Inebilizumab as a Treatment for NMOSD and Autoimmune ... - Neurology Live

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"Inebilizumab is the target agent in this clinical trial. It's supported by human evidence that comes from a treatment trial in NMO—neuromyelitis optica—and other antibody mediated diseases. In that case, targeting the aquaporin-4 receptor and astrocytes."

In June 2020, inebilizumab (Uplizna; Horizon) was approved for the treatment of neuromyelitis optica spectrum disorder (NMOSD) supported by results in 231 patients with NMOSD from the N-MOmentum trial (NCT02200770).¹ The findings demonstrated a 77% reduction in the risk of NMOSD relapse in the treatment group compared with placebo. Beside the treatment of NMOSD, inebilizumab has some potential as a therapy for N-methyl-D-aspartate receptor (NMDAR) encephalitis.

Lead investigator Gregory Day, MD, MSc, MSCI, FAAN, and colleagues of the upcoming ExTINGUISH (NCT04372615) plan to investigate the safety and efficacy of inebilizumab (300 mg) as a therapy for moderate-to-severe NMDAR encephalitis.² For enrollment, researchers plan to include 120 patients from 22 sites (United States, n = 20; Europe, n = 2). Prior to being randomized, participants will receive standard first-line immunotherapies, and then, after 6 weeks, cyclophosphamide IV rescue therapy will be administered if patients fail to respond to the treatment.

In a recent interview, Day, a neurologist at Mayo Clinic, in Jacksonville, Florida, sat down with NeurologyLive® to discuss more about the standard of care for patients with autoimmune diseases such as NMOSD and autoimmune encephalitis. He also talked about further details of the trial plans, and about what he believes clinicians and patients are hoping for when it comes to ExTINGUISH's assessment of inebilizumab.

REFERENCES
1. FDA Approves New Therapy for Rare Disease Affecting Optic Nerve, Spinal Cord. News release. FDA. June 11, 2020. Accessed March 15, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-new-therapy-rare-disease-affecting-optic-nerve-spinal-cord
2. Day G, Titulaer M, Wong KH, et al. The ExTINGUISH Trial: A Phase-2B Randomized Placebo-Controlled Trial of Inebilizumab in Anti-NMDA Receptor Encephalitis (P5-1.004). Neurology. Published May 2022, 98 (18 Supplement) 1651.

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