- Study
did not meet primary or secondary endpoints
-
Favorable safety and tolerability profile consistent with previous
clinical trials
-
Conference call scheduled for today, November 28, 2023 at 8:30am ET
(2:30pm CET)
Regulated
information – Inside information
November 28, 2023, 7:00am
CET
Amsterdam, the Netherlands –
argenx SE (Euronext & Nasdaq: ARGX), a global immunology
company committed to improving the lives of people suffering from
severe autoimmune diseases, today announced topline results from
the ADVANCE-SC study evaluating VYVGART Hytrulo (efgartigimod alfa
and hyaluronidase-qvfc) in adults with primary immune
thrombocytopenia (ITP). The study did not meet the primary endpoint
of a sustained platelet count response in chronic ITP patients.
Additional analyses of the dataset are ongoing
and the full results will be presented at an upcoming medical
meeting and in a peer-reviewed publication.
“This is not the outcome we had hoped for
patients, but setbacks are part of pioneering a new class of
medicines and these data will provide insights into the broader
understanding of FcRn and ITP,” said Luc Truyen, M.D., Ph.D., Chief
Medical Officer of argenx. “We are very grateful to everyone
involved in the ADVANCE-SC study, especially the patients and their
families, the investigators, and our internal team who worked
tirelessly to complete this global study. We remain committed to
the ITP patient community who urgently needs additional treatment
options to manage this challenging disease, and continue to move
forward in our deeper analysis of these results.“
ADVANCE-SC Study Data
ADVANCE-SC is the second of two registrational
trials conducted as part of the ongoing ITP development program for
VYVGART and enrolled 207 adult patients with chronic and persistent
ITP. Patients were heavily pre-treated and 75% of patients had
received three or more prior ITP therapies.
- Primary endpoint was not met
(p=0.5081); 13.7% (17/124) of treated patients demonstrated a
sustained platelet count response compared to 16.2% (11/68) of
placebo patients
- Secondary endpoints were not met,
including additional endpoints on International Working Group (IWG)
responder status and mean platelet count change from baseline
- VYVGART Hytrulo was well-tolerated
in ADVANCE-SC; the observed safety and tolerability profile was
consistent with ADVANCE-IV and the confirmed safety profile of
VYVGART and VYVGART Hytrulo
Results from the first study in the ITP
registrational program, ADVANCE-IV, were reported in May 2022. The
study met its primary and key platelet-derived secondary endpoints.
ADVANCE-IV formed the basis of the regulatory submission for
approval of VYVGART IV for ITP in Japan, where a decision is
expected in the first quarter of 2024.
VYVGART is currently being evaluated in 13
severe autoimmune diseases, including the registrational ADDRESS
study for pemphigus from which topline results are expected around
year-end 2023.
Conference Call Detailsargenx
will host a conference call today at 2:30 pm CET (8:30am ET) to
discuss the ADVANCE-SC 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 the ADVANCE-SC Study
The ADVANCE-SC trial was a randomized,
double-blind, placebo-controlled, multicenter, global trial
evaluating the efficacy and safety of VYVGART Hytrulo (efgartigimod
alfa and hyaluronidase-qvfc) in adult patients with chronic or
persistent primary ITP. Enrolled patients had a confirmed ITP
diagnosis and a mean entry platelet count of less than 30x109/L.
Patients were on a stable dose of at least one ITP treatment prior
to randomization and had received at least one prior therapy.
Concomitant medications permitted included corticosteroids,
nonsteroidal immunosuppressive drugs, fostamatinib or TPO-RAs. The
study patients who were on 'watch and wait' at baseline were
required to have received at least 2 prior treatments for ITP.
Patients were randomized in a 2:1 ratio to
receive VYVGART Hytrulo or placebo for a total of 24 weeks as part
of the primary trial. The primary endpoint was measured by the
proportion of patients with chronic ITP with a sustained platelet
count response defined as achieving platelet counts of greater than
or equal to 50x109/L for at least four of the last six scheduled
visits between weeks 19 and 24. Patients who received rescue
therapy at week 12 or later, or for whom dose and/or frequency of
concurrent ITP therapies increased at week 12 or later, were
considered non-responders. Key secondary endpoints included extent
of disease control over 24-week treatment period, proportion of
overall population with sustained platelet count response, an
extended primary endpoint analysis between weeks 17 and 24, and the
incidence and severity of WHO-classified bleeding events.
About Immune Thrombocytopenia
(ITP)
Immune thrombocytopenia (ITP) is an autoimmune
disorder where immunoglobulin G (IgG) autoantibodies destroy
platelets and reduce platelet production, which can lead to an
increased risk of excessive bleeding and bruising. In rare cases,
ITP can lead to severe anemia and life threatening gastrointestinal
or intracranial hemorrhages. ITP is also associated with
debilitating fatigue and significant impacts on mental health,
including anxiety, fear and depression. Many ITP patients are
inadequately controlled on current therapies so a significant unmet
need exists for additional treatment options.
About VYVGART HytruloVYVGART
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.
VYVGART Hytrulo is the proprietary name in the
U.S. for subcutaneous efgartigimod alfa and recombinant human
hyaluronidase PH20. It is marketed in Europe as VYVGART and may be
marketed under different proprietary names following approval in
other regions.
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, China and Canada. 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:Ben
Petokbpetok@argenx.com
Investors:Alexandra Roy
(US)aroy@argenx.com
Lynn Elton (EU)lelton@argenx.com
This press release contains inside information
within the meaning of Article 7(1) of the EU Market Abuse
Regulation (Regulation 596/2014).
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 “aims,”
“believes,” “hope,” “estimates,” “anticipates,” “expects,”
“intends,” “may,” “will,” “should,” or “commitment” and include
statements argenx makes concerning argenx’ topline results from the
ADVANCE-SC study of VYVGART Hytrulo in ITP, its commitment to the
ITP patient community, its commitment to bringing VYVGART IV to ITP
patients in Japan, where the regulatory review is ongoing based on
the success of its first trial, and the expected timing of such
regulatory review decision, the expected timing of the topline
results for the registrational ADDRESS study, and its goal of
translating immunology breakthroughs into a world-class portfolio
of novel antibody-based medicines. 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 but
not limited to argenx’s additional analyses of the dataset from the
ADVANCE-SC study of VYVGART Hytrulo in ITP, expectations regarding
the inherent uncertainties associated with development of novel
drug therapies, preclinical and clinical trial and product
development activities and regulatory approval requirements,
including the approval of VYVGART IV for ITP patients in Japan and
the topline results of the registrational ADDRESS study for
pemphigus, the acceptance of our products and product candidates by
our patients as safe, effective and cost-effective, and the impact
of governmental laws and regulations on our business. 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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