Positive topline results were announced from 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.
The multicenter, double-blind, placebo-controlled trial enrolled more than 1000 patients with moderate to severe ulcerative colitis who had an inadequate response to prior treatment. In the induction phase, patients were randomized 2:1 to receive either ozanimod 1mg orally once daily or placebo for 10 weeks. Patients who achieved a clinical response in the induction phase or who were part of an open-label arm were eligible to proceed into the maintenance phase, in which they were re-randomized to receive ozanimod or placebo through week 52.
Results showed that ozanimod met both primary end points achieving statistically significant clinical remission at week 10 in the induction phase and at week 52 in the maintenance phase (P <.0001). Additionally, ozanimod met key secondary end points achieving clinical response and endoscopic improvement at week 10 and 52. The safety profile of ozanimod was consistent with that seen in previous studies.
Full detailed results will be presented at a future medical meeting. Patients who completed the True North trial were eligible to enroll in an ongoing open-label extension trial to evaluate the long-term safety of ozanimod.
The Company is also evaluating ozanimod for the treatment of Crohn disease in the ongoing phase 3 YELLOWSTONE program.
Ozanimod, a sphingosine 1-phosphate receptor modulator, is marketed under the brand name Zeposia® (Bristol Myers Squibb) and 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.
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