12 September 2019 | News
Pivotal Phase III SAkuraStar study shows 55% reduction in the risk of relapse for satralizumab monotherapy versus placebo presented at ECTRIMS Congress 2019
Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced that the results from SAkuraStar Study were presented at the Congress of European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2019 (from September 11 to 13). SAkuraStar study is a phase III multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of an investigational anti-IL-6 receptor humanized recycling antibody satralizumab (development code: SA237) as monotherapy for the treatment of neuromyelitis optica spectrum disorder (NMOSD).
In SAkuraStar study, satralizumab significantly reduced the risk of relapse by 55% (hazard ratio=0.45 [95% confidence interval: 0.23-0.89], p=0.0184 [stratified log-rank test]) in the overall population, representative of NMOSD patients (including aquaporin-4 antibodies [AQP4-IgG] seropositive and seronegative patients). Satralizumab has shown a favorable safety profile during the study.
“Satralizumab is the first investigational medicine for the treatment of NMOSD that has demonstrated benefits both as a monotherapy and add-on therapy to baseline treatment in two separate trials, suggesting that IL-6 inhibition could be a novel therapeutic approach for NMOSD, and satralizumab may contribute to a broad range of patients,” said Dr. Yasushi Ito, Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit. “NMOSD is a disease in which relapse may lead to accumulation of disabilities, and can be life-threatening. We will collaborate with Roche to file global regulatory applications this year so that we can bring satralizumab as a potential new treatment to patients as soon as possible.”
SAkuraStar Study (NCT02073279)
A phase III multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of satralizumab administered to patients with NMOSD
Time to first protocol-defined relapse adjudicated by an independent review committee in the double-blind period
[Main Secondary Endpoints]
Visual Analogue Scale (VAS) score for pain
Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score