January 22, 2019
Viela Bio Announces Endpoints in Trial in Patients with NMOSD
Largest controlled monotherapy trial in NMOSD demonstrates reduction in risk of attacks and reduction in worsening of disability in patients treated with inebilizumab.
Viela Bio today announced that N-MOmentum, a pivotal trial of inebilizumab, met its primary and key secondary endpoints in patients with neuromyelitis optica spectrum disorder (NMOSD). The N-MOmentum trial is a randomized, double-masked, placebo-controlled, global registration study that enrolled 231 patients with NMOSD—a rare, life-threatening autoimmune disease affecting the central nervous system.
“These results support our hypothesis that CD19 expressing B cells including plasmablasts and plasma cells play a key role in the pathogenesis of NMOSD,” said Jorn Drappa, M.D., Ph.D., Chief Medical Officer and Head of Research & Development at Viela Bio. “This study demonstrated a highly significant and clinically meaningful reduction in attack risk and suggests a promising new treatment for patients diagnosed with NMOSD. We would like to thank the investigators, hospitals and most of all the patients who took part in this trial, without whom medical advancements would not be possible.”
Neuromyelitis Optica Spectrum Disorder (NMOSD) is a rare life threatening relapsing autoimmune disorder that preferentially causes inflammation in the optic nerve and spinal cord. “The N-MOmentum trial is the largest controlled trial in NMOSD ever conducted with participants from 24 countries spanning the globe. Importantly, this trial studied inebilizumab as monotherapy, free from the confounding influence of other background immunosuppressive treatments. The results provide unambiguous evidence of a large reduction in the risk of attack. The results also showed a highly beneficial impact of inebilizumab on disability,” said Dr. Bruce Cree, M.D., Ph.D., MAS, the lead investigator for the N-MOmentum study and Professor of Clinical Neurology at the UCSF Weill Institute for Neurosciences, San Francisco, CA.
[Originally posted by Business Wire — January 3, 2019]