argenx to present complete data from the Phase 2 proof-of-concept trial of efgartigimod (ARGX-113) in generalized myasthenia ...
April 24 2018 - 1:00AM
-
Eight-week follow-up data show separation of
clinical efficacy scores between treatment group and placebo group
through the duration of study
-
Total and pathogenic IgG reduction correlates
with disease score improvements
Company to host workshop and webcast today at 1:00
p.m. PT
April 24,
2018
Breda, the
Netherlands / Ghent, Belgium - argenx (Euronext & Nasdaq:
ARGX), a clinical-stage biotechnology company developing a deep
pipeline of differentiated antibody-based therapies for the
treatment of severe autoimmune diseases and cancer, today announced
that it will present complete data from the Phase 2
proof-of-concept trial of efgartigimod (ARGX-113) in generalized
myasthenia gravis (MG) patients at the 2018 American Academy of
Neurology (AAN) Annual Meeting in Los Angeles, CA. These data will
be presented during the Clinical Trial Plenary Session by James F.
Howard Jr., M.D., principal investigator on the trial and
Distinguished Professor of Neuromuscular Disease, Professor of
Neurology, Medicine & Allied Health, and Chief, Neuromuscular
Disorders Section, The University of North Carolina School of
Medicine.
"We are very encouraged by the
full set of data on efgartigimod that will be presented today at
AAN, particularly the correlation of total and pathogenic IgG
reduction and clinical response. The data show an early separation
between treatment and placebo groups on efficacy scores that
persisted for the total duration of the study. We believe this may
be as a differentiator from current therapies for managing IgG
levels, including plasmapheresis, where benefit reversed more
rapidly," commented Nicolas Leupin, CMO of argenx. "We continue to
learn more about the novel mechanism of action of our drug
candidate and look forward to reporting data from two additional
indications this year, immune thrombocytopenia and pemphigus
vulgaris, which like MG, are diseases mediated by pathogenic
IgGs."
The tolerability of efgartigimod
remained consistent with findings from the Phase 1 trial in healthy
volunteers. The study drug candidate was well-tolerated in all
patients with no serious or severe adverse events reported, and
most adverse events were characterized as mild and deemed unrelated
to the drug candidate.
Key Highlights
from Full Phase 2 Dataset
-
Full efficacy data through the eight-week
follow-up phase show that administration of efgartigimod resulted
in clinical improvement over the placebo through the entire
duration of study (11 weeks). Clinical benefit in the
efgartigimod treatment group maximized as of one week after the
administration of the last dose, achieving statistical significance
over the placebo group (p = 0.0356) on the Myasthenia Gravis
Activity-of-Daily-Living (MG-ADL) score.
-
75% of patients treated with efgartigimod had a
clinically meaningful and statistically significant improvement in
MG-ADL scores (at least a two-point reduction from baseline) for a
period of at least six consecutive weeks, versus 25% of patients on
the placebo (p = 0.0391).
-
Increasing differentiation was observed between
the efgartigimod treatment group versus the placebo group, with
increasing MG-ADL thresholds. Updated results will include the
differentiation between the treatment and placebo groups for both
the MG-ADL and Quantitative Myasthenia Gravis (QMG) thresholds at
the 29-day point and the 36-day point.
-
Patients in the treatment arm showed disease
improvement, with separation from the patients in the placebo group
one week after the first infusion that persisted after the last
dose.
-
Efgartigimod treatment resulted in clinical
improvement over the placebo, as measured by all four predefined
clinical efficacy scales - MG-ADL, QMG, Myasthenia Gravis Composite
(MGC) and Myasthenia Gravis Quality of Life (MG-QoL).
-
All patients in the treatment arm showed a
reduction of total IgG levels. Clinically meaningful disease
improvement was found to correlate with reduction in pathogenic IgG
levels.
-
Total IgG reduction in patients was consistent
with the Phase 1 healthy volunteer trial.
-
Reduction of IgG levels was consistent across
IgG subtypes, including AChR autoantibodies (IgG1 and IgG3).
-
Updated results show mean maximum IgG reduction
of up to 70.7% among treated patients.
argenx is conducting two
additional ongoing Phase 2 clinical trials of efgartigimod in
immune thrombocytopenia (ITP) and pemphigus vulgaris (PV). Topline
data from the ITP trial and interim data from the PV trial are both
expected in the second half of 2018.
An investor workshop is being held
today at 1:00 p.m. PT in Los Angeles to discuss the complete
efgartigimod clinical data presented by Dr. Howard. A live webcast
of the presentation will be available on the Company's website
www.argenx.com or by clicking here. A replay of the webcast will be
available for 90 days following the presentation.
Phase 2 Trial
Design
The Phase 2 trial evaluated 24 MG patients with generalized muscle
weakness, and a total MG-ADL score >=5, with more than 50% of
the score consisting of non-ocular items. Patients were randomized
to receive four weekly doses of either standard of care plus 10
mg/kg of ARGX-113, or standard of care plus placebo. Standard of
care therapies included acetylcholinesterase inhibitors,
corticosteroids and/or immunomodulatory agents. The primary
endpoints of the trial were safety and tolerability. Secondary
endpoints included efficacy as measured by the change from baseline
of the MG-ADL, QMG, and MGC disease severity scores; impact on
quality of life as measured by the MGQoL score; and an assessment
of pharmacokinetics (PK) and pharmacodynamic (PD) markers and
immunogenicity.
About
efgartigimod
Efgartigimod (ARGX-113) is an investigational therapy for
IgG-mediated autoimmune diseases and was designed to exploit the
natural interaction between IgG antibodies and the recycling
receptor FcRn. ARGX-113 is the Fc-portion of an antibody that has
been modified by the argenx proprietary ABDEG(TM) technology to
increase its affinity for FcRn beyond that of normal IgG
antibodies. As a result, ARGX-113 blocks antibody recycling through
FcRn binding and leads to fast depletion of the autoimmune
disease-causing IgG autoantibodies. The development work on
ARGX-113 is done in close collaboration with Prof. E. Sally Ward
(University of Texas Southwestern Medical and Texas A&M
University Health Science Center, a part of Texas A&M
University (TAMHSC)).
About
argenx
argenx is a clinical-stage biotechnology company developing a deep
pipeline of differentiated antibody-based therapies for the
treatment of severe auto-immune diseases and cancer. We are focused
on developing product candidates with the potential to be either
first-in-class against novel targets or best-in-class against
known, but complex, targets in order to treat diseases with a
significant unmet medical need. Our ability to execute on this
focus is enabled by our suite of differentiated technologies. Our
SIMPLE AntibodyTM Platform,
based on the powerful llama immune system, allows us to exploit
novel and complex targets, and our three antibody engineering
technologies are designed to enable us to expand the therapeutic
index of our product candidates.
www.argenx.com
For further information, please
contact:
Joke Comijn, Corporate Communications & IR
Manager
+32 (0)477 77 29 44
+32 (0)9 310 34 19
info@argenx.com
Beth DelGiacco (US IR)
Stern Investor Relations
+1 212 362 1200
beth@sternir.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 intended results of its
strategy and argenx's advancement of, and anticipated clinical
development and regulatory milestones and plans, including the
timing of expected data readouts, related to ARGX-113. 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.
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: argenx SE via Globenewswire
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