GAITHERSBURG, MD, USA I May 07, 2019 I Viela Bio today announced results from a pivotal study of its anti-CD19 monoclonal antibody, inebilizumab, in patients with neuromyelitis optica spectrum disorder (NMOSD) — a rare autoimmune disease characterized by unpredictable attacks that often lead to severe, irreparable disability including blindness and paralysis. Results were presented today during the Clinical Trials Plenary Session at the 2019 American Academy of Neurology (AAN 2019) Annual Meeting held in Philadelphia from May 4-10.
The N-MOmentum trial, the largest global, placebo study in NMOSD, achieved the primary and key secondary endpoints, demonstrating significant reduction in risk of NMOSD attack, and impacting measurements of worsening disability, hospitalizations and new central nervous system MRI lesions.
“The N-MOmentum trial demonstrated the statistically significant and clinically meaningful treatment effect of inebilizumab across both the primary endpoint and key secondary endpoints. Inebilizumab is the first and only biologic in NMOSD to use CD19 as a target for B cell depletion without the confounding effects of background drug therapies,” said Bruce Cree, M.D., Ph.D., MAS, the lead investigator for the N-MOmentum study and Professor of Clinical Neurology at the University of California San Francisco Weill Institute for Neurosciences. “Inebilizumab substantially reduced the risk of attacks when given as a monotherapy, successfully measuring a strong treatment effect in both attacks and worsening disability.”
Efficacy Results
- 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)1.
- 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.
Inebilizumab demonstrated a favorable safety and tolerability profile, with an adverse event rate similar to placebo. Rates of serious and/or ≥ Grade 3 severity adverse events were similar in the inebilizumab (10.3%) and placebo (14.3%) groups.
“NMOSD is a devastating disease that can result in severe muscle weakness and paralysis, loss of vision, respiratory failure and neuropathic pain. There is currently no approved treatment, and patients today are relegated to off-label therapies with uncertain benefit,” said Jorn Drappa, M.D., Ph.D., Chief Medical Officer and Head of Research & Development at Viela Bio. “The results of the N-MOmentum study are promising, and have the potential to reshape the treatment paradigm in NMOSD. We look forward to working with the regulatory agencies to understand how inebilizumab can become part of a dedicated therapeutic regimen for people living with this devastating disease.”
The N-MOmentum study enrolled 231 NMOSD patients, including patients with and without the AQP4-IgG antibody, a key biomarker for the disease2. Patients were randomized 3:1 (inebilizumab to placebo) to receive either two introductory doses of 300 mg of inebilizumab monotherapy or placebo at Day 1 and Day 15. The patients were followed for a total of 28 weeks, after which time the RCP was stopped early for efficacy. Following the RCP, patients were given the option to enter an open-label extension period, in which they receive 300 mg of inebilizumab every 6 months.
Based on the safety and efficacy data from this pivotal study, the company plans to file for a Biologics License Application with the U.S. Food and Drug Administration (FDA) mid-2019. The FDA granted inebilizumab Orphan Drug Designation for the treatment of NMOSD in 2016 and Breakthrough Therapy Designation in 2019 for the treatment of NMOSD. The European Medicines Agency (EMA) granted inebilizumab Orphan Drug Designation in 2017.
Investor Event
Viela Bio will host a live investor event on May 9, 2019 at 5:30 p.m. EDT in New York City, which will feature the N-MOmentum lead investigator, Dr. Bruce Cree, as well as Viela Bio senior management.
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, the 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 circulation. Inebilizumab is an investigational new drug for which there is no marketing authorization in the U.S.
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 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 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.
________________________
1 Data on File. Viela Bio. Gaithersburg, MD. March 2019.
2 Cree BA, Bennett JL, Sheehan M, Cohen J, Hartung HP, Aktas O, Kim HJ, Paul F, Pittock S, Weinshenker B, Wingerchuk D, Fujihara K, Cutter G, Patra K, Flor A, Barron G, Madani S, Ratchford JN, Katz E. Placebo-controlled study in neuromyelitis optica-Ethical and design considerations. Mult Scler. 2016 Jun;22(7):862-72. doi: 10.1177/1352458515620934. Epub 2015 Dec 14., Data on File. Viela Bio. Gaithersburg, MD. March 2019.
SOURCE: Viela Bio
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GAITHERSBURG, MD, USA I May 07, 2019 I Viela Bio today announced results from a pivotal study of its anti-CD19 monoclonal antibody, inebilizumab, in patients with neuromyelitis optica spectrum disorder (NMOSD) — a rare autoimmune disease characterized by unpredictable attacks that often lead to severe, irreparable disability including blindness and paralysis. Results were presented today during the Clinical Trials Plenary Session at the 2019 American Academy of Neurology (AAN 2019) Annual Meeting held in Philadelphia from May 4-10.
The N-MOmentum trial, the largest global, placebo study in NMOSD, achieved the primary and key secondary endpoints, demonstrating significant reduction in risk of NMOSD attack, and impacting measurements of worsening disability, hospitalizations and new central nervous system MRI lesions.
“The N-MOmentum trial demonstrated the statistically significant and clinically meaningful treatment effect of inebilizumab across both the primary endpoint and key secondary endpoints. Inebilizumab is the first and only biologic in NMOSD to use CD19 as a target for B cell depletion without the confounding effects of background drug therapies,” said Bruce Cree, M.D., Ph.D., MAS, the lead investigator for the N-MOmentum study and Professor of Clinical Neurology at the University of California San Francisco Weill Institute for Neurosciences. “Inebilizumab substantially reduced the risk of attacks when given as a monotherapy, successfully measuring a strong treatment effect in both attacks and worsening disability.”
Efficacy Results
- 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)1.
- 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.
Inebilizumab demonstrated a favorable safety and tolerability profile, with an adverse event rate similar to placebo. Rates of serious and/or ≥ Grade 3 severity adverse events were similar in the inebilizumab (10.3%) and placebo (14.3%) groups.
“NMOSD is a devastating disease that can result in severe muscle weakness and paralysis, loss of vision, respiratory failure and neuropathic pain. There is currently no approved treatment, and patients today are relegated to off-label therapies with uncertain benefit,” said Jorn Drappa, M.D., Ph.D., Chief Medical Officer and Head of Research & Development at Viela Bio. “The results of the N-MOmentum study are promising, and have the potential to reshape the treatment paradigm in NMOSD. We look forward to working with the regulatory agencies to understand how inebilizumab can become part of a dedicated therapeutic regimen for people living with this devastating disease.”
The N-MOmentum study enrolled 231 NMOSD patients, including patients with and without the AQP4-IgG antibody, a key biomarker for the disease2. Patients were randomized 3:1 (inebilizumab to placebo) to receive either two introductory doses of 300 mg of inebilizumab monotherapy or placebo at Day 1 and Day 15. The patients were followed for a total of 28 weeks, after which time the RCP was stopped early for efficacy. Following the RCP, patients were given the option to enter an open-label extension period, in which they receive 300 mg of inebilizumab every 6 months.
Based on the safety and efficacy data from this pivotal study, the company plans to file for a Biologics License Application with the U.S. Food and Drug Administration (FDA) mid-2019. The FDA granted inebilizumab Orphan Drug Designation for the treatment of NMOSD in 2016 and Breakthrough Therapy Designation in 2019 for the treatment of NMOSD. The European Medicines Agency (EMA) granted inebilizumab Orphan Drug Designation in 2017.
Investor Event
Viela Bio will host a live investor event on May 9, 2019 at 5:30 p.m. EDT in New York City, which will feature the N-MOmentum lead investigator, Dr. Bruce Cree, as well as Viela Bio senior management.
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, the 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 circulation. Inebilizumab is an investigational new drug for which there is no marketing authorization in the U.S.
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 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 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.
________________________
1 Data on File. Viela Bio. Gaithersburg, MD. March 2019.
2 Cree BA, Bennett JL, Sheehan M, Cohen J, Hartung HP, Aktas O, Kim HJ, Paul F, Pittock S, Weinshenker B, Wingerchuk D, Fujihara K, Cutter G, Patra K, Flor A, Barron G, Madani S, Ratchford JN, Katz E. Placebo-controlled study in neuromyelitis optica-Ethical and design considerations. Mult Scler. 2016 Jun;22(7):862-72. doi: 10.1177/1352458515620934. Epub 2015 Dec 14., Data on File. Viela Bio. Gaithersburg, MD. March 2019.
SOURCE: Viela Bio
Post Views: 14
