argenx Issues Statement Concerning Efgartigimod
02 Fevereiro 2021 - 11:37AM
-No observed
elevation of cholesterol markers related to treatment with
efgartigimod
February 2, 2021 Breda,
the Netherlands – argenx SE (Euronext & Nasdaq: ARGX),
today provided a statement in response to news from Immunovant
regarding a voluntary pause of dosing in its ongoing trials for
IMVT-1401, an FcRn antagonist. Today’s announcement by Immunovant
was issued following an observed signal of elevated total
cholesterol and LDL levels in one of its ongoing trials.
argenx has evaluated efgartigimod in over 350 subjects and
patients, and is not aware of any elevation of cholesterol markers
related to treatment with efgartigimod.
Total cholesterol, HDL and LDL were measured in at least 117
subjects in multiple Phase 1 healthy volunteer trials and there
were no observed increases from baseline measurements over time.
Additionally, total cholesterol, HDL and LDL were measured in 167
patients throughout the 26-week placebo-controlled Phase 3 ADAPT
trial and efgartigimod was observed to have a comparable profile to
placebo.
About Efgartigimod
Efgartigimod is an investigational antibody
fragment designed to reduce disease-causing immunoglobulin G (IgG)
antibodies and block the IgG recycling process. Efgartigimod binds
to the neonatal Fc receptor (FcRn), which is widely expressed
throughout the body and plays a central role in rescuing IgG
antibodies from degradation. Blocking FcRn reduces IgG antibody
levels representing a logical potential therapeutic approach for
several autoimmune diseases known to be driven by disease-causing
IgG antibodies, including: myasthenia gravis (MG), a chronic
disease that causes muscle weakness; pemphigus vulgaris (PV), a
chronic disease characterized by severe blistering of the skin;
immune thrombocytopenia (ITP), a chronic bruising and bleeding
disease; and chronic inflammatory demyelinating polyneuropathy
(CIDP), a neurological disease leading to impaired motor function.
The subcutaneous formulation of efgartigimod is co-formulated with
Halozyme’s ENHANZE® drug delivery technology and is administered as
a 1000mg weekly single injection.
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, and cusatuzumab in
hematological cancers in collaboration with Janssen. argenx is also
advancing several earlier stage experimental medicines within its
therapeutic franchises. argenx has offices in Belgium, the United
States, and Japan.
For further information, please
contact:
Media:Kelsey KirkKKirk@argenx.com
Investors:Beth DelGiacco
bdelgiacco@argenx.com
Joke Comijn (EU)jcomijn@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 include statements
concerning the lack of elevated cholesterol markers in patients
related with efgartigimod. 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 the
effects of the COVID-19 pandemic, the inherent uncertainties
associated with 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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