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    Satralizumab

    Other names: RG6168; RO5542844

    Modality: Humanized IL-6 receptor antagonist mAb

    Disease State: AIE, MOG-AD, NMOSD, TED

    Summary

    Satralizumab (RG6168) is an humanized monoclonal antibody to the interleukin-6 (IL-6) receptor.1

    Clinical Trials

    Satralizumab
    NCT ID Study Phase Enrollment Status Study Title
    NCT05199688 Phase III Recruiting A Study to Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, and Pharmacodynamics of Satralizumab in Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD) View details
    NCT05271409 Phase III Active, not recruiting A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease View details
    NCT05503264 Phase III Active, not recruiting A Study to Evaluate the Efficacy, Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Satralizumab in Participants With Anti-N-methyl-D-aspartic Acid Receptor (NMDAR) or Anti-leucine-rich Glioma-inactivated 1 (LGI1) Encephalitis View details
    NCT06450639 Phase II Active, not recruiting A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD) View details

    Proposed Mechanism of Action

    Satralizumab is an humanized, IgG2, monoclonal recycling antibody that targets the IL-6 receptor.1–4

    Satralizumab’s proposed mechanism of action involves binding to both membrane-bound and soluble forms of the IL-6 receptor, preventing IL-6 from binding and thus inhibiting the inflammatory IL-6 signaling pathways.1,5

    By inhibiting IL-6 activity, satralizumab reduces pro-inflammatory signaling processes associated with many autoimmune disorders.1,5,6

    Satralizumab was engineered to ensure sustained suppression of IL-6 signaling.1

    The antigen-binding fragment (Fab) was engineered for high-affinity binding to the mIL-6R and sIL-6R under neutral pH conditions1

    The Fab fragment was also designed to give satralizumab a low antibody molecule isoelectric point, which reduces non-specific clearance of satralizumab in the bloodstream.1

    The crystallizable fragment (Fc) structure was engineered with a modified IgG2 backbone, to allow1,3:

    1. Strong binding to FcRn under acidic pH conditions, which enables FcRn to recycle the antibody to the cell surface from inside the endosome

      1. This is known as Recycling Antibody™ technology
      2. The Recycling Antibody™ technology prolongs the plasma half-life of satralizumab and enables each antibody to bind the IL-6R multiple times

    2. Reduced binding affinity to FcγR, to minimize undesired effector activities such as antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC)

    1. Yamamura T, Kleiter I, Fujihara K, et al. Trial of Satralizumab in Neuromyelitis Optica Spectrum Disorder. N Engl J Med. 2019;381(22):2114-2124. doi:10.1056/​NEJMoa1901747
    2. Reichert JM. Antibodies to watch in 2017. MAbs. 2017;9(2):167-181. doi:10.1080/​19420862.2016.1269580.
    3. Genentech, Inc. ENSPRYNG™ (satralizumab-mwge). Prescribing Information. 2021. Accessed September 2022. https://www.accessdata.fda.gov/​drugsatfda_docs/​label/​2021/​761149s002lbl.pdf
    4. Roche Registration GmbH. ENSPRYNG™ (satralizumab-mwge). Summary of Product Characteristics. 2021. Accessed September 2022. https://www.ema.europa.eu/​en/​documents/​product-information/​enspryng-epar-product-information_en.pdf
    5. Traboulsee A, Greenberg BM, Bennett JL, et al. Safety and efficacy of satralizumab monotherapy in neuromyelitis optica spectrum disorder: a randomised, double-blind, multicentre, placebo-controlled phase 3 trial. Lancet Neurol. 2020;19(5):402-412. doi:10.1016/​S1474-4422(20)30078-8
    6. Schett G. Physiological effects of modulating the interleukin-6 axis. Rheumatology (Oxford). 2018;57(suppl_2):ii43-ii50. doi:10.1093/​rheumatology/​kex513

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    TOP

    • ADCC
      Antibody-dependent cellular cytotoxicity

    • AIE
      Autoimmune encephalitis

    • CDC
      Complement-dependent cytotoxicity

    • Fab
      Antigen-binding fragment

    • Fc
      Crystallizable fragment

    • FcRn
      neonatal Fc receptor

    • FcγR
      Fc gamma receptor

    • IgG
      immunoglobulin G

    • IL-6
      Interleukin-6

    • IL-6R
      Interleukin-6 receptor

    • LGI1
      Leucine-rich glioma-inactivated 1

    • mAb
      Monoclonal antibody

    • mIL-6R
      membrane-bound IL-6 receptor

    • MOG-AD
      Myelin oligodendrocyte glycoprotein antibody disease

    • NMDAR
      N-methyl-D-aspartic acid receptor

    • NMOSD
      Neuromyelitis optica spectrum disorder

    • sIL-6R
      soluble IL-6 receptor

    +