induction phase (18.4% vs 6% for placebo; P <.0001) and at week 52 in the maintenance phase (37% vs 18.5% for placebo; P <.0001).

Additionally, ozanimod met key secondary end points achieving clinical response, endoscopic improvement, and mucosal healing at week 10 (47.8% vs 25.9% for placebo; P <.0001) and at week 52 (60% vs 41% for placebo; P <.0001); results were found to be consistent across subgroups. The safety profile of ozanimod was found to be similar to that seen in previous studies.

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“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, MD, 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.”

Additional data will be presented at UEG Week Virtual 2020.

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Bristol Myers Squibb presents positive late-breaking data from phase 3 True North trial evaluating Zeposia (ozanimod) in adult patients with moderate to severe ulcerative colitis. [press release]. Princeton, NJ: Bristol Myers Squibb; October 10, 2020.