The Lancet publishes results from the pivotal study of inebilizumab in patients with neuromyelitis optica spectrum disorder

Viela Bio announced that peer-reviewed journal, The Lancet, has published results from its pivotal study of inebilizumab in patients with neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a rare, severe, relapsing, neuroinflammatory autoimmune disease that can result in severe muscle weakness and paralysis, loss of vision, respiratory failure and neuropathic pain.

The N-MOmentum trial , the largest global, placebo-controlled study in NMOSD with 231 enrolled patients, met its primary endpoint and a majority of secondary endpoints. The study results, which were presented at a plenary session of the annual meeting of the American Academy of Neurology (AAN), demonstrated significant reduction in risk of NMOSD attack and reduced disability scores as measured by expanded disability status scale, hospitalizations and new central nervous system MRI lesions. The paper, entitled “Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmemtum): a double-blind, randomised placebo-controlled phase II/III trial,” is now available and will be published in a future print edition of The Lancet. .

Efficacy Results from N-MOmentum Study : Inebilizumab met the primary efficacy endpoint with a 77% reduction in risk of developing an NMOSD attack when compared to placebo in AQP4-IgG seropositive patients after 28 weeks of treatment (HR: 0.227; p < 0.0001)i. Similar effect on attack risk (73% reduction) was seen in the total inebilizumab-treated patient population, inclusive of AQP4-IgG seronegative patients, (HR: 0.272; p < 0.0001). At the end of the randomized-controlled period (RCP), 89% of AQP4-IgG seropositive patients treated with inebilizumab were attack-free, versus 58% in the placebo group. Inebilizumab demonstrated statistically significant benefits in key secondary endpoints, including: Reduction in worsening from baseline in Expanded Disability Status Scale (EDSS) scores: inebilizumab-treated patients (15.5%), versus placebo (33.9%, p=0.0049). Reduction in NMOSD-related hospitalizations: inebilizumab-treated patients (10/174 subjects) versus placebo (8/56 subjects) (p=0.01; rate ratio: 0.286) Reduction in frequency of cumulative total active MRI lesions: inebilizumab-treated patients (79/174 subjects) versus placebo (32/56 subjects) (p=0.0034; rate ratio: 0.566) Visual acuity, also a secondary endpoint, did not demonstrate a statistically significant difference.

Comment:The FDA granted inebilizumab Orphan Drug Designation in 2016 and Breakthrough Therapy Designation in 2019. The European Medicines Agency (EMA) granted inebilizumab Orphan Drug Designation in 2017. The FDA accepted for review Viela’s Biologics License Application for inebilizumab on 27 August 2019.

See_ "Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised placebo-controlled phase 2/3 trial"-Bruce A C Cree, Jeffrey L Bennett, Ho Jin Kim, Brian G Weinshenker, Sean J Pittock, Dean M Wingerchuk, and others The Lancet Published: September 5, 2019.