First-and-only FcRn blocker to demonstrate
superiority in activities of daily living
(MG-ADLa) over placebo when added to
standard of care over 24 weeks in antibody positive patients:
anti-AChR+, anti-MuSK+, anti-LRP4+
HELSINKI, June 28,
2024 /PRNewswire/ -- Johnson & Johnson
(NYSE: JNJ) today announced positive results from the nipocalimab
Phase 3 Vivacity-MG3 study in patients with generalized myasthenia
gravis (gMG). Patients treated with nipocalimab plus standard of
care (SOC) achieved superiority over placebo plus SOC as measured
by the primary endpoint of improvement in the MG-ADL score from
baseline over 24 weeks. These data are included in a presentation
and are among eight abstracts that Johnson & Johnson will
present at the European Academy of Neurology (EAN) 2024
Congress1 and will be included in submissions to
regulatory authorities later this year.
Experience the full interactive Multichannel News Release here:
https://www.multivu.com/players/English/9276951-johnson-and-johnson-nipocalimab-results-myasthenia-gravis-ean-2024
"The sustained response of nipocalimab over six months among
this broad myasthenia gravis population is an important finding
given the chronic, unpredictable exacerbations typically seen with
myasthenia gravis," said Carlo
Antozzi, M.D., Neuroimmunology and Muscle Pathology Unit of
the Neurological Institute Foundation C. Besta of Milan, Italyb. "We are encouraged
by the potential of nipocalimab to uniquely help address this gap
for people living with myasthenia gravis."
The double-blind placebo-controlled study enrolled a broad
population of anti-AChR+, anti-MuSK+ and/or anti-LRP4+ patients,
which account for approximately 95 percent of the gMG patient
population.2 Patients receiving nipocalimab plus
SOC improved by 4.70 points on the MG-ADL, significantly more than
the 3.25 point improvement from baseline observed with placebo plus
SOC from baseline over Weeks 22, 23 and 24
(P=0.002)c. For someone living with gMG, a 1- to
2-point change on MG-ADL may be the difference between normal
eating and frequent choking on food, or shortness of breath at rest
and being on a ventilator.3 In addition to
achieving this primary endpoint, critical secondary endpoints were
also met:
- Improvement in strength and function of different muscle
groups, as measured by QMGd, was significantly greater
with nipocalimab plus SOC compared with placebo plus SOC over Weeks
22 and 24 (P<0.001)e.
- MG-ADL response (≥2-point improvement from baseline) was
significantly greater in nipocalimab plus SOC compared with placebo
plus SOC (P=0.021) over Weeks 22, 23 and 24, further
underscoring the potential of treatment with nipocalimab to
mitigate the impact of gMG on a patient's day-to-day life.
Safety and tolerability were consistent with other nipocalimab
studies. The overall incidence of adverse events, serious adverse
events and adverse events leading to discontinuation was similar to
that in the placebo plus current SOC group.
"We are thrilled to present yet another dataset for nipocalimab
at the EAN 2024 Annual Meeting highlighting our commitment to
providing innovative treatments for autoantibody-driven diseases,"
said Katie Abouzahr, M.D., Vice
President, Autoantibody and Maternal Fetal Immunology Disease Area
Leader, Johnson & Johnson Innovative Medicine. "We are
developing transformative therapies that have the potential to
address significant unmet patient need."
Editor's notes:
a. MG-ADL (Myasthenia Gravis – Activities of Daily Living)
provides a rapid clinical assessment of the patient's recall of
symptoms impacting activities of daily living, with a total score
range of 0 to 24; a higher score indicates greater symptom
severity.
b. Dr. Antozzi is a paid consultant for Johnson &
Johnson. He has not been compensated for any media work.
c. Patients who received nipocalimab plus current SOC had
a mean change of -4.70 [standard error (SE) 0.329]. Patients on
placebo plus current SOC had a mean change of -3.25 (SE 0.335);
difference of least-squares (LS) means -1.45
[0.470]; P=0.002.
d. QMG (Quantitative Myasthenia Gravis) is a 13-item
assessment by a clinician that quantifies MG disease severity. The
total QMG score ranges from 0 to 39, where higher scores indicated
greater disease severity.
e. Patients who received nipocalimab had an average score
of -4.86 (SE 0.504) from baseline over Weeks 22, 23 and 24.
Patients randomized to placebo plus current SOC had an average
score of -2.05 (SE 0.499); difference of LS means
-2.81; P<0.001.
ABOUT GENERALIZED MYASTHENIA GRAVIS (gMG)
Myasthenia gravis (MG) is an autoantibody disease in which
autoantibodies target proteins at the neuromuscular junction,
disrupt neuromuscular signaling, and impair or prevent muscle
contraction.4 In MG, the immune system mistakenly
attacks muscle receptors by producing anti-receptor antibodies
(e.g., anti-acetylcholine receptor [AChR], anti-muscle-specific
tyrosine kinase [MuSK] or anti-low density lipoprotein-related
protein 4 [LRP4]) that can block or destroy these muscle receptors,
preventing signals from transferring from nerves to
muscles.5 The disease impacts an estimated 700,000
people worldwide. Initial disease manifestations are usually ocular
but in 53 percent or more,6,7 the disease
generalizes (gMG) which is characterized by fluctuating weakness of
the skeletal muscles leading to symptoms like limb weakness,
drooping eyelids, double vision, and difficulties with chewing,
swallowing, speech, and breathing.8,9 Although gMG
may be managed with current SOC therapies, research is needed to
develop new treatments for those who may not respond well enough to
or tolerate those therapies.
ABOUT THE PHASE 3 VIVACITY-MG3 STUDY
The Phase 3 Vivacity-MG3 study was specifically designed to
measure sustained efficacy and safety with consistent dosing in
this unpredictable chronic condition where unmet need remains high.
Antibody positive or negative adult gMG patients with insufficient
response (MG-ADL ≥6) to ongoing SOC therapy were identified and 199
patients,153 of which were antibody positive, enrolled in the
24-week double-blind placebo-controlled trial. Randomization was
1:1, nipocalimab plus current SOC (30 mg/kg IV loading dose
followed by 15 mg/kg every two weeks) or placebo plus current SOC.
Baseline demographics were balanced across arms (77 nipocalimab, 76
placebo). The primary endpoint of the study was mean change in
MG-ADLa score from baseline over Weeks 22, 23 and
24 in antibody positive patients. A key secondary endpoint included
change in QMGc score. Long-term safety and efficacy
were further assessed in an ongoing OLE phase.10
ABOUT NIPOCALIMAB
Nipocalimab is an investigational monoclonal antibody,
purposefully designed to bind with high affinity to block FcRn and
reduce levels of circulating immunoglobulin G (IgG) antibodies,
while preserving immune function without causing broad
immunosuppression. This includes autoantibodies and alloantibodies
that underlie multiple conditions across three key segments in the
autoantibody space including Rare Autoantibody diseases, Maternal
Fetal diseases mediated by maternal alloantibodies and Prevalent
Rheumatology.10,11,12,13,14,15,16,17,18 Blockade of
IgG binding to FcRn in the placenta is also believed to prevent
transplacental transfer of maternal alloantibodies to the
fetus.19,20
The U.S. Food and Drug Administration (FDA) and European
Medicines Agency (EMA) have granted several key designations to
nipocalimab including:
- Fast Track designation in hemolytic disease of the fetus and
newborn (HDFN) and warm autoimmune hemolytic anemia (wAIHA) in
July 2019, gMG in December 2021 and fetal neonatal alloimmune
thrombocytopenia (FNAIT) in March
2024
- Orphan drug status for wAIHA in December
2019, HDFN in June 2020, gMG
in February 2021, chronic
inflammatory demyelinating polyneuropathy CIDP in October 2021 and FNAIT in December 2023
- Breakthrough Therapy designation for HDFN by the FDA in
February 2024
- Orphan medicinal product designation for HDFN by the EMA in
October 2019
ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything. Our
strength in healthcare innovation empowers us to build a world
where complex diseases are prevented, treated, and cured, where
treatments are smarter and less invasive, and solutions are
personal. Through our expertise in Innovative Medicine and MedTech,
we are uniquely positioned to innovate across the full spectrum of
healthcare solutions today to deliver the breakthroughs of
tomorrow, and profoundly impact health for humanity.
Learn more at https://www.jnj.com/ or
at www.janssen.com/johnson-johnson-innovative-medicine.
Follow us at @JanssenUS and @JNJInnovMed.
Janssen Research & Development, LLC and Janssen Biotech,
Inc. are Johnson & Johnson companies.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995
regarding product development and the potential benefits and
treatment impact of nipocalimab. The reader is cautioned not to
rely on these forward-looking statements. These statements are
based on current expectations of future events. If underlying
assumptions prove inaccurate or known or unknown risks or
uncertainties materialize, actual results could vary materially
from the expectations and projections of Janssen Research &
Development, LLC, Janssen Biotech, Inc. and/or Johnson &
Johnson. Risks and uncertainties include, but are not limited to:
challenges and uncertainties inherent in product research and
development, including the uncertainty of clinical success and of
obtaining regulatory approvals; uncertainty of commercial success;
manufacturing difficulties and delays; competition, including
technological advances, new products and patents attained by
competitors; challenges to patents; product efficacy or safety
concerns resulting in product recalls or regulatory action; changes
in behavior and spending patterns of purchasers of health care
products and services; changes to applicable laws and regulations,
including global health care reforms; and trends toward health care
cost containment. A further list and descriptions of these risks,
uncertainties and other factors can be found in Johnson &
Johnson's Annual Report on Form 10-K for the fiscal year ended
December 31, 2023, including in the
sections captioned "Cautionary Note Regarding Forward-Looking
Statements" and "Item 1A. Risk Factors," and in Johnson &
Johnson's subsequent Quarterly Reports on Form 10-Q and other
filings with the Securities and Exchange Commission. Copies of
these filings are available online at www.sec.gov, www.jnj.com or
on request from Johnson & Johnson. None of Janssen Research
& Development, LLC, Janssen Biotech, Inc. nor Johnson &
Johnson undertakes to update any forward-looking statement as a
result of new information or future events or developments.
Media contact:
Bridget Kimmel
Mobile: (215) 688-6033
bkimmel@its.jnj.com
Investor contact:
Raychel Kruper
investor-relations@its.jnj.com
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