Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced 20
abstracts across Dupixent® (dupilumab) and investigational therapy
itepekimab will be presented at the European Respiratory Society
(ERS) Congress 2024 being held from September 7 to 11 in Vienna,
Austria. These clinical and real-world abstracts presented in
collaboration with Sanofi include four oral presentations and
demonstrate the potential of targeting key drivers of type 2
inflammation and other pathways to address respiratory diseases,
such as COPD and asthma, and improve patient outcomes.
“The breadth of our presentations at the ERS Congress showcase
our commitment to advancing the management of a range of
difficult-to-treat respiratory diseases,” said George D.
Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief
Scientific Officer at Regeneron, and a principal inventor of
Dupixent. “Through our Dupixent clinical program, we have gained a
deep understanding of the biology of airway diseases. We are now
applying those insights to COPD, a complex and heterogenous
disease, and are excited by the remarkable potential of our COPD
research program investigating Dupixent, as well as our anti-IL-33
antibody itepekimab to support COPD patients regardless of smoking
history.”
Among the notable Dupixent presentations at ERS is a pooled
analysis of the previously reported Phase 3 BOREAS and NOTUS trials
in uncontrolled COPD with evidence of type 2 inflammation (i.e.,
raised blood eosinophils). In the trials, all patients were on
background maximal standard-of-care inhaled therapy (with nearly
all on triple therapy). BOREAS and NOTUS formed the basis of the
recent European Commission approval and regulatory submissions
around the world for Dupixent in certain patients with uncontrolled
COPD.
As shared in the abstract, the pooled analysis demonstrated that
Dupixent patients (n=938) experienced a 31% reduction in the
annualized rate of moderate or severe COPD exacerbations over 52
weeks compared to placebo (n=936; nominal p<0.0001). Additional
COPD data to be presented at the meeting will evaluate the impact
of Dupixent on daily symptom frequency and severity, exacerbations
and lung function regardless of baseline body mass index, airflow
obstruction, dyspnea (shortness of breath) and exercise capacity
measures. Safety results were generally consistent with the known
safety profile of Dupixent in its approved indications. Adverse
events more commonly observed with Dupixent (≥5%) compared to
placebo in either COPD trial were back pain, COVID-19, diarrhea,
headache and nasopharyngitis.
Additionally, new research will be shared from the Phase 4
VESTIGE trial, a novel imaging study evaluating the effects of
Dupixent on airway remodeling in certain adults with asthma. Two
poster presentations will show new data on the 4-week impact of
Dupixent treatment on airway inflammation, volume, and flow, and
mucus plugging, as well as outcomes for clinical remission after 4
and 24 weeks of treatment in adults with uncontrolled
moderate-to-severe asthma.
The full list of Regeneron and Sanofi presentations at ERS
includes:
Abstract title |
Abstract |
Presentingauthor |
Presentation date, time (CEST) |
COPD |
Reduction in exacerbations with itepekimab in former smokers with
chronic obstructive pulmonary disease (COPD) by prior exacerbation
frequency |
OA3645 Oral presentation |
Rabe, K.F. |
Monday, September 92:15-3:30 PM |
Dupilumab Efficacy and Safety in Patients with Moderate-to-Severe
COPD with Type 2 Inflammation: Pooled Analysis of BOREAS and NOTUS
Trials |
PA4787 Poster Presentation |
Bhatt, S. |
Tuesday, September 1012:30-2:00 PM |
Dupilumab improves respiratory symptoms in patients with
moderate-to-severe COPD with type 2 inflammation in phase 3 BOREAS
trial |
PA4786 Poster Presentation |
Papi, A. |
Tuesday, September 1012:30-2:00 PM |
Dupilumab improves quality of life in non-exacerbators with
moderate-to-severe COPD and type 2 inflammation: phase 3 BOREAS
trial |
PA4784 Poster Presentation |
Rabe, K.F. |
Tuesday, September 1012:30-2:00 PM |
Dupilumab improves lung function in non-exacerbators with
moderate-to-severe COPD with type 2 inflammation in phase 3 BOREAS
trial |
PA4785 Poster Presentation |
Rabe, K.F. |
Tuesday, September 1012:30-2:00 PM |
Dupilumab efficacy in patients with COPD and type 2 inflammation
irrespective of mortality riskscore |
PA4782 Poster Presentation |
Vogelmeier, C. |
Tuesday, September 1012:30-2:00 |
Asthma |
Clinical remission with dupilumab in children with uncontrolled,
moderate-to-severe, type 2 asthma (dupilumab) |
RCT3719 Late-Breaking Oral Presentation |
Bacharier, L. |
Monday, September 93:30-5:00 PM |
Impact of early transient increase in eosinophils in patients with
moderate-to-severe asthma on the long-term efficacy of dupilumab in
TRAVERSE |
OA2779 Oral Presentation |
Pavord, I. |
Monday, September 99:30-10:45 AM |
Dupilumab reduces mucus plugging and volume: phase 4 VESTIGE
trial |
OA3649 Oral Presentation |
Porsberg, C. |
Monday, September 92:35-3:30 PM |
Effectiveness of dupilumab vs omalizumab in patients with severe
asthma – The EU-ADVANTAGEstudy |
PA2171 Poster Presentation |
Canonica, G.W. |
Monday, September 98:00-9:30 AM |
Characteristics of long-term oral corticosteroid users stratified
by blood eosinophil count in the International Severe Asthma
Registry |
PA439 Poster Presentation |
Chan, J. |
Sunday, September 88:00-9:30 AM |
Phenotype and biomarkers in patients who initiated biologic therapy
stratified by oral corticosteroids use in the International Severe
Asthma Registry |
PA438 Poster Presentation |
Chan, J. |
Sunday, September 88:00-9:30 AM |
Dupilumab-treated patients with moderate-to-severe asthma are more
likely to meet clinical remission criteria: results from the
VESTIGE trial |
PA1202 Poster Presentation |
Lugogo, N.L. |
Sunday, September 812:30-2:00 PM |
Baseline Characteristics of Patients with Asthma Initiating
Dupilumab in a Real-World Setting: the RAPID Registry |
PA4484 Poster Presentation |
Lugogo, N.L. |
Tuesday, September 108:00-9:30 AM |
Early treatment response to dupilumab on airway inflammation,
airway dynamics, and mucus plugging in VESTIGE |
PA3933 Poster Presentation |
Papi, A. |
Tuesday, September 108:00-9:30 AM |
Real-world effectiveness of dupilumab vs benralizumab and vs
mepolizumab in severe asthma: The EU-ADVANTAGE study |
PA2170 Poster Presentation |
Virchow, J.C. |
Monday, September 98:00-9:30 AM |
Dupilumab improves lung function and reduces exacerbations despite
withdrawal of inhaled corticosteroids/long-acting beta
agonists |
PA1172 Late-Breaking Poster Presentation |
Wechsler, M.E. |
Sunday,September 812:30-2:00 PM |
Dupilumab Reduces Exacerbations and FeNO Levels and Improves Asthma
Control with Inhaled Corticosteroid Withdrawal: a Phase 2
Study |
PA5371 Poster Presentation |
Wechsler, M.E. |
Tuesday, September 1012:30-2:00 PM |
CRSwNP |
Baseline Characteristics of Patients with Chronic Rhinosinusitis
with Nasal Polyps and Coexisting Asthma Initiating Dupilumab in the
AROMA Global Registry |
PA425 Poster Presentation |
Heffler, E. |
Sunday, September 88:00-9:30 AM |
Initiation of dupilumab led to reduced use of oral corticosteroids
(OCS) and other medications over 12 months in patients with chronic
rhinosinusitis with nasal polyps (CRSwNP): A US real-world practice
study |
PA2177 Poster Presentation |
Lee, S.E. |
Monday, September 98:00-9:30 AM |
About DupixentDupixent, which was invented
using Regeneron’s proprietary VelocImmune® technology, 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. The Dupixent development program has shown
significant clinical benefit and a decrease in type 2 inflammation
in Phase 3 trials, establishing that IL-4 and IL-13 are key and
central drivers of the type 2 inflammation that plays a major role
in multiple related and often co-morbid diseases.
Dupixent has received regulatory approvals in more than 60
countries in one or more indications including certain patients
with atopic dermatitis, asthma, chronic rhinosinusitis with nasal
polyposis (CRSwNP), eosinophilic esophagitis (EoE), prurigo
nodularis, chronic spontaneous urticaria (CSU), and COPD in
different age populations. More than 950,000 patients are being
treated with Dupixent globally.
Dupilumab Development ProgramDupilumab is being
jointly developed by Regeneron and Sanofi under a global
collaboration agreement. To date, dupilumab has been studied across
more than 60 clinical trials involving more than 10,000 patients
with various chronic diseases driven in part by type 2
inflammation.
In addition to the currently approved indications, Regeneron and
Sanofi are studying dupilumab in a broad range of diseases driven
by type 2 inflammation or other allergic processes in Phase 3
trials, including chronic pruritus of unknown origin and bullous
pemphigoid. 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.
About ItepekimabItepekimab, which was invented
using Regeneron’s proprietary VelocImmune technology, is a fully
human monoclonal antibody that binds to and inhibits the signaling
of interleukin-33 (IL-33), an initiator and amplifier of airway
inflammation.
Itepekimab is currently under clinical investigation in two COPD
Phase 3 trials and its safety and efficacy have not been evaluated
by any regulatory authority.
About Regeneron's
VelocImmune®
TechnologyRegeneron's VelocImmune technology
utilizes a proprietary genetically engineered mouse platform
endowed with a genetically humanized immune system to produce
optimized fully human antibodies. When Regeneron's co-Founder,
President and Chief Scientific Officer George D. Yancopoulos was a
graduate student with his mentor Frederick W. Alt in 1985, they
were the first to envision making such a genetically humanized
mouse, and Regeneron has spent decades inventing and developing
VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos
and his team have used VelocImmune technology to create a
substantial proportion of all original, FDA-approved or authorized
fully human monoclonal antibodies. This includes REGEN-COV®
(casirivimab and imdevimab), Dupixent, Libtayo® (cemiplimab-rwlc),
Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza®
(evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and
odesivimab-ebgn) and Veopoz® (pozelimab-bbfg).
U.S. INDICATIONSDUPIXENT is a prescription
medicine used:
- to treat adults and children 6
months of age and older with moderate-to-severe eczema (atopic
dermatitis or AD) that is not well controlled with prescription
therapies used on the skin (topical), or who cannot use topical
therapies. DUPIXENT can be used with or without topical
corticosteroids. It is not known if DUPIXENT is safe and effective
in children with atopic dermatitis under 6 months of age.
- with other asthma medicines for the
maintenance treatment of moderate-to-severe eosinophilic or oral
steroid dependent asthma in adults and children 6 years of age and
older whose asthma is not controlled with their current asthma
medicines. DUPIXENT helps prevent severe asthma attacks
(exacerbations) and can improve your breathing. DUPIXENT may also
help reduce the amount of oral corticosteroids you need while
preventing severe asthma attacks and improving your breathing.
DUPIXENT is not used to treat sudden breathing problems. It is not
known if DUPIXENT is safe and effective in children with asthma
under 6 years of age.
- with other medicines for the
maintenance treatment of chronic rhinosinusitis with nasal
polyposis (CRSwNP) in adults whose disease is not controlled. It is
not known if DUPIXENT is safe and effective in children with
chronic rhinosinusitis with nasal polyposis under 18 years of
age.
- to treat adults and children 1 year
of age and older with eosinophilic esophagitis (EoE), who weigh at
least 33 pounds (15 kg). It is not known if DUPIXENT is safe and
effective in children with eosinophilic esophagitis under 1 year of
age, or who weigh less than 33 pounds (15 kg).
- to treat adults with prurigo
nodularis (PN). It is not known if DUPIXENT is safe and effective
in children with prurigo nodularis under 18 years of age.
IMPORTANT SAFETY INFORMATION
Do not use if you are allergic to dupilumab or
to any of the ingredients in DUPIXENT®.
Before using DUPIXENT, tell your healthcare provider
about all your medical conditions, including if you:
- have eye problems.
- have a parasitic (helminth) infection.
- are scheduled to receive any vaccinations. You should not
receive a “live vaccine” right before and during treatment with
DUPIXENT.
- are pregnant or plan to become pregnant. It is not known
whether DUPIXENT will harm your unborn baby.
- A pregnancy registry for women who take DUPIXENT during
pregnancy collects information about the health of you and your
baby. To enroll or get more information call 1-877-311-8972 or go
to https://mothertobaby.org/ongoing-study/dupixent/.
- are breastfeeding or plan to breastfeed. It is not known
whether DUPIXENT passes into your breast milk.
Tell your healthcare provider about all the medicines you take,
including prescription and over-the- counter medicines, vitamins,
and herbal supplements.
Especially tell your healthcare provider if you
are taking oral, topical, or inhaled corticosteroid medicines; have
asthma and use an asthma medicine; or have atopic dermatitis,
chronic rhinosinusitis with nasal polyposis, eosinophilic
esophagitis, or prurigo nodularis and also have asthma. Do
not change or stop your corticosteroid medicine or other
asthma medicine without talking to your healthcare provider. This
may cause other symptoms that were controlled by the corticosteroid
medicine or other asthma medicine to come back.
DUPIXENT can cause serious side effects,
including:
- Allergic reactions. DUPIXENT can cause allergic
reactions that can sometimes be severe. Stop using
DUPIXENT and tell your healthcare provider or get emergency help
right away if you get any of the following signs or symptoms:
breathing problems or wheezing, swelling of the face, lips, mouth,
tongue or throat, fainting, dizziness, feeling lightheaded, fast
pulse, fever, hives, joint pain, general ill feeling, itching, skin
rash, swollen lymph nodes, nausea or vomiting, or cramps in your
stomach-area.
- Eye problems. Tell your healthcare provider if
you have any new or worsening eye problems, including eye pain or
changes in vision, such as blurred vision. Your healthcare provider
may send you to an ophthalmologist for an exam if needed.
- Inflammation of your blood vessels. Rarely,
this can happen in people with asthma who receive DUPIXENT. This
may happen in people who also take a steroid medicine by mouth that
is being stopped or the dose is being lowered. It is not known
whether this is caused by DUPIXENT. Tell your healthcare provider
right away if you have: rash, chest pain, worsening shortness of
breath, a feeling of pins and needles or numbness of your arms or
legs, or persistent fever.
- Joint aches and pain. Some people who use
DUPIXENT have had trouble walking or moving due to their joint
symptoms, and in some cases needed to be hospitalized. Tell your
healthcare provider about any new or worsening joint symptoms. Your
healthcare provider may stop DUPIXENT if you develop joint
symptoms.
The most common side effects include:
- Eczema: injection site reactions, eye and
eyelid inflammation, including redness, swelling, and itching,
sometimes with blurred vision, dry eye, cold sores in your mouth or
on your lips, and high count of a certain white blood cell
(eosinophilia).
- Asthma: injection site reactions, high count
of a certain white blood cell (eosinophilia), pain in the throat
(oropharyngeal pain), and parasitic (helminth) infections.
- Chronic Rhinosinusitis with Nasal Polyposis:
injection site reactions, eye and eyelid inflammation, including
redness, swelling, and itching, sometimes with blurred vision, high
count of a certain white blood cell (eosinophilia), gastritis,
joint pain (arthralgia), trouble sleeping (insomnia), and
toothache.
- Eosinophilic Esophagitis: injection site
reactions, upper respiratory tract infections, cold sores in your
mouth or on your lips, and joint pain (arthralgia).
- Prurigo Nodularis: eye and eyelid
inflammation, including redness, swelling, and itching, sometimes
with blurred vision, herpes virus infections, common cold symptoms
(nasopharyngitis), dizziness, muscle pain, and diarrhea.
Tell your healthcare provider if you have any side effect that
bothers you or that does not go away.
These are not all the possible side effects of DUPIXENT. Call
your doctor for medical advice about side effects. You are
encouraged to report negative side effects of prescription drugs to
the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Use DUPIXENT exactly as prescribed by your healthcare provider.
It’s an injection given under the skin (subcutaneous injection).
Your healthcare provider will decide if you or your caregiver can
inject DUPIXENT. Do not try to prepare and inject
DUPIXENT until you or your caregiver have been trained by your
healthcare provider. In children 12 years of age and older, it’s
recommended DUPIXENT be administered by or under supervision of an
adult. In children 6 months to less than 12 years of age, DUPIXENT
should be given by a caregiver.
Please see accompanying full
Prescribing Information including Patient
Information.
About Regeneron Regeneron (NASDAQ: REGN) is a
leading biotechnology company that invents, develops and
commercializes life-transforming medicines for people with serious
diseases. Founded and led by physician-scientists, our unique
ability to repeatedly and consistently translate science into
medicine has led to numerous approved treatments and product
candidates in development, most 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, neurological
diseases, hematologic conditions, infectious diseases, and rare
diseases.
Regeneron pushes the boundaries of scientific discovery
and accelerates drug development using our proprietary
technologies, such as VelociSuite®, which produces optimized fully
human antibodies and new classes of bispecific antibodies. We are
shaping the next frontier of medicine with data-powered insights
from the Regeneron Genetics Center® and pioneering genetic medicine
platforms, enabling us to identify innovative targets and
complementary approaches to potentially treat or cure diseases.
For more information, please visit www.Regeneron.com or follow
Regeneron on LinkedIn, Instagram, Facebook or X.
Regeneron Forward-Looking Statements and Use of Digital
MediaThis press release includes forward-looking
statements that involve risks and uncertainties relating to future
events and the future performance of Regeneron
Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and
actual events or results may differ materially from these
forward-looking statements. Words such as “anticipate,” “expect,”
“intend,” “plan,” “believe,” “seek,” “estimate,” variations of such
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concern, and these risks and uncertainties include, among others,
the nature, timing, and possible success and therapeutic
applications of products marketed or otherwise commercialized by
Regeneron and/or its collaborators or licensees (collectively,
“Regeneron’s Products”) and product candidates being developed by
Regeneron and/or its collaborators or licensees (collectively,
“Regeneron’s Product Candidates”) and research and clinical
programs now underway or planned, including without limitation
Dupixent® (dupilumab) and itepekimab; uncertainty of the
utilization, market acceptance, and commercial success of
Regeneron’s Products and Regeneron’s Product Candidates and the
impact of studies (whether conducted by Regeneron or others and
whether mandated or voluntary), including the studies discussed or
referenced in this press release, on any of the foregoing or any
potential regulatory approval of Regeneron’s Products (such as
Dupixent) and Regeneron’s Product Candidates (such as itepekimab);
the likelihood, timing, and scope of possible regulatory approval
and commercial launch of Regeneron’s Product Candidates and new
indications for Regeneron’s Products, including itepekimab for the
treatment of chronic obstructive pulmonary disease as well as
Dupixent for the treatment of chronic pruritus of unknown origin,
bullous pemphigoid, and other potential indications; the ability of
Regeneron’s collaborators, licensees, suppliers, or other third
parties (as applicable) to perform manufacturing, filling,
finishing, packaging, labeling, distribution, and other steps
related to Regeneron’s Products and Regeneron’s Product Candidates;
the ability of Regeneron to manage supply chains for multiple
products and product candidates; safety issues resulting from the
administration of Regeneron’s Products (such as Dupixent) and
Regeneron’s Product Candidates (such as itepekimab) in patients,
including serious complications or side effects in connection with
the use of Regeneron’s Products and Regeneron’s Product Candidates
in clinical trials; determinations by regulatory and administrative
governmental authorities which may delay or restrict Regeneron’s
ability to continue to develop or commercialize Regeneron’s
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obligations and oversight impacting Regeneron’s Products, research
and clinical programs, and business, including those relating to
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Regeneron’s Products from third-party payers, including private
payer healthcare and insurance programs, health maintenance
organizations, pharmacy benefit management companies, and
government programs such as Medicare and Medicaid; coverage and
reimbursement determinations by such payers and new policies and
procedures adopted by such payers; competing drugs and product
candidates that may be superior to, or more cost effective than,
Regeneron’s Products and Regeneron’s Product Candidates; the extent
to which the results from the research and development programs
conducted by Regeneron and/or its collaborators or licensees may be
replicated in other studies and/or lead to advancement of product
candidates to clinical trials, therapeutic applications, or
regulatory approval; unanticipated expenses; the costs of
developing, producing, and selling products; the ability of
Regeneron to meet any of its financial projections or guidance and
changes to the assumptions underlying those projections or
guidance; the potential for any license, collaboration, or supply
agreement, including Regeneron’s agreements with Sanofi and Bayer
(or their respective affiliated companies, as applicable) to be
cancelled or terminated; the impact of public health outbreaks,
epidemics, or pandemics (such as the COVID-19 pandemic) on
Regeneron's business; and risks associated with intellectual
property of other parties and pending or future litigation relating
thereto (including without limitation the patent litigation and
other related proceedings relating to EYLEA® (aflibercept)
Injection), other litigation and other proceedings and government
investigations relating to the Company and/or its operations
(including the pending civil proceedings initiated or joined by the
U.S. Department of Justice and the U.S. Attorney's Office for the
District of Massachusetts), the ultimate outcome of any such
proceedings and investigations, and the impact any of the foregoing
may have on Regeneron’s business, prospects, operating results, and
financial condition. A more complete description of these and other
material risks can be found in Regeneron’s filings with
the U.S. Securities and Exchange Commission, including its
Form 10-K for the year ended December 31, 2023 and its Form
10-Q for the quarterly period ended June 30, 2024. Any
forward-looking statements are made based on management’s current
beliefs and judgment, and the reader is cautioned not to rely on
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not undertake any obligation to update (publicly or otherwise) any
forward-looking statement, including without limitation any
financial projection or guidance, whether as a result of new
information, future events, or otherwise.
Regeneron uses its media and investor relations website and
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Regeneron Contacts:Media
RelationsHannah KwaghTel: +1
914-847-6314Hannah.Kwagh@regeneron.com |
Investor RelationsVesna TosicTel:
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