The clinical research director at the UCSF Multiple Sclerosis Center discussed the efficacy of inebilizumab (Uplizna; Viela Bio) and biomarker data observed in the N-Momentum trial in NMOSD.
“It’s a very high bar to be able to show an effect on the modified Rankin Scale. It’s never been done with any product in MS, but it was done with inebilizumab in the N-Momentum trial.”
The recent FDA approval of inebilizumab (Uplizna; Viela Bio) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) was supported by the findings from the N-Momentum study (NCT02200770). Over the course of the study, the risk of NMOSD relapse was reduced by 77% in the treatment group compared with placebo.
For Bruce Cree, MD, PhD, MAS, lead investigator of the study, what sets this agent apart from the approved eculizumab (Soliris; Alexion) and the investigational satralizumab (Roche) is its impact on disability. In the trial, Cree explained, there was a clear positive effect on disability measured by both the Expanded Disability Status Scale (EDSS) and modified Rankin Scale (mRS)—the latter of which sets “a rather high bar” for showing such results.
Cree, who is also clinical research director at UCSF Multiple Sclerosis Center, and professor of clinical neurology at UCSF Weill Institute for Neurosciences, told NeurologyLive in this interview that the trial also invested effort into assessing a number of biomarkers. He offered insight into those findings and expanded on the hypothesis the findings raised for him related to B cell measurement.
FDA Approves New Therapy for Rare Disease Affecting Optic Nerve, Spinal Cord. News release. FDA. June 11, 2020. Accessed June 19, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-new-therapy-rare-disease-affecting-optic-nerve-spinal-cord