Viela reports detailed Phase II/III data for rare CNS disorder therapy

Viela touted a potential dosing advantage and reiterated its plans to submit mid-year a BLA to FDA for inebilizumab to treat neuromyelitis optica spectrum disorder (NMOSD). The update came during a presentation at AAN on Tuesday in which the company reported detailed data from the Phase II/III N-MOmentum trial of the humanized mAb against CD19 in the indication.

In January, Viela Bio Inc. (Gaithersburg, Md.) said inebilizumab (MEDI-551) as monotherapy significantly reduced the risk of developing an NMOSD attack, the primary endpoint, by 77% at week 28 vs. placebo among AQP4-IgG seropositive patients (see "Viela Planning BLA Submission for Inebilizumab in Rare CNS Disorder")...