Dupixent®
(dupilumab)
significantly
improved
itch and
hives in
patients with
chronic
spontaneous
urticaria, a
step
forward in
demonstrating the
role of
type 2
inflammation in
these
patients
- Fifth disease that Dupixent has demonstrated positive pivotal
results
- Phase 3 trial met its primary endpoints and all key secondary
endpoints at 24 weeks, showing Dupixent nearly doubled reduction in
itch and urticaria activity scores
- CSU results further demonstrate the potential of targeting IL-4
and IL-13 via IL-4Ra blockade in improving diseases with components
of type 2 inflammation
- Approximately 300,000 people in the U.S. have moderate to
severe CSU that does not respond adequately to antihistamines
alone
- Data continue to support well-established safety profile of
Dupixent
PARIS and TARRYTOWN, N.Y. –
July 29,
2021 - A pivotal Phase 3 trial evaluating
Dupixent® (dupilumab) in patients with moderate-to-severe chronic
spontaneous urticaria (CSU), an inflammatory skin disease, met its
primary endpoints and all key secondary endpoints at 24 weeks.
Adding Dupixent to standard-of-care antihistamines significantly
reduced itch and hives for biologic-naïve patients, compared to
those treated with antihistamines alone (placebo) in Study A (the
first of two trials) of the LIBERTY CUPID clinical program.
“The chronic nature of CSU, coupled with intense itch, causes
both a physical and emotional burden on people who have not found
an effective treatment,” said John Reed, M.D., Ph.D., Global Head
of Research and Development at Sanofi. “This is the fifth
inflammatory disease in which Dupixent has demonstrated a
significant improvement in symptoms and disease manifestations in
Phase 3 pivotal studies. The success of this trial underscores the
agility of our clinical operations team considering the pandemic
conditions and underscores our ability to deliver on an aggressive
timeline for addressing a significant unmet need for this patient
population.”
“This is the first Phase 3 trial to show that by targeting IL-4
and IL-13, Dupixent can address the debilitating symptoms of
chronic spontaneous urticaria like persistent itch and hives when
standard-of-care antihistamines cannot sufficiently control the
disease,” said George D. Yancopoulos, M.D., Ph.D., President and
Chief Scientific Officer at Regeneron. “These data add to the
increasing body of evidence that using Dupixent can reduce the
disease burden of a diverse range of dermatologic, respiratory and
gastrointestinal diseases. By early 2022 we look forward to
reporting results from a second trial in patients who were unable
to control their chronic spontaneous urticaria with another
biologic medicine, as well other trial results in additional
dermatologic diseases.”
CSU is a chronic inflammatory skin disease
characterized by the sudden onset of hives on the skin and/or
swelling deep under the skin. Despite standard-of-care treatment,
people with CSU often experience symptoms including a persistent
itch or burning sensation, which can be debilitating and
significantly impact quality of life. Swelling often occurs on the
face, hands and feet, but can also affect the throat and upper
airways. CSU is typically treated with antihistamines but for up to
50% of people living with CSU their disease remains uncontrolled
and available treatment options are few. CSU is the fifth
inflammatory disease for which Dupixent has achieved positive Phase
3 data, including atopic dermatitis, asthma, chronic rhinosinusitis
with nasal polyposis and eosinophilic esophagitis (EoE,
investigational).
In the trial (n=138), adding Dupixent to standard-of-care
antihistamines nearly doubled the reduction in itch and urticaria
activity compared to standard-of-care alone at 24 weeks:
- 63% reduction in itch severity with
Dupixent vs 35% with standard-of-care (antihistamines) as measured
by a 0-21-point itch severity scale (10.24-point reduction with
Dupixent vs 6.01-point reduction with standard-of-care)
(p<0.001), the primary endpoint in the US (secondary endpoint in
the EU) with continuous improvement out to week 24.
- 65% reduction in urticaria activity
(itch and hives) severity with Dupixent vs 37% with
standard-of-care, as measured by a 0-42-point urticaria activity
scale, (20.53-point reduction with Dupixent vs 12.00-point
reduction with standard-of-care) (p<0.001), the primary endpoint
in the EU (secondary endpoint in the US) with continuous
improvement out to week 24.
The trial demonstrated safety results similar to the known
safety profile of Dupixent in its approved indications. For the
24-week treatment period, the occurrence of treatment emergent
adverse events were generally similar between the Dupixent and
placebo groups (50% of Dupixent patients and 59% of placebo
patients). The most common adverse events were injection site
reactions (11% Dupixent, 13% placebo).
The potential use of Dupixent in CSU and EoE is currently under
clinical development, and the safety and efficacy have not been
fully evaluated by any regulatory authority.
About the Dupixent CUPID
trial
Study A of the Phase 3 randomized, double-blind,
placebo-controlled clinical program evaluated the efficacy and
safety of Dupixent as an add-on therapy to standard-of-care H1
antihistamines compared to antihistamines in 138 patients aged 6
years and older with CSU who remained symptomatic despite
antihistamine use and who were not previously treated with anti-IgE
therapeutics.
The primary endpoints assessed the change from baseline in itch
(measured by the weekly itch severity score [ISS7]) at 24 weeks and
the change from baseline in itch and hives (measured by the weekly
urticaria activity score [UAS7]) at 24 weeks.
Study B of the clinical trial will evaluate
Dupixent in adults and adolescents who remain symptomatic despite
standard-of-care treatment and are intolerant or incomplete
responders to an anti-IgE therapeutic (omalizumab). That study is
expected to read out in H1 2022. Sanofi and Regeneron plan to begin
submissions in 2022. In addition to CSU, Sanofi and Regeneron are
also studying Dupixent in chronic inducible urticaria triggered by
cold (LIBERTY-CINDU CUrIADS program) in an ongoing Phase 3
trial.
About Dupixent
Dupixent is a fully human monoclonal antibody
that inhibits the signaling of the interleukin-4 (IL-4) and
interleukin-13 (IL-13) pathways and is not an immunosuppressant.
IL-4 and IL-13 are key and central drivers of the type 2
inflammation that plays a major role in asthma, chronic
rhinosinusitis with nasal polyposis (CRSwNP), atopic dermatitis,
eosinophilic esophagitis and may contribute to CSU.
In the United States and Europe, Dupixent is
approved for patients 6 years and older with moderate-to-severe
atopic dermatitis, patients 12 years and older with
moderate-to-severe asthma, and in adults with uncontrolled CRSwNP.
Dupixent is also approved in one or more of these indications in
more than 60 countries around the world and more than 300,000
patients have been treated globally.
Dupilumab Development ProgramTo
date, Dupixent has been studied across 50 clinical trials involving
10,000 patients with various chronic diseases driven by type 2
inflammation.
Sanofi and Regeneron are studying dupilumab in a
broad range of diseases driven by type 2 inflammation or other
allergic processes, including pediatric asthma (6 to 11 years of
age, Phase 3), chronic obstructive pulmonary disease with evidence
of type 2 inflammation (Phase 3), pediatric atopic dermatitis (6
months to 5 years of age, Phase 3), eosinophilic esophagitis (Phase
3), bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3),
chronic spontaneous urticaria (Phase 3), chronic inducible
urticaria-cold (Phase 3), chronic rhinosinusitis without nasal
polyposis (Phase 3), allergic fungal rhinosinusitis (Phase 3),
allergic bronchopulmonary aspergillosis (Phase 3) and peanut
allergy (Phase 2). These potential uses of dupilumab are currently
under clinical investigation, and the safety and efficacy in these
conditions have not been fully evaluated by any regulatory
authority. Dupilumab is being jointly developed by Sanofi and
Regeneron under a global collaboration agreement.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading
biotechnology company that invents life-transforming medicines for
people with serious diseases. Founded and led for over 30 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to nine
FDA-approved treatments and numerous product candidates in
development, almost all of which were homegrown in our
laboratories. Our medicines and pipeline are designed to help
patients with eye diseases, allergic and inflammatory diseases,
cancer, cardiovascular and metabolic diseases, pain, hematologic
conditions, infectious diseases and rare diseases.
Regeneron is accelerating and improving the
traditional drug development process through our
proprietary VelociSuite® technologies, such
as VelocImmune®, which uses unique genetically humanized
mice to produce optimized fully human antibodies and bispecific
antibodies, and through ambitious research initiatives such as the
Regeneron Genetics Center, which is conducting one of the largest
genetics sequencing efforts in the world.
For additional information about the company,
please visit www.regeneron.com or follow @Regeneron on Twitter.
About Sanofi
Sanofi is dedicated to supporting people through
their health challenges. We are a global biopharmaceutical company
focused on human health. We prevent illness with vaccines, provide
innovative treatments to fight pain and ease suffering. We stand by
the few who suffer from rare diseases and the millions with
long-term chronic conditions.
With more than 100,000 people in 100 countries,
Sanofi is transforming scientific innovation into healthcare
solutions around the globe.
Sanofi Media Relations
Contacts Ashleigh Koss
Tel: +1 (908)
205-2572 Ashleigh.Koss@sanofi.com
Sandrine
Guendoul Tel.: +33
(0)6 25 09 14
25 Sandrine.Guendoul@sanofi.com
Sally BainTel.: +1 (781) 264-1091Sally.Bain@sanofi.com
Regeneron Media Relations ContactsHannah
KwaghTel: +1 914-847-6314Hannah.Kwagh@regeneron.com
Sanofi Investor Relations Contacts
Paris Eva Schaefer-Jansen Arnaud
Delepine Nathalie Pham
Sanofi Investor Relations Contacts
North America Felix Lauscher Fara
Berkowitz Suzanne Greco
Tel.: +33 (0)1 53 77 45 45
investor.relations@sanofi.com
https://www.sanofi.com/en/investors/contact
Regeneron Investor RelationsVesna TosicTel: +1
914-847-5443Vesna.Tosic@regeneron.com
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