Satralizumab Overview

Introduction of Satralizumab

Satralizumab (SA237), a humanized IgG2 targeting interleukin-6 (IL-6) receptor (IL-6R), is undergoing evaluation in two Phase 3 studies of patients with neuromyelitis optica (NMO) or NMO spectrum disorder. The constant and variable regions of the mAb were engineered for half-life extension. Enrollment is ongoing in the placebo-controlled Phase 3 NCT02028884 study, which is evaluating the efficacy and safety of SA237 added to baseline treatment in patients with NMO and NMO spectrum disorder. The primary outcome measure is the time to first relapse up to ~ 30 months from the entry of the first patient into the study. The estimated enrollment is 70 and the estimated primary completion date is July 2018. Enrollment is complete in the placebo-controlled Phase 3 NCT02073279 study, which is evaluating the efficacy and safety of SA237 as monotherapy in patients with NMO and NMO spectrum disorder. The primary outcome measure is the time to first relapse up to ~ 38 months from the entry of the first patient into the study. A total of 95 patients are enrolled, and the estimated primary completion date is October 2018. Satralizumab was granted the United States and the European Union orphan designations for the treatment of NMO spectrum disorders. According to the Roche pipeline listing, an application submission for satralizumab is anticipated in 2018.

Mechanism of Action of Satralizumab

NMO is an inflammatory disorder of the central nervous system that predominantly affects the optic nerves and spinal cord. NMO is characterized by anti-aquaporin 4 (AQP4) antibody-mediated astrocytopathy. Cerebrospinal fluid (CSF) cytokine analyses have shown the significant upregulation of Th2-related cytokines and Th17‐related cytokines, such as IL-6, IL-8 and the granulocyte colony-stimulating factor (G-CSF), in the active phase of NMO patients. Among these significantly elevated cytokines, IL-6 presumably plays an important role in the immunopathogenesis of NMO, because it is involved in the production of anti-AQP4 antibody in the peripheral circulation and in the enhancement of inflammation in the central nervous system, the level of IL-6 in CSF can be a biomarker of the prognosis and disease activity of NMO. Satralizumab targets the IL-6 receptor, thereby inhibiting the IL-6-involved pathways which participate in the pathogenesis of NMO.

Fig.1 Mechanism of action of satralizumab

What We Provide

Therapeutic Antibody

Satralizumab

We provide high-quality Satralizumab for use in WB, FC, IP, ELISA, Neut, FuncS, IF and most other immunological methods. For lab research use only, not for diagnostic, therapeutic or any in vivo human use.

For research use only. Not intended for any clinical use.