TARRYTOWN, N.Y. and
PARIS, June
21, 2019 /PRNewswire/ --
REGN3500 monotherapy significantly reduced loss
of asthma control and improved lung function compared to
placebo
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi
today announced that a Phase 2 proof-of-concept trial evaluating
the investigational IL-33 antibody REGN3500 (SAR440340) met the primary endpoint of
improvement in loss of asthma control when comparing REGN3500
monotherapy to placebo. The trial also met a key secondary
endpoint, demonstrating REGN3500 monotherapy significantly improved
lung function compared to placebo.
In the trial, the greatest improvement was observed in patients
with blood eosinophil levels ≥300 cells/microliter. Patients
treated with Dupixent® (dupilumab) monotherapy did
numerically better than REGN3500 across all endpoints, although the
trial was not powered to show differences between active treatment
arms. The combination of REGN3500 and Dupixent also did not
demonstrate increased benefit compared to Dupixent monotherapy in
this trial. More detailed results will be presented at an upcoming
medical meeting.
"This trial suggests that REGN3500 may provide an alternative
targeted approach for patients suffering from asthma," said
George D. Yancopoulos, M.D., Ph.D.,
President and Chief Scientific Officer at Regeneron. "We look
forward to working with Sanofi to advance REGN3500 through our
asthma clinical trial program, as well as continuing our ongoing
trials in atopic dermatitis and chronic obstructive pulmonary
disease."
Adverse events (AEs) occurred in 61.6% of patients who received
REGN3500, 66.2% of patients receiving both REGN3500 and Dupixent,
56.8% of patients who received Dupixent and 64.9% of patients who
received placebo. The incidence of serious AEs and AEs leading to
treatment discontinuations was low.
Despite standard-of-care treatment with inhaled corticosteroid
(ICS) and long-acting beta-agonist (LABA) therapy, people with
moderate-to-severe asthma often have inadequately controlled,
persistent symptoms that may make them suitable for treatment with
a biologic therapy. These people live with coughing, wheezing and
difficulty breathing, and are at risk of severe asthma attacks that
may require emergency room visits or hospitalizations.
"Asthma is a heterogeneous disease and not everyone experiences
it in the same way. Therefore, there is value in evaluating new
therapies with distinct and novel mechanisms such as anti-IL-33,"
said Steve Pascoe, M.D., Head of
Immuno-Inflammation Development at Sanofi. "We have ongoing
studies for REGN3500 in atopic dermatitis and chronic
obstructive pulmonary disease. We will evaluate the results of
these studies as well as the findings in asthma to determine the
best path forward for this therapy."
REGN3500 is a fully-human monoclonal antibody that inhibits
interleukin-33 (IL-33), a protein that is believed to play a key
role in type 1 and type 2 inflammation. Preclinical research showed
REGN3500 blocked several markers of both types of inflammation. In
moderate-to-severe asthma, there can be multiple sources of
underlying inflammation that new therapies may help address.
About the Phase 2 Trial
The trial was a randomized,
double-blind, placebo-controlled, 12-week proof-of-concept trial
that enrolled 296 adult patients with moderate-to-severe asthma who
were not well controlled on LABA and ICS therapy. Patients were
randomized into four treatment groups: REGN3500 plus placebo,
REGN3500 plus Dupixent, Dupixent plus placebo, and placebo. All
patients received fluticasone/salmeterol as the ICS/LABA
maintenance therapy, which was withdrawn during the trial. At four
weeks post-randomization, the LABA was withdrawn, and between six
and nine weeks the ICS was tapered to withdrawal. Patients
continued without ICS/LABA maintenance therapy until 12 weeks. If a
patient experienced loss of asthma control (LOAC) during the trial,
they resumed their prescreening ICS/LABA maintenance therapy and
entered the safety follow-up period.
The primary endpoint was the proportion of patients who
experienced LOAC on REGN3500 with or without Dupixent, compared to
placebo.
About the REGN3500 Development Program
Regeneron and
Sanofi are currently studying REGN3500 in respiratory and
dermatological diseases where inflammation is thought to play an
underlying role. REGN3500 is being studied in Phase 2 trials for
asthma, chronic obstructive pulmonary disease and atopic
dermatitis. These potential uses are investigational and the safety
and efficacy have not been evaluated by any regulatory authority.
REGN3500 was invented using Regeneron's proprietary
VelocImmune® technology that yields optimized
fully-human antibodies, and is being developed jointly by Regeneron
and Sanofi as part of a global collaboration agreement.
About Dupixent® (dupilumab)
Dupixent is a
fully-human monoclonal antibody specifically designed to inhibit
the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13),
two key proteins that may play a central role in the type 2
inflammation that underlies asthma as well as other allergic and
atopic diseases.
Dupixent is approved in the U.S. for the treatment of people 12
years of age and older with moderate-to-severe atopic dermatitis
(eczema) that is not well controlled with prescription therapies
used on the skin (topical), or who cannot use topical therapies;
and for use with other asthma medicines for the maintenance
treatment of moderate-to-severe asthma in people aged 12 years and
older whose asthma is not controlled with their current asthma
medicines. Dupixent is also approved for certain patients with
moderate-to-severe atopic dermatitis and severe asthma in the
European Union and Japan.
In addition to the currently approved indications, Regeneron and
Sanofi are also studying dupilumab for additional diseases driven
by allergic and other type 2 inflammation, including chronic
rhinosinusitis with nasal polyps (Phase 3 completed),
pediatric asthma and atopic dermatitis (6 to 11 years of age, Phase
3), pediatric atopic dermatitis (6 months to 5 years of age, Phase
2/3), eosinophilic esophagitis (Phase 3), chronic obstructive
pulmonary disease (Phase 3), and food and environmental allergies
(Phase 2). These potential uses, and its use in combination with
REGN3500, are investigational and the safety and efficacy have not
been evaluated by any regulatory authority.
For more information on dupilumab clinical trials please visit
www.clinicaltrials.gov.
U.S. INDICATIONS OF DUPIXENT
DUPIXENT is a prescription medicine used:
- to treat people 12 years of age and older with
moderate-to-severe atopic dermatitis (eczema) 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 12
years of age.
- with other asthma medicines for the maintenance treatment of
moderate-to-severe asthma in people aged 12 years 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 12 years of
age.
IMPORTANT SAFETY INFORMATION FOR U.S. PATIENTS TAKING
DUPIXENT
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 (if you also have atopic dermatitis)
- have a parasitic (helminth) infection
- are taking oral, topical, or inhaled corticosteroid medicines.
Do not stop taking your corticosteroid medicines unless
instructed by your healthcare provider. This may cause other
symptoms that were controlled by the corticosteroid medicine to
come back.
- are scheduled to receive any vaccinations. You should not
receive a "live vaccine" if you are treated with DUPIXENT.
- are pregnant or plan to become pregnant. It is not known
whether DUPIXENT will harm your unborn baby.
- 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. If you are taking asthma medicines, do not
change or stop your asthma medicine without talking to your
healthcare provider.
DUPIXENT can cause serious side
effects, including:
- Allergic reactions (hypersensitivity), including a severe
reaction known as anaphylaxis. Stop using DUPIXENT and tell
your healthcare provider or get emergency help right away if you
get any of the following symptoms: breathing problems, fever,
general ill feeling, swollen lymph nodes, swelling of the face,
mouth and tongue, hives, itching, fainting, dizziness, feeling
lightheaded (low blood pressure), joint pain, or skin rash.
- Eye problems. If you have atopic dermatitis, tell your
healthcare provider if you have any new or worsening eye problems,
including eye pain or changes in vision.
- Inflammation in 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, shortness of breath, persistent fever, chest pain,
or a feeling of pins and needles or numbness of your arms or
legs.
The most common side effects include injection site
reactions, pain in the throat (oropharyngeal pain) and cold sores
in your mouth or on your lips. Eye and eyelid inflammation,
including redness, swelling and itching have been seen in patients
who have atopic dermatitis.
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. DUPIXENT is an injection
given under the skin (subcutaneous injection). If your healthcare
provider decides that you or a caregiver can give DUPIXENT
injections, you or your caregiver should receive training on the
right way to prepare and inject DUPIXENT. Do not try to
inject DUPIXENT until you have been shown the right way by your
healthcare provider. In adolescents 12 years of age and older, it
is recommended that DUPIXENT be administered by or under
supervision of an adult.
Please see accompanying full Prescribing Information
including Patient Information.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading
biotechnology company that invents life-transforming medicines for
people with serious diseases. Founded and led for 30 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to seven
FDA-approved treatments and numerous product candidates in
development, all of which were homegrown in our laboratories. Our
medicines and pipeline are designed to help patients with eye
disease, allergic and inflammatory diseases, cancer, cardiovascular
and metabolic diseases, neuromuscular diseases, infectious diseases
and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary
VelociSuite® technologies, such as
VelocImmune® which produces optimized fully-human
antibodies, and 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, Empowering Life
Regeneron Forward-Looking Statements and Use of Digital
Media
This 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 words, and similar expressions are
intended to identify such forward-looking statements, although not
all forward-looking statements contain these identifying words.
These statements concern, and these risks and uncertainties
include, among others, the nature, timing, and possible success and
therapeutic applications of Regeneron's products, product
candidates, and research and clinical programs now underway or
planned, including without limitation REGN3500 (as a monotherapy or
in combination with Dupixent® (dupilumab) Injection, as
applicable) for the treatment of asthma, chronic obstructive
pulmonary disease ("COPD"), atopic dermatitis, and other potential
indications, as well as dupilumab as a monotherapy for the
treatment of chronic rhinosinusitis with nasal polyps, pediatric
asthma and atopic dermatitis, eosinophilic esophagitis, COPD, food
and environmental allergies, and other potential indications;
unforeseen safety issues resulting from the administration of
products and product candidates in patients, including serious
complications or side effects in connection with the use of
Regeneron's product candidates (such as REGN3500 and dupilumab,
either as a monotherapy or in combination) in clinical trials; the
extent to which the results from the research and development
programs conducted by Regeneron or its collaborators (including
those discussed in this press release) may be replicated in other
studies and lead to therapeutic applications; the likelihood,
timing, and scope of possible regulatory approval and commercial
launch of Regeneron's late-stage product candidates and new
indications for marketed products; ongoing regulatory obligations
and oversight impacting Regeneron's marketed products, research and
clinical programs, and business, including those relating to
patient privacy; determinations by regulatory and administrative
governmental authorities which may delay or restrict Regeneron's
ability to continue to develop or commercialize Regeneron's
products and product candidates; competing drugs and product
candidates that may be superior to Regeneron's products and product
candidates; uncertainty of market acceptance and commercial success
of Regeneron's products and product candidates and the impact of
studies (whether conducted by Regeneron or others and whether
mandated or voluntary) on the commercial success of Regeneron's
products and product candidates; the ability of Regeneron to
manufacture and manage supply chains for multiple products and
product candidates; the ability of Regeneron's collaborators,
suppliers, or other third parties (as applicable) to perform
manufacturing, filling, finishing, packaging, labeling,
distribution, and other steps related to Regeneron's products and
product candidates; the availability and extent of reimbursement of
the Company'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; 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 or collaboration agreement,
including Regeneron's agreements with Sanofi, Bayer, and Teva
Pharmaceutical Industries Ltd. (or their respective affiliated
companies, as applicable), to be cancelled or terminated without
any further product success; 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, Dupixent, and Praluent®
(alirocumab) Injection, the ultimate outcome of any such
proceedings, 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 fiscal
year ended December 31, 2018 and its
Form 10-Q for the quarterly period ended March 31, 2019. Any forward-looking statements
are made based on management's current beliefs and judgment, and
the reader is cautioned not to rely on any forward-looking
statements made by Regeneron. Regeneron does not undertake any
obligation to update publicly 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
social media outlets to publish important information about the
Company, including information that may be deemed material to
investors. Financial and other information about Regeneron is
routinely posted and is accessible on Regeneron's media and
investor relations website (http://newsroom.regeneron.com) and its
Twitter feed (http://twitter.com/regeneron).
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as
defined in the Private Securities Litigation Reform Act of 1995, as
amended. Forward-looking statements are statements that are not
historical facts. These statements include projections and
estimates and their underlying assumptions, statements regarding
plans, objectives, intentions and expectations with respect to
future financial results, events, operations, services, product
development and potential, and statements regarding future
performance. Forward-looking statements are generally identified by
the words "expects", "anticipates", "believes", "intends",
"estimates", "plans" and similar expressions. Although Sanofi's
management believes that the expectations reflected in such
forward-looking statements are reasonable, investors are cautioned
that forward-looking information and statements are subject to
various risks and uncertainties, many of which are difficult to
predict and generally beyond the control of Sanofi, that could
cause actual results and developments to differ materially from
those expressed in, or implied or projected by, the forward-looking
information and statements. These risks and uncertainties include
among other things, the uncertainties inherent in research and
development, future clinical data and analysis, including post
marketing, decisions by regulatory authorities, such as the FDA or
the EMA, regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential
of such product candidates, the absence of guarantee that the
product candidates if approved will be commercially successful, the
future approval and commercial success of therapeutic alternatives,
Sanofi's ability to benefit from external growth opportunities
and/or obtain regulatory clearances, risks associated with
intellectual property and any related pending or future litigation
and the ultimate outcome of such litigation, trends in
exchange rates and prevailing interest rates, volatile economic
conditions, the impact of cost containment initiatives and
subsequent changes thereto, the average number of shares
outstanding as well as those discussed or identified in the public
filings with the SEC and the AMF made by Sanofi, including those
listed under "Risk Factors" and "Cautionary Statement Regarding
Forward-Looking Statements" in Sanofi's annual report on Form 20-F
for the year ended December 31, 2018.
Other than as required by applicable law, Sanofi does not undertake
any obligation to update or revise any forward-looking information
or statements.
Regeneron
Contacts:
Media
Relations
Sharon
Chen
Tel: +1 (914)
847-1546
Sharon.Chen@regeneron.com
|
Investor
Relations
Justin
Holko
Tel: +1 (914)
847-7786
Justin.Holko@regeneron.com
|
Sanofi
Contacts:
Media
Relations
Ashleigh
Koss
Tel: +1 (908)
981-8745
Ashleigh.Koss@sanofi.com
|
Investor
Relations
George
Grofik
Tel: +33 (0)1 53 77
45 45
ir@sanofi.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.