GAITHERSBURG, Md.–(BUSINESS WIRE)–Viela Bio today announced that data from the N-MOmentum trial—the largest global, placebo-controlled study conducted in patients with neuromyelitis optica spectrum disorder (NMOSD)—have been selected for an oral plenary session presentation as well as poster presentations at the upcoming 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The congress will be held in Stockholm, Sweden, September 11-13, 2019.
“We are pleased that results from our N-MOmentum trial were selected for presentation at ECTRIMS—the largest global congress dedicated to research advances in neurological diseases—providing a platform to further share data regarding inebilizumab as a potential therapy for patients with NMOSD,” said Jorn Drappa, M.D., Ph.D., Chief Medical Officer and Head of Research & Development at Viela Bio. “Among the highlights to be presented at the congress are the long-term results from our open-label extension study, building on the previously reported data which demonstrated a 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 when compared to placebo.” The U.S. Food and Drug Administration recently accepted for review Viela Bio’s Biologics License Application for inebilizumab for the treatment of patients with NMOSD.
Oral Plenary Presentation
Title: The N-MOmentum Study–A Randomised, Placebo-Controlled, Double-Blind Trial of Inebilizumab for Neuromyelitis Optica Spectrum Disorder: Randomised Controlled Period and Open-label Extension Results
Date: Thursday, September 12, 2019
Time: 08:30 – 08:42 CEST
Late-Breaking Poster Presentations
Title: Sensitivity Analyses of Time to Adjudicated Attacks in the N-MOmentum Study, a Randomized, Placebo-Controlled, Double-Masked Trial in Patients with Neuromyelitis Optica Spectrum Disorder
Date: Friday, September 13, 2019
Time: 12:15 – 14:15 CEST
Title: Elevated Serum Glial Fibrillary Acidic Protein (sGFAP) is Associated with Increased Risk of Neuromyelitis Optica Spectrum Disorder Attacks in the N-MOmentum Randomised, Masked, Placebo-Controlled Clinical Trial of Inebilizumab
Date: Friday, September 13, 2019
Time: 12:15 – 14:15 CEST
Additional Poster Presentations
Title: Inebilizumab Reduces Worsening of Disability in Neuromyelitis Optica Spectrum Disorder: Outcomes from the N-MOmentum Randomized, Placebo-Controlled, Double-Masked Trial
Title: Diagnosis, Severity, and Recovery of Attacks in the N-MOmentum Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder
Title: Characterization of B-Cell Subset Changes Following Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) with Inebilizumab: Results from the N-MOmentum Study Randomized Control Period
Inebilizumab is a humanized monoclonal antibody that binds with high affinity to CD19, a protein expressed on a broad range of B cells, including antibody-secreting plasmablasts and plasma cells. After binding to CD19, these cells are rapidly depleted from circulation. Inebilizumab is an investigational new drug for which there is no marketing authorization.
The N-MOmentum study enrolled 231 NMOSD patients, including patients with and without AQP4-IgG antibodies. Patients were randomized to receive two intravenous doses of inebilizumab monotherapy or placebo and followed for 6.5 months. Patients were subsequently given the option to enter into open-label extension in which all patients receive inebilizumab every 6 months. The primary endpoint was time from treatment initiation to occurrence of an NMOSD attack, which was reviewed by an independent, blinded external Adjudication Committee. NMOSD attack diagnosis was standardized using 18 clinically meaningful criteria that were developed for the study. The open-label extension portion of the study is ongoing. More information can be found on clinicaltrials.gov (Study NCT02200770).
About Viela Bio
Viela Bio, headquartered in Gaithersburg, Maryland, is a clinical-stage biotechnology company pioneering and advancing treatments for severe inflammation and autoimmune diseases by selectively targeting shared critical pathways that are the root cause of disease.
For more information, please visit www.vielabio.com
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