Company to hold investor event on May 9th
GAITHERSBURG, Md.–(BUSINESS WIRE)–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.
Forward-Looking Statements
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, future operations,
prospects, plans, objectives of management, and the timing and progress
of clinical development of our product candidates, 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.
________________________
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.
Contacts
Investors:
Solebury Trout
Chad Rubin
646-378-2947
crubin@soleburytrout.com
Media:
Solebury Trout
Amy Bonanno
914-450-0349
abonanno@soleburytrout.com