GAITHERSBURG, Md.--(BUSINESS WIRE)--Viela Bio today announced that peer-reviewed journal, The Lancet, has published results from its pivotal study of inebilizumab in patients with neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a rare, severe, relapsing, neuroinflammatory autoimmune disease that can result in severe muscle weakness and paralysis, loss of vision, respiratory failure and neuropathic pain.
The N-MOmentum trial, the largest global, placebo-controlled study in NMOSD with 231 enrolled patients, met its primary endpoint and a majority of secondary endpoints. The study results, which were presented at a plenary session of the annual meeting of the American Academy of Neurology (AAN), demonstrated significant 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.
The paper, entitled “Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmemtum): a double-blind, randomised placebo-controlled phase 2/3 trial,” is now available and will be published in a future print edition of The Lancet.
“We’re pleased that these important results are now fully available to the greater neuroinflammatory and autoimmune disease communities,” said Jorn Drappa, M.D., Ph.D., Chief Medical Officer and Head of Research & Development at Viela Bio. “This study provided key information on the safety and efficacy profile of inebilizumab monotherapy in NMOSD. Inebilizumab is the first and only biologic to use CD19 as a target for B cell depletion in this devastating disease.”
Continued Dr. Drappa: “The results from this pivotal study are very encouraging, demonstrating the potential impact on patient care if inebilizumab is approved by the U.S. Food and Drug Administration.”
The FDA granted inebilizumab Orphan Drug Designation in 2016 and Breakthrough Therapy Designation in 2019. The European Medicines Agency (EMA) granted inebilizumab Orphan Drug Designation in 2017. The FDA accepted for review Viela’s Biologics License Application for inebilizumab in August 2019.
Efficacy Results from N-MOmentum Study
Below is a summary of the study results, as presented at AAN:
- Inebilizumab met the primary efficacy endpoint with a 77% reduction in risk of developing an NMOSD attack when compared to placebo in AQP4-IgG seropositive patients after 28 weeks of treatment (HR: 0.227; p < 0.0001)i.
- Similar effect on attack risk (73% reduction) was seen in the total inebilizumab-treated patient population, inclusive of AQP4-IgG seronegative patients (HR: 0.272; p < 0.0001)
- At the end of the randomized-controlled period (RCP), 89% of AQP4-IgG seropositive patients treated with inebilizumab were attack-free versus 58% in the placebo group
- Inebilizumab demonstrated statistically significant benefits in key secondary endpoints, including:
--Reduction in worsening from baseline in Expanded Disability Status Scale (EDSS) scores: inebilizumab-treated patients (15.5%) versus placebo (33.9%, p=0.0049)
--Reduction in NMOSD-related hospitalizations: inebilizumab-treated patients (10/174 subjects) versus placebo (8/56 subjects) (p=0.01; rate ratio: 0.286)
--Reduction in frequency of cumulative total active MRI lesions: inebilizumab-treated patients (79/174 subjects) versus placebo (32/56 subjects) (p=0.0034; rate ratio: 0.566)
Visual acuity, also a secondary endpoint, did not demonstrate a statistically significant difference.
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 nerve, 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 may be more common in individuals of African and Asian descent. There is currently no cure 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 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 an 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.
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, product candidates, future operations, prospects, plans, objectives of management, the timing and progress of clinical development of our product candidates, and the benefits of inebilizumab to patients with NMOSD are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue” or the negative of these terms or other comparable terminology, which are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
i Data on File. Viela Bio. Gaithersburg, MD. March 2019.