Chugai Presents Results from Second Positive Global Phase III Clinical Study of Satralizumab in NMOSD at ECTRIMS 2019
TOKYO--(BUSINESS WIRE)--Sep 12, 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
[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)
Satralizumab, created by Chugai, is an anti-IL-6 receptor humanized recycling antibody. The drug is expected to suppress relapse of NMOSD by inhibiting IL-6 signal transduction which is deeply related to the pathology. In two global phase III clinical studies in NMOSD patients, the primary endpoint was achieved with satralizumab either as an add-on therapy to baseline treatment (NCT02028884) or as monotherapy (NCT02073279). These studies represent one of the largest clinical trial programs undertaken for this rare diseases. Satralizumab is designated as an orphan drug in the U.S. and Europe. In addition, it has been granted Breakthrough Therapy Designation for the treatment of NMO and NMOSD by the U.S. Food and Drug Administration in December 2018.
About neuromyelitis optica spectrum disorder (NMOSD)
NMOSD is a rare, lifelong, and debilitating autoimmune disease of the central nervous system (CNS) characterized by inflammatory lesions in the optic nerves and spinal cord. Patients with NMOSD frequently experience a relapsing disease course with repeated attacks leading to accumulating neurological damage and disability. Symptoms may include visual impairment, motor disability, and loss of quality of life. In some cases, attacks of NMOSD result in death. NMOSD is commonly associated with pathogenic antibodies (AQP4-IgG) that target and damage a specific central nervous cell type, called astrocytes resulting in inflammatory lesions of the optic nerve(s), spinal cord and brain. AQP4-IgG are detectable in the blood serum of around two-thirds of NMOSD patients. The inflammatory cytokine IL-6 is now emerging as an important factor in NMOSD pathogenesis 1)-4).
Diagnostic criteria introduced in 2006 for NMO were characterized by inflammation of the optic nerve (optic neuritis) and the spinal cord (myelitis). These were revised in 2007 with the definition of NMOSD, proposed for diseases with either optic neuritis or myelitis. In 2015, the definition of NMOSD was further revised to include a broader spectrum of disease. The diagnostic term NMOSD is now widely used 5).
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PUB: 09/12/2019 01:03 AM/DISC: 09/12/2019 01:03 AM