argenx to present complete data from the Phase 2 proof-of-concept trial of efgartigimod (ARGX-113) in generalized myasthenia ...
April 24 2018 - 1:01AM
- 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 DesignThe 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 efgartigimodEfgartigimod (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 argenxargenx 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 19info@argenx.com
Beth DelGiacco (US IR)Stern Investor Relations+1 212 362
1200beth@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.
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