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Chugai Presents Results from Second Positive Global Phase III Clinical Study of Satralizumab in NMOSD at ECTRIMS 2019

Roche tablets are seen in this photo illustration shot in Zenica, Bosnia and Herzegovina, January 18, 2016. REUTERS/Dado Ruvic/File Photo

TOKYO–(BUSINESS WIRE)–#NMOSDChugai 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)

Summary:

A phase III multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of satralizumab administered to patients with NMOSD

[Primary Endpoint]

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

Study design:

Main results:

[Reference for SAkuraSky study]

Chugai Presents Results from Phase III Study of Satralizumab in NMOSD at ECTRIMS 2018 (Press release issued on October 15, 2018)

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