Largest controlled monotherapy trial in NMOSD demonstrates reduction in risk of attacks and reduction in worsening of disability in patients treated with inebilizumab
GAITHERSBURG, MA, USA I January 3, 2019 I 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.
The primary analysis demonstrated a 77% reduction in the risk of developing an NMOSD attack in patients treated with inebilizumab monotherapy compared to placebo. Furthermore, secondary analysis demonstrated a reduction in worsening of disability in patients treated with inebilizumab compared to placebo. The safety and tolerability profiles for inebilizumab were acceptable and consistent with previous experience. Additional details from the N-MOmentum trial will be presented at a medical meeting in 2019.
“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.”
NMOSD is a rare, life-threatening autoimmune disease of the central nervous system in which the body’s immune system attacks healthy cells, most commonly in the optic nerves and spinal cord, resulting in severe damage. NMOSD may cause severe muscle weakness and paralysis, loss of vision, respiratory failure, problems with bowel and bladder function and neuropathic pain.1 There is currently no cure or approved treatment for NMOSD.
“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.
The U.S. Food and Drug Administration granted Orphan Drug Designation for inebilizumab for the treatment of patients with NMOSD in March 2016. The European Medicines Agency granted orphan designation to inebilizumab for the treatment of NMOSD in March 2017.
[1] National Institute of Neurological Disorders and Stroke, National Institutes of Health https://www.ninds.nih.gov/Disorders/All-Disorders/Neuromyelitis-Optica-Information-Page
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.
About Inebilizumab
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.
About N-MOmentum
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 placed 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.
SOURCE: Viela Bio
Post Views: 26
Largest controlled monotherapy trial in NMOSD demonstrates reduction in risk of attacks and reduction in worsening of disability in patients treated with inebilizumab
GAITHERSBURG, MA, USA I January 3, 2019 I 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.
The primary analysis demonstrated a 77% reduction in the risk of developing an NMOSD attack in patients treated with inebilizumab monotherapy compared to placebo. Furthermore, secondary analysis demonstrated a reduction in worsening of disability in patients treated with inebilizumab compared to placebo. The safety and tolerability profiles for inebilizumab were acceptable and consistent with previous experience. Additional details from the N-MOmentum trial will be presented at a medical meeting in 2019.
“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.”
NMOSD is a rare, life-threatening autoimmune disease of the central nervous system in which the body’s immune system attacks healthy cells, most commonly in the optic nerves and spinal cord, resulting in severe damage. NMOSD may cause severe muscle weakness and paralysis, loss of vision, respiratory failure, problems with bowel and bladder function and neuropathic pain.1 There is currently no cure or approved treatment for NMOSD.
“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.
The U.S. Food and Drug Administration granted Orphan Drug Designation for inebilizumab for the treatment of patients with NMOSD in March 2016. The European Medicines Agency granted orphan designation to inebilizumab for the treatment of NMOSD in March 2017.
[1] National Institute of Neurological Disorders and Stroke, National Institutes of Health https://www.ninds.nih.gov/Disorders/All-Disorders/Neuromyelitis-Optica-Information-Page
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.
About Inebilizumab
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.
About N-MOmentum
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 placed 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.
SOURCE: Viela Bio
Post Views: 26
