Positive results from Phase III SAkuraSky study for Chugai's satralizumab

Positive news results of the SAkuraSky Study, a global Phase III clinical study of satralizumab (development code: SA237) have published in the online version of The New England Journal of Medicine (NEJM), Japanese drugmaker Chugai Pharmaceutical (TYO: 4519), which is majority-owned by Roche (ROG: SIX), announced today.

Satralizumab, for which Chugai filed with the Japanese Ministry of Health, Labor and Welfare (MHLW) earlier this month, is an anti-IL6 receptor humanized recycling antibody under development for the treatment of neuromyelitis optica spectrum disorder (NMOSD). The Phase III study examined the efficacy and safety of satralizumab added to baseline therapy in patients with NMOSD.

“Relapses of NMOSD may lead to accumulation of disabilities and can be life-threatening. These data further reinforce the importance of interleukin (IL)-6 signal inhibition in treating NMOSD,” said Dr Yasushi Ito, Chugai’s executive vice president, co-head of Project & Lifecycle Management Unit, adding: “The SAkuraSky study is the first clinical study to demonstrate the efficacy and safety of an investigational medicine for NMOSD regardless of AQP4-IgG expression.”

In SAkuraSky Study, only eight of 41 patients (20%) treated with satralizumab in combination with baseline immunosuppressant therapy experienced a protocol-defined relapse (PDR) compared to 18 of 42 patients (43%) treated with placebo in combination with baseline therapy (HR=0.38, 95% CI: 0.16-0.88; p=0.02 [stratified log-rank test]) in the overall population, representative of NMOSD patients (including anti-AQP4-IgG antibody seropositive and seronegative patients).