-
Study met primary endpoint (p=0.000039); VYVGART® Hytrulo
demonstrated 61% reduction (HR: 0.39 95% CI: 0.25; 0.61) in risk of
relapse versus placebo
-
IgG autoantibodies shown to play significant role in underlying
CIDP disease biology
-
Favorable safety and tolerability profile consistent with previous
clinical trials and confirmed safety profile of VYVGART®
-
Conference call scheduled for today, July 17, 2023 at 8:30am ET
(2:30pm CET)
Regulated information – Inside
information
Amsterdam, The Netherlands –
July 17, 2023 –
argenx SE (Euronext & Nasdaq: ARGX), a global immunology
company committed to improving the lives of people suffering from
severe autoimmune diseases, today announced positive topline
results from the ADHERE study evaluating VYVGART Hytrulo
(efgartigimod alfa and hyaluronidase-qvfc) in adults with chronic
inflammatory demyelinating polyneuropathy (CIDP). The study met its
primary endpoint (p=0.000039), demonstrating a significantly lower
risk of relapse with VYVGART Hytrulo compared to placebo. Detailed
data from ADHERE will be presented at an upcoming medical
meeting.
ADHERE Highlights
- Primary endpoint met (p=0.000039);
VYVGART Hytrulo demonstrated 61% reduction (HR: 0.39 95% CI: 0.25;
0.61) in the risk of relapse versus placebo
- 67% of patients in open-label Stage
A demonstrated evidence of clinical improvement (ECI), indicating
that IgG autoantibodies play a significant role in the underlying
biology of CIDP
- Safety and tolerability profile
consistent with confirmed safety profile of VYVGART
- 91% (226/249) of eligible patients
continued to the ADHERE-Plus open-label extension study
"CIDP is a chronic, progressive autoimmune disease that can
cause substantial disability in those affected, often leading to
impaired ambulation or difficulty completing normal daily tasks
without help. The positive ADHERE data show that VYVGART Hytrulo
may represent a new patient-forward treatment option that can
prevent symptom deterioration while minimizing side effects and
treatment burden,” commented Jeffrey Allen, M.D., Associate
Professor, Department of Neurology, University of Minnesota. “With
ADHERE, argenx has set a new standard for innovative CIDP studies
that more broadly inform the neuromuscular community. The findings
from the trial indicate we may have a novel weapon to combat this
debilitating condition in our ongoing efforts to improve the lives
of individuals affected by CIDP.”
“People living with CIDP often experience
significant challenges with daily function including fatigue,
numbness, tingling, pain and weakness while facing a future with
limited mobility or independence. The promising ADHERE data bring
hope to the CIDP community of a brighter future where they could
experience more positive moments doing the things that make them
most happy,” said Lisa Butler, Executive Director of the GBS-CIDP
Foundation International.
“With these positive ADHERE data, we have
generated strong clinical evidence that CIDP has a significant
IgG-driven pathogenesis component and that VYVGART Hytrulo can
meaningfully improve and stabilize disease symptoms with a
favorable safety profile and a simple route of administration,”
commented Luc Truyen, M.D., Ph.D., Chief Medical Officer of argenx.
“We are very grateful to the patients participating in the ADHERE
trial and their supporters, the investigators, our collaborators
and our argenx colleagues for the success of this innovative trial.
Together, we are moving one step closer to transforming the
treatment of autoimmunity.”
Detailed ADHERE Results
ADHERE is the largest clinical trial of CIDP
patients to date, enrolling adults who were treatment naïve (not on
active treatment within the past six months) or currently on
immunoglobulin therapy or corticosteroids. The trial consisted of a
run-in period where current treatment was stopped followed by an
open-label Stage A, after which responders to VYVGART Hytrulo
advanced to a randomized, placebo-controlled Stage B.
322 patients enrolled in Stage A and received
treatment with VYVGART Hytrulo
- 67% (214/322) demonstrated evidence
of clinical improvement (ECI) after a run-in withdrawal period
based on the Inflammatory Neuropathy Cause and Treatment (INCAT)
Disability Score, the Inflammatory Rasch-built Overall Disability
Scale (I-RODS) or grip strength
- 70% (214/304) demonstrated ECI
excluding patients ongoing in Stage A at the time of the 88th event
who did not have the full opportunity to achieve a response
- 78% (214/275) demonstrated ECI in a
sensitivity analysis of patients who received at least four
injections to reach the full IgG-lowering effect of VYVGART
Hytrulo
- Response rates similar across all
prior CIDP medication subgroups with consistent efficacy on INCAT,
I-RODS and grip strength.
221 responders from Stage A entered Stage B,
where the primary endpoint was the relative risk of relapse based
on time to relapse on the INCAT Disability Score
- VYVGART Hytrulo significantly
reduced the risk of CIDP relapse compared to placebo
- Primary endpoint was met
(p=0.000039); VYVGART Hytrulo demonstrated a 61% reduction (HR:
0.39 95% CI: 0.25; 0.61) in the risk of relapse compared to placebo
based on time to the first adjusted INCAT deterioration of ≥1
point
- VYVGART Hytrulo patients had a
lower relapse rate compared to placebo at Week 24 (26% versus 54%)
and Week 48 (34% versus 60%)
- VYVGART Hytrulo patients
experienced longer time to relapse compared to those on placebo
with a rapid separation of the Kaplan–Meier curves beginning at
Week 4 and sustained through Week 48
- VYVGART Hytrulo patients
demonstrated a clinically meaningful mean improvement of 7.7 points
on I-RODS and 12.3kPa on grip strength in Stage A. This clinically
meaningful benefit was maintained in Stage B by treated patients
and lost in placebo patients.
- Clinical benefit observed across
all efficacy scales and patient subgroups, regardless of prior
therapy
VYVGART Hytrulo was well-tolerated with a safety
profile that is consistent with prior clinical trials and the known
profile of VYVGART. The most frequent treatment-related adverse
event was injection site reactions (ISRs), which occurred in a
lower percentage of patients than previous VYVGART Hytrulo trials
(20% in Stage A; 10% in Stage B). All ISRs were mild to moderate
and resolved over time.
Conference Call Detailsargenx
will host a conference call today at 2:30pm CET (8:30am ET) to
discuss the ADHERE results. A webcast of the live call and replay
may be accessed on the Investors section of the argenx website.
Dial-in
Numbers:Please
dial in 15 minutes prior to the live call.
Belgium 32
800 50
201France 33
800
943355Netherlands 31
20 795 1090United
Kingdom 44 800 358
0970United States
1
888 415
4250Japan 81
3 4578
9081Switzerland 41
43 210 11 32
About ADHERE Trial Design The
ADHERE trial was a multicenter, randomized, double-blind,
placebo-controlled trial evaluating VYVGART® Hytrulo (efgartigimod
alfa and hyaluronidase-qvfc) for the treatment of chronic
inflammatory demyelinating polyneuropathy (CIDP). ADHERE enrolled
322 adult patients with CIDP who were treatment naïve (not on
active treatment within the past six months or newly diagnosed) or
being treated with immunoglobulin therapy or corticosteroids. The
trial consisted of an open-label Stage A followed by a randomized,
placebo-controlled Stage B. In order to be eligible for the trial,
the diagnosis of CIDP was confirmed by an independent panel of
experts. Patients entered a run-in stage, where any ongoing CIDP
treatment was stopped and in order to be eligible for Stage A had
to demonstrate active disease, with clinically meaningful worsening
on at least one CIDP clinical assessment tool, including INCAT,
I-RODS, or mean grip strength. Treatment naïve patients were able
to skip the run-in period with proof of recent worsening. To
advance to Stage B, patients needed to demonstrate evidence of
clinical improvement (ECI) with VYVGART Hytrulo. ECI was achieved
through improvement of the INCAT score, or improvement on I-RODS or
mean grip strength if those scales had demonstrated worsening
during the run-in period. In Stage B, patients were randomized to
either VYVGART Hytrulo or placebo for up to 48 weeks. The primary
endpoint was measured once 88 total relapses or events were
achieved in Stage B and was based on the hazard ratio for the time
to first adjusted INCAT deterioration (i.e. relapse). After Stage
B, all patients had the option to roll-over to an open-label
extension study to receive VYVGART Hytrulo.
argenx has an exclusive license agreement with
Zai Lab for the development and commercialization of VYVGART and
VYVGART Hytrulo in Greater China. Through this agreement, Zai Lab
recruited Chinese patients into the ADHERE trial.
About Chronic
Inflammatory Demyelinating PolyneuropathyChronic
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 VYVGART®
Hytrulo
VYVGART Hytrulo is a subcutaneous combination of
efgartigimod alfa, a human IgG1 antibody fragment marketed for
intravenous use as VYVGART®, and recombinant human hyaluronidase
PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to
facilitate subcutaneous injection delivery of biologics. In binding
to the neonatal Fc receptor (FcRn), VYVGART Hytrulo results in the
reduction of circulating IgG. It is the first-and-only approved
FcRn blocker administered by subcutaneous injection.
VYVGART Hytrulo is the proprietary name in the
U.S. for subcutaneous efgartigimod alfa and recombinant human
hyaluronidase PH20. It may be marketed under different proprietary
names following approval in other regions.
See Important Safety Information below and full
Prescribing Information for VYVGART Hytrulo for additional
information
Important Safety
Information
What is VYVGART® HYTRULO (efgartigimod
alfa and
hyaluronidase-qvfc)?VYVGART
HYTRULO is a prescription medicine used to treat a condition called
generalized myasthenia gravis, which causes muscles to tire and
weaken easily throughout the body, in adults who are positive for
antibodies directed toward a protein called acetylcholine receptor
(anti-AChR antibody positive).
IMPORTANT SAFETY
INFORMATION
What is the most important information I
should know about VYVGART HYTRULO?VYVGART HYTRULO may
cause serious side effects, including:
- Infection. VYVGART
HYTRULO may increase the risk of infection. The most common
infections for efgartigimod alfa-fcab-treated patients were urinary
tract and respiratory tract infections. More patients on
efgartigimod alfa-fcab vs placebo had below normal levels for white
blood cell counts, lymphocyte counts, and neutrophil counts. The
majority of infections and observed lower white blood cell counts
were mild to moderate in severity. Your healthcare provider should
check you for infections before starting treatment, during
treatment, and after treatment with VYVGART HYTRULO. Tell your
healthcare provider if you have any history of infections. Tell
your healthcare provider right away if you have signs or symptoms
of an infection during treatment with VYVGART HYTRULO such as
fever, chills, frequent and/or painful urination, cough, pain and
blockage of nasal passages/sinus, wheezing, shortness of breath,
fatigue, sore throat, excess phlegm, nasal discharge, back pain,
and/or chest pain. If a serious infection occurs, your doctor will
treat your infection and may even stop your VYVGART HYTRULO
treatment until the infection has resolved.
- Undesirable immune
reactions (hypersensitivity reactions). VYVGART HYTRULO
and efgartigimod alfa-fcab can cause the immune system to have
undesirable reactions such as rashes, swelling under the skin, and
shortness of breath. Hives were also observed in patients treated
with VYVGART HYTRULO. In clinical studies, the reactions were mild
or moderate and occurred within 1 hour to 3 weeks of
administration, and the reactions did not lead to VYVGART HYTRULO
discontinuation. Your healthcare provider should monitor you during
and after treatment and discontinue VYVGART HYTRULO if needed. Tell
your healthcare provider immediately about any undesirable
reactions to VYVGART HYTRULO.
Before taking VYVGART HYTRULO, tell your
healthcare provider about all of your medical conditions, including
if you:
- Have a history of infection or you
think you have an infection.
- Have received or are scheduled to
receive a vaccine (immunization). Discuss with your healthcare
provider whether you need to receive age-appropriate immunizations
before initiation of a new treatment cycle with VYVGART HYTRULO.
The use of vaccines during VYVGART HYTRULO treatment has not been
studied, and the safety with live or live-attenuated vaccines is
unknown. Administration of live or live-attenuated vaccines is not
recommended during treatment with VYVGART HYTRULO.
- Are pregnant or plan to become
pregnant and are breastfeeding or plan to breastfeed.
Tell your healthcare provider about all the
medicines you take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements.
What are the common side effects of
VYVGART HYTRULO?The most common side effects of
efgartigimod alfa-fcab-treated patients were respiratory tract
infection, headache, and urinary tract infection. Additional common
side effects of VYVGART HYTRULO are injection site reactions,
including rash, redness of the skin, itching sensation, bruising,
pain, and hives.These are not all the possible side effects of
VYVGART HYTRULO. Call your doctor for medical advice about side
effects. You may report side effects to the US Food and Drug
Administration at 1-800-FDA-1088.
Please see the full Prescribing
Information for VYVGART HYTRULO and talk to your
doctor.
About argenx argenx is a global
immunology company committed to improving the lives of people
suffering from severe autoimmune diseases. 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
developed and is commercializing the first approved neonatal Fc
receptor (FcRn) blocker in the U.S., Japan, Israel, the EU, the UK
and China. The Company is evaluating efgartigimod in multiple
serious autoimmune diseases and advancing several earlier stage
experimental medicines within its therapeutic franchises. For more
information, visit www.argenx.com and follow us on LinkedIn,
Twitter, and Instagram.
For further information, please contact:
Media:Erin Murphyemurphy@argenx.com
Investors:Alexandra Roy (US)ARoy@argenx.com
Lynn Elton (EU)LElton@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 “may,”
“will,” or “should” and include those that argenx makes concerning
the benefits and safety profile of VYVGART and VYVGART Hytrulo; the
expected availability of VYVGART Hytrulo; the safety profile and
efficacy signals from the ADHERE study; and the prospects of
VYVGART Hytrulo as a treatment for chronic inflammatory
demyelinating polyneuropathy (“CIDP”), including its ability to
transform CIDP treatment for patients and the therapeutic potential
and patient treatment experience of VYVGART Hytrulo for the
treatment of CIDP. 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. 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 press release. 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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