argenx Announces “GO” Decision in ADHERE Trial of Efgartigimod in Chronic Inflammatory Demyelinating Polyneuropathy Follo...
01 Fevereiro 2021 - 03:00AM
Regulated Information/Inside
Information
-
Independent data monitoring committee confirmed go-forward decision
based on evaluation of interim safety as well as efficacy
assessments that surpassed pre-defined “GO” threshold
- 130
patients targeted for enrollment to support registrational program
in CIDP
-
Management to host conference call today at 2:30 p.m. CET (8:30
a.m. ET)
February 1, 2021 Breda,
the Netherlands – argenx SE (Euronext & Nasdaq: ARGX),
a global immunology company committed to improving the lives of
people suffering from severe autoimmune diseases and cancer, today
announced its plan to continue enrollment in the ADHERE trial
evaluating subcutaneous (SC) efgartigimod (co-formulated with
Halozyme's ENHANZE® drug-delivery technology) in chronic
inflammatory demyelinating polyneuropathy (CIDP). The ADHERE trial
is expected to enroll approximately 130 patients to support
potential registration of SC efgartigimod for the treatment of
CIDP.
“Following our review of the interim ADHERE data
and confirmation from the data monitoring committee, we are
confident in our decision to continue with enrollment. We relied on
key learnings from precedent CIDP trials in defining our go-forward
thresholds and are excited to have cleared this first hurdle on the
path to registration of efgartigimod in CIDP,” commented Wim Parys,
M.D., Chief Medical Officer of argenx. “CIDP is now the fourth
autoimmune disease that we selected based on its solid biological
rationale where we have demonstrated clinical proof-of-concept,
further emphasizing the broad applicability of efgartigimod. We
hope to be able to offer a new potential treatment to CIDP patients
who have limited therapeutic options for this severe, progressive
disease.”
The “GO” decision was based on a planned
efficacy and safety assessment following the enrollment of 30
patients into the initial part of the ADHERE trial. The interim
analysis achieved the pre-defined threshold for continuation, which
was based on response rates seen in precedent clinical trials of
current standard of care in CIDP. The decision to continue
enrollment was confirmed by an independent data monitoring
committee. In addition, the tolerability profile observed to date
is consistent with that of efgartigimod in other clinical
trials.
The company will host a conference call today at
2:30 p.m. CET (8:30 a.m. ET) to discuss the decision to continue
enrollment in ADHERE.
Dial-in numbers: Please
dial in 15 minutes prior to the live call.
Belgium |
0800 389
13 |
France |
0805 102
319 |
Netherlands |
0800 949
4506 |
United
Kingdom |
0800 279
9489 |
United
States |
1 844 808
7140 |
International |
1 412 902
0128 |
A live webcast of the presentation will be
available on the Company’s website at www.argenx.com. A replay of
the webcast will be available for approximately 1 year following
the presentation.
ADHERE Trial Design
The ADHERE trial is a randomized, withdrawal
study evaluating 1000mg weekly subcutaneous (SC) efgartigimod for
the treatment of chronic inflammatory demyelinating polyneuropathy
(CIDP). The trial consists of an open-label Stage A followed by a
randomized, placebo-controlled Stage B with a planned interim
responder analysis after the first 30 patients enroll in Stage A.
In order to enter Stage A and receive efgartigimod, both patients
who were treatment-naïve or on therapy must first receive a
confirmed diagnosis of CIDP by an independent panel of experts and
demonstrate active disease. To show active disease, patients who
are on current CIDP therapy have to demonstrate a minimal
clinically meaningful worsening after treatment withdrawal based on
at least one CIDP clinical assessment tool, including INCAT, iRODS,
or mean grip strength. To advance to Stage B, patients need to
demonstrate a minimal clinically meaningful response to
efgartigimod equivalent with the loss observed on the same efficacy
scale on which worsening is observed during the withdrawal period.
In Stage B, patients are randomized to either SC efgartigimod or
placebo for up to 48 weeks. The primary endpoint is event-driven
and based on the adjusted INCAT efficacy score in Stage B.
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 CIDP
Chronic 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 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 more information, visit www.argenx.com and
follow us on LinkedIn.
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 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
preliminary analysis of the ADHERE trial and its plans to
continue enrollment of the ADHERE trial; the therapeutic potential
of its product candidates; the intended results of its strategy;
including the timing, design and outcome of the ADHERE clinical
trial. 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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