- Additional data from Phase 3 ADAPT
trial demonstrate consistent depth of response across first two
treatment cycles as measured by minimal symptom expression
- Additional ADAPT data also show
consistent disease score improvements by patient subgroup based on
affected muscle domain or concomitant medication
- New analyses show efgartigimod
treatment does not impact vaccine immune response
- Initial data from MyRealWorld® MG
research study highlight severity of disease and treatment burden
of people living with gMG
Breda, the Netherlands –
October 8, 2021 – argenx
(Euronext & Nasdaq: ARGX), a global immunology company
committed to improving the lives of people suffering from severe
autoimmune diseases and cancers, today announced the presentation
of additional data from the Phase 3 ADAPT trial of efgartigimod for
the treatment of generalized myasthenia gravis (gMG). The data will
be presented at two upcoming neuromuscular meetings: the American
Association of Neuromuscular and Electrodiagnostic Medicine (AANEM)
Annual Meeting on October 13-16, 2021 in Aurora, CO and the virtual
Myasthenia Gravis Foundation of America Scientific Session (MGFA)
on October 30, 2021.
"The additional ADAPT data presented during
these important neuromuscular forums strengthen our understanding
of the value efgartigimod can offer as a potential treatment for
people living with gMG. Depth and consistency of disease score
improvement, as well as a patient's ability to mount a vaccine
response, are all key considerations for a treating physician,"
commented Wim Parys, M.D., Chief Medical Officer of argenx. "We are
also presenting the first data from our real-world evidence study,
through which we learn more about the severity of gMG and how it
can impair a person's ability to function and negatively impact
their quality of life. We will continue to listen to patients in
uncovering the real-world burden associated with management of this
debilitating, chronic disease."
AANEM Presentations
Title: “Examination of the
Efficacy, Safety, And Tolerability of Efgartigimod in Acetylcholine
Receptor Autoantibody Seronegative Patients with Generalized
Myasthenia Gravis: Subgroup Analysis of the Phase 3 ADAPT Study”
Winner, President Research Initiative
AwardPresenter: Chafic Karam, M.D.,
University of PennsylvaniaSession: Abstract Poster
Session I and IIDate and Time:
Thursday, October 14 from 1:00pm - 1:30pm MDT; 3:30pm - 4:00pm
MDTLocation: Poster Hall
Title: “Minimal Symptom
Expression in Patients with Generalized Myasthenia Gravis from
Treatment with Efgartigimod” Runner Up, Best
AbstractPresenter: Tuan Vu, M.D.,
University of South FloridaSession: Abstract
Poster Session I and IIDate and
Time: Thursday, October 14 from 1:00pm - 1:30pm
MDT; 3:30pm - 4:00pm MDTLocation: Poster Hall
Title: “Real-world
Patient-reported Impact of Myasthenia Gravis: Initial Data From the
MyRealWorld® MG Study” Author: Glenn Phillips,
Ph.D., Senior Director, Health Economics at
argenxSession: Abstract Poster Session III and IV
Date and Time: Friday, October 15
from 1:00pm - 1:30pm MDT; 3:30pm - 4:00pm
MDTLocation: Poster Hall
Title: “Patient Burden of
Generalized Myasthenia Gravis” Author: Suraj
Muley, M.D., Gregory W. Fulton ALS and Neuromuscular Center
Session: Abstract Poster
Session III and IVDate and Time:
Friday, October 15 from 1:00pm - 1:30pm MDT; 3:30pm - 4:00pm
MDTLocation: Poster Hall
Title: “Generalized Myasthenia
Gravis Management and Practice Guidelines: Cross-Sectional Survey
of Community Neurologists in the United States.”
Author: Gil Wolfe, M.D., University at Buffalo
Session: Abstract Poster Session III and
IVDate and Time: Friday, October 15 from 1:00pm -
1:30pm MDT; 3:30pm - 4:00pm MDTLocation: Poster
Hall
Title: “Diagnostic Adjudication
of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) In the
ADHERE Trial: Review of the First 100 Cases”
Author: Peter Donofrio, M.D., Vanderbilt
University Session: Abstract Poster Session III
and IVDate and Time: Friday,
October 15 from 1:00pm - 1:30pm MDT; 3:30pm - 4:00pm
MDTLocation: Poster Hall
In addition to the poster sessions listed above,
argenx will host a sponsored industry forum at AANEM:
Title: “Burden, Comorbidities,
and Treatment in Generalized Myasthenia Gravis: Where Do We
Stand?”Presenters: Nicholas J. Silvestri, M.D.,
FAAN, University at Buffalo; Neelam Goyal, M.D., Stanford Health
Care; John H. Stone, M.D., MPH, Massachusetts General
HospitalDate and
Time: Thursday, October 14 from 12:00 -
1:00pm MDTLocation: Juniper Ballroom
MGFA
Presentations
Title: “Real-world
Patient-reported Impact of Myasthenia Gravis: Initial Data From the
MyRealWorld MG Study”Author: Vera Bril, M.D.,
University Health Network, University of
TorontoTime: 12:00pm EDT
Title: “Efgartigimod Treatment
of Patients with Generalized Myasthenia Gravis Demonstrates
Consistent Improvements Across All Muscle Subgroups and Regardless
of Background Immunosuppressive Therapy” Author:
Chafic Karam, M.D., University of Pennsylvania
Time: 2:20pm EDT
Title: “Effect of Efgartigimod,
A Neonatal Fc Receptor Blocker, on Humoral Vaccine Responses in
Autoimmune Patients” Author: Jeffrey Guptill,
M.D., MA, MHS, Duke University Time: 2:35pm
EDT
Posters
Title: “Real World IVIG Usage
in U.S. Adults With Generalized Myasthenia Gravis"
Author: Glenn Phillips, Ph.D., Senior Director,
Health Economics at argenx
About MGMG is a rare and
chronic autoimmune disease where IgG antibodies disrupt
communication between nerves and muscles, causing debilitating and
potentially life-threatening muscle weakness. More than 85% of
people with MG progress to generalized MG (gMG) within 18 months,
where muscles throughout the body may be affected, resulting in
extreme fatigue and difficulties with facial expression, speech,
swallowing and mobility. In more life-threatening cases, MG can
affect the muscles responsible for breathing. Patients with
confirmed AChR antibodies account for 80-90% of the total gMG
population. There are approximately 65,000 people in the United
States and 20,000 people in Japan living with the disease.
About CIDPChronic inflammatory
demyelinating polyneuropathy (CIDP) is a rare and serious
autoimmune disease of the peripheral nervous system. Although
confirmation of disease pathophysiology is still emerging, there is
increasing evidence that IgG antibodies play a key role in the
damage to the peripheral nerves. People with CIDP experience
fatigue, muscle weakness and a loss of feeling in their arms and
legs that can get worse over time or may come and go. These
symptoms can significantly impair a person's ability to function in
their daily lives. Without treatment, one-third of people living
with CIDP will need a wheelchair.
About Efgartigimod Efgartigimod
is an investigational antibody fragment designed to reduce
pathogenic immunoglobulin G (IgG) antibodies by binding to the
neonatal Fc receptor and blocking the IgG recycling process.
Efgartigimod is being investigated in several autoimmune diseases
known to be mediated by disease-causing IgG antibodies, including
neuromuscular disorders, blood disorders, and skin blistering
diseases.
About argenx argenx is a global
immunology company committed to improving the lives of people
suffering from severe autoimmune diseases and cancer. Partnering
with leading academic researchers through its Immunology Innovation
Program (IIP), argenx aims to translate immunology breakthroughs
into a world-class portfolio of novel antibody-based medicines.
argenx is evaluating efgartigimod in multiple serious autoimmune
diseases. argenx is also advancing several earlier stage
experimental medicines within its therapeutic franchises. argenx
has offices in Belgium, the United States, Japan, and Switzerland.
For more information, visit www.argenx.com and follow us
on LinkedIn.
Media:Kelsey
Kirkkkirk@argenx.com
Joke Comijnjcomijn@argenx.com
Investors:Beth
DelGiaccobdelgiacco@argenx.com
Michelle
Greenblattmgreenblatt@argenx.com
Forward Looking Statements
The contents of this announcement include
statements that are, or may be deemed to be, forward-looking
statements. These forward-looking statements can be identified by
the use of forward-looking terminology, including the terms
believes, estimates, anticipates, expects, intends, may, will, or
should and include statements argenx makes concerning the clinical
data of its product candidates; the intended results of its
strategy; the momentum of its product candidate pipeline as well as
argenx’s statements regarding research advancements and number of
treatment options; and its plans to partner with advocacy
organizations. By their nature, forward-looking statements involve
risks and uncertainties and readers are cautioned that any such
forward-looking statements are not guarantees of future
performance. argenx’s actual results may differ materially from
those predicted by the forward-looking statements as a result of
various important factors, including argenx’s expectations
regarding its the inherent uncertainties associated with
competitive developments, preclinical and clinical trial and
product development activities and regulatory approval
requirements; argenx’s reliance on collaborations with third
parties; estimating the commercial potential of argenx’s product
candidates; argenx’s ability to obtain and maintain protection of
intellectual property for its technologies and drugs; argenx’s
limited operating history; and argenx’s ability to obtain
additional funding for operations and to complete the development
and commercialization of its product candidates. A further list and
description of these risks, uncertainties and other risks can be
found in argenx’s U.S. Securities and Exchange Commission (SEC)
filings and reports, including in argenx’s most recent annual
report on Form 20-F filed with the SEC as well as subsequent
filings and reports filed by argenx with the SEC. Given these
uncertainties, the reader is advised not to place any undue
reliance on such forward-looking statements. These forward-looking
statements speak only as of the date of publication of this
document. argenx undertakes no obligation to publicly update or
revise the information in this press release, including any
forward-looking statements, except as may be required by law.
# # #
- argenx Press Release-AANEM 2021 Curtain Raiser FINAL
Argen X (EU:ARGX)
Graphique Historique de l'Action
De Fév 2024 à Mar 2024
Argen X (EU:ARGX)
Graphique Historique de l'Action
De Mar 2023 à Mar 2024