Bristol Myers Squibb’s oral S1P receptor modulator Zeposia hit both primary endpoints in a phase III trial as an induction and maintenance therapy in adult patients with moderate-to-severe ulcerative colitis (UC).
The True North study showed that Zeposia (ozanimod) demonstrated statistically significant and clinically meaningful results for clinical remission compared to placebo at induction at week ten (18.4% versus 6.0%) and in maintenance at week 52 (37.0% versus 18.5%).
Zeposia also met key secondary endpoints, including clinical response, endoscopic improvement and mucosal healing in induction at week ten and in maintenance at week 52.
In addition, significantly more patients treated with Zeposia compared to placebo achieved clinical response at week ten (47.8% versus 25.9%) and at week 52 (60.0% versus 41.0%), with consistent results across sub-analyses.
In patients with prior TNF-inhibitor exposure, clinical remission results favoured Zeposia over placebo, although the findings were not significant at week ten. A nominally statistically significant difference was observed for clinical response, however.
“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,” said Mary Beth Harler, head of Immunology and Fibrosis Development, BMS.
“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,” she added.
Zeposia was approved earlier this year for the treatment of adults with relapsing forms of MS, including relapsing-remitting MS (RRMS), active secondary progressive MS (SPMS) and clinically isolated syndrome (CIS).