Viela Bio today announced that data from a pivotal study of its anti-CD19 monoclonal antibody inebilizumab in patients with neuromyelitis optica spectrum disorder (NMOSD), were selected for presentation during the Clinical Trials Plenary Session at the 2019 American Academy of Neurology (AAN 2019) Annual Meeting. AAN 2019 will take place on May 2-10 in Philadelphia.
“We are pleased that clinical results with inebilizumab in patients with NMOSD will be highlighted in an oral presentation during the plenary session at AAN 2019,” said Bing Yao, Ph.D. Executive Chairman and Chief Executive Officer. “This study represents the largest monotherapy trial ever conducted in NMOSD and we look forward to sharing details with physicians, patients and others in this rare disease community.”
Title: “Randomized Controlled Trial of Inebilizumab in Neuromyelitis Optica Spectrum Disorder”
Speaker: Bruce Cree, M.D., Ph.D., MCR, FAAN
Date: Tuesday, May 7th, 2019
Time: 9:30 a.m. EDT
About Neuromyelitis Optica Spectrum Disorders (NMOSD)
NMOSD is a recently proposed unifying term for neuromyelitis optica (NMO)—also known as Devic’s disease—and related syndromes. NMOSD is a rare, severe, relapsing, neuroinflammatory autoimmune disease that can be fatal. In NMOSD, about 80% of patients have autoantibodies to a water channel protein called aquaporin-4 (AQP4). These AQP4-IgG autoantibodies are produced by plasmablasts and plasma cells and bind primarily to astrocytes in the central nervous system. Binding of AQP4-IgG antibodies to central nervous system cells is believed to trigger attacks, which can damage the optic nerves, spinal cord and brain. Loss of vision, paralysis, loss of sensation, bladder and bowel dysfunction, nerve pain, and respiratory failure can all be manifestations of the disease. Each NMOSD attack leads to further damage and disability. NMOSD occurs more commonly in women and it may be more common in non-Caucasians. There is currently no cure or approved treatment for NMOSD.
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 the circulation.
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 received inebilizumab every 6 months. The primary endpoint was time from treatment initiation to occurrence of an NMOSD attack. NMOSD attack diagnosis was standardized using 18 clinically meaningful criteria that were developed for the study. An independent, blinded external adjudication committee reviewed all NMOSD attacks. An open-label study is ongoing, with patients receiving an inebilizumab infusion every 6 months. More information can be found on clinicaltrials.gov
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