Sanofi and Regeneron Announce Positive
Phase 2 Study Results for Dupilumab in Patients With Active
Moderate-to-Severe Eosinophilic Esophagitis
- Late-breaking oral abstract
presented at the World Congress of Gastroenterology -
Paris, France and
Tarrytown, N.Y. - October 16, 2017 - Sanofi and
Regeneron Pharmaceuticals, Inc. today announced positive results
from a Phase 2 investigational study of dupilumab in adults with
active moderate-to-severe eosinophilic esophagitis. The study
showed that patients who received dupilumab weekly reported a
significant improvement in the ability to swallow versus placebo.
The results of this study were presented at the World Congress of
Gastroenterology (WCOG) held in partnership with The American
College of Gastroenterology Annual Scientific Meeting (ACG 2017) in
Orlando, Florida.
Eosinophilic esophagitis is a chronic, allergic
inflammatory disease that damages the esophagus and prevents it
from working properly, leading to difficulties swallowing and food
impaction.[1] Food allergies are the main cause of eosinophilic
esophagitis in a large number of patients. Corresponding with the
increase in incidence of allergic diseases in the overall
population, eosinophilic esophagitis is rapidly increasing in
incidence.
The primary endpoint of the study was the change
from baseline to week 10 in the Straumann Dysphagia Instrument
(SDI) score, a patient-reported measure of swallowing difficulty on
a 0-9 point scale, with 9 indicating more severe symptoms. A total
of 47 patients were randomized into two treatment groups in this
12-week treatment study and both groups had a mean baseline SDI
score of 6.4. Patients received dupilumab 300 mg weekly following a
600 mg loading dose or placebo. At week 10, patients who
received 300 mg weekly reported a significant improvement in the
ability to swallow with a 3 point reduction in their SDI score (45
percent improvement) compared to 1.3 (19 percent improvement) for
those patients who received placebo (p=0.0304).
Secondary endpoints of the study included
measures of the impact of dupilumab on endoscopic and
histopathologic measures of disease severity, as well as symptoms.
The results include:
- The mean change in the Eosinophilic Esophagitis Endoscopic
Reference Score (EoE-EREFS) was significantly reduced by 1.9 from
baseline (48 percent improvement) in patients who received
dupilumab weekly compared to 0.3 (7 percent improvement) for those
who received placebo at 12 weeks (p=0.0006). EoE-EREFS is a visual
measure of disease severity (inflammation and fibrosis in the
esophagus) on a 0-8 point scale, with 8 indicating more severe
disease. The mean baseline score for the dupilumab group was 3.9
and for the placebo group was 4.3.
- The mean percent change in overall peak intraepithelial
eosinophil count from baseline to 12 weeks was significantly
reduced by 93 percent from baseline in patients who received
dupilumab weekly compared to an increase of 14 percent in those who
received placebo (p<0.0001).
- The mean percent change in a composite measure of symptoms and
quality of life, as measured by Eosinophilic Esophagitis Symptom
Activity Index (EEsAI), was numerically improved (although not
statistically significant) by 35 percent in patients who received
dupilumab weekly compared to an 11 percent improvement for those
who received placebo at 10 weeks (p=0.085).
"Clinical manifestations of eosinophilic
esophagitis in adults include difficulty swallowing and
food impaction, which are consequences of pathological
structural changes to the esophagus. Natural history studies have
demonstrated an association between duration of untreated disease
and the
development of these esophageal changes," said
Ikuo Hirano, M.D., Professor of Medicine, Northwestern University
Feinberg School of Medicine. "Currently, there are no
FDA-approved therapies for eosinophilic esophagitis. In this study,
dupilumab, a monoclonal antibody targeting IL-4 and IL-13,
significantly improved patients' ability to swallow, inflammation
of the esophagus, and endoscopic signs of the disease. These
positive Phase 2 results support further clinical development of
dupilumab for patients with eosinophilic esophagitis."
There were no new significant safety
concerns in this trial. Higher rates of injection site reactions
were observed on Dupilumab versus placebo.
Clinical and preclinical research indicates that
the IL-4/IL-13 pathway may have an important role in allergic or
Type 2 inflammation. Dupilumab, an antibody that inhibits IL-4/13
signaling, has been approved in the U.S. and EU for
moderate-to-severe atopic dermatitis and has demonstrated clinical
activity in two other investigational areas under study (asthma and
nasal polyps).
Eosinophilic esophagitis is a chronic disease
characterized by high levels of eosinophils in the esophagus.
The results of investigational IL-5 blocking
studies in eosinophilic esophagitis suggest that eosinophils
may act as a biomarker of broader allergic or Type 2 inflammation
in the esophagus, but that eosinophils may not be solely
responsible for disease activity. In the study presented today, the
observed symptomatic and anatomic improvements associated with
dupilumab, together with this reduction of eosinophils, suggest
that dupilumab may have the potential to reverse multiple aspects
of Type 2 inflammation in eosinophilic esophagitis.
Current treatment options for people with
moderate-to-severe eosinophilic esophagitis are limited to diet
modification, corticosteroids or surgery. The disease can affect
patient's health-related quality of life, including altered eating
behaviors and pain when swallowing. People with active,
moderate-to-severe eosinophilic esophagitis live with the risk of
complete blockage or injury to their esophagus because of food
impaction, and emergency care is often required for severe
obstructions.
Dupilumab recently received Orphan Drug
Designation from the FDA for the potential treatment of
eosinophilic esophagitis. This status is given to investigational
medicines being developed for the treatment of rare diseases or
conditions that affect fewer than 200,000 people in the United
States.
The potential use of dupilumab in eosinophilic
esophagitis is currently under clinical development and the safety
and efficacy have not been fully evaluated by any regulatory
authority.
About DupilumabDupixent® (dupilumab) is
the first and only biologic medicine FDA-approved for the treatment
of adults with moderate-to-severe atopic dermatitis (AD) whose
disease is not adequately controlled with topical prescription
therapies. Dupixent is also the first targeted biologic in the
European Union to receive marketing authorization for use in adults
with moderate-to-severe atopic dermatitis who are candidates for
systemic therapy.
Dupilumab is a human monoclonal antibody that is
designed to simultaneously inhibit overactive signaling of IL-4 and
IL-13 cytokines, one of the root causes of Type 2 inflammation.
Sanofi and Regeneron are studying dupilumab in a broad range of
clinical development programs for diseases that are driven by Type
2 inflammation, including pediatric atopic dermatitis (Phase 3),
uncontrolled persistent asthma (Phase 3), and nasal polyps (Phase
3). These potential uses are investigational and the safety and
efficacy have not been evaluated by any regulatory authority.
Dupilumab is being jointly developed by Regeneron and Sanofi under
a global collaboration agreement.
For more information on dupilumab clinical
trials please visit www.clinicaltrials.gov.
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
- have asthma
- 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 have
asthma and 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. Stop using DUPIXENT and go to
the nearest hospital emergency room if you get any of the following
symptoms: fever, general ill feeling, swollen lymph nodes, hives,
itching, joint pain, or skin rash.
- Eye problems. Tell your healthcare provider
if you have any new or worsening eye problems, including eye pain
or changes in vision.
The most common side effects
include injection site reactions, eye and eyelid inflammation,
including redness, swelling and itching, and cold sores in your
mouth or on your lips.
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 may report side
effects to FDA at 1-800-FDA-1088.
Use DUPIXENT exactly as prescribed. 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.
Please click here for the full
Prescribing Information. The patient information is
available here.
INDICATION
DUPIXENT is used to treat adult patients 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. DUPIXENT is
administered by subcutaneous injection every two weeks after an
initial loading dose.
About Sanofi Sanofi, a global healthcare
leader, discovers, develops and distributes therapeutic solutions
focused on patients' needs. Sanofi is organized into five global
business units: Diabetes and Cardiovascular, General Medicines and
Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer
Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New
York (NYSE: SNY).
Sanofi Genzyme focuses on developing specialty
treatments for debilitating diseases that are often difficult to
diagnose and treat, providing hope to patients and their
families.
About Regeneron Pharmaceuticals,
Inc.Regeneron (NASDAQ: REGN) is a leading biotechnology company
that invents life-transforming medicines for people with serious
diseases. Founded and led for nearly 30 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to six
FDA-approved treatments and over a dozen product candidates in
development, all of which were homegrown in our laboratories. Our
medicines and pipeline are designed to help patients with eye
disease, heart disease, allergic and inflammatory diseases, pain,
cancer, and infectious and rare diseases.
Regeneron is accelerating and improving the
traditional drug development process through its unique
VelociSuite® technologies, including VelociGene® and VelocImmune®,
and ambitious initiatives such as The Regeneron Genetics Center,
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.
Sanofi Forward-Looking StatementsThis
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 regarding
the marketing and other potential of the product, or regarding
potential future revenues from the product. 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, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the absence of guarantee that
the product will be commercially successful, the uncertainties
inherent in research and development, including future clinical
data and analysis of existing clinical data relating to the
product, including post marketing, unexpected safety, quality or
manufacturing issues, competition in general, risks associated with
intellectual property and any related future litigation and the
ultimate outcome of such litigation, and volatile economic
conditions, as well as those risks 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, 2016. Other than as
required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or
statements.
Regeneron Forward-Looking Statements and Use
of Digital Media This news 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 Dupixent®
(dupilumab) Injection; 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, such as Dupixent for the treatment of active
moderate-to-severe eosinophilic esophagitis other potential
indications; the extent to which the results from the research and
development programs conducted by Regeneron or its collaborators
may be replicated in later studies and lead to therapeutic
applications; unforeseen safety issues and possible liability
resulting from the administration of products and product
candidates in patients, including without limitation Dupixent;
serious complications or side effects in connection with the use of
Regeneron's products and product candidates (such as Dupixent) in
clinical trials; coverage and reimbursement determinations by
third-party payers, including Medicare, Medicaid, and pharmacy
benefit management companies; ongoing regulatory obligations and
oversight impacting Regeneron's marketed products, research and
clinical programs, and business, including those relating to the
enrollment, completion, and meeting of the relevant endpoints of
post-approval studies; 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, such as Dupixent;
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; unanticipated
expenses; the costs of developing, producing, and selling products;
the ability of Regeneron to meet any of its sales or other
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 relating to Praluent® (alirocumab)
Injection, the ultimate outcome of such litigation, 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 United States Securities and Exchange
Commission, including its Form 10-K for the year ended December 31,
2016 and its Form 10-Q for the quarterly period ended June 30,
2017. 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).
Contacts
Sanofi |
|
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 |
Contacts
Regeneron: |
|
Media Relations
Arleen Goldenberg Tel: +1 (914) 847-3456 Mobile: +1 (914) 260-8788
arleen.goldenberg@regeneron.com |
Investor Relations
Manisha Narasimhan, Ph.D. Tel: 1 (914) 847-5126
Manisha.narasimhan@regeneron.com |
1. American Academy of Allergy Asthma &Immunology.
Eosinophilic Esophagitis (EOE).
http://www.aaaai.org/conditions-and-treatments/related-conditions/eosinophilic-esophagitis.
Accessed Sept 2017. 2. Furuta GT, Katzka DA. Eosinophilic
esophagitis. N Engl J Med. 2015;373(17):1640-1648. 3. Lucendo AJ,
Molina-Infante J, Arias Á, et al. Guidelines on eosinophilic
esophagitis: evidence-based statements and recommendations for
diagnosis and management in children and adults. United European
Gastroenterol J. 2017;5(3):335-358.
Attachments:
http://www.globenewswire.com/NewsRoom/AttachmentNg/b578d7aa-abfa-4bb4-a366-8e561e79a1d5
Sanofi (EU:SAN)
Gráfico Histórico do Ativo
De Mar 2024 até Abr 2024
Sanofi (EU:SAN)
Gráfico Histórico do Ativo
De Abr 2023 até Abr 2024