TARRYTOWN, N.Y. and
PARIS, Oct.
16, 2017 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi 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.[2]
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 either dupilumab 300 mg weekly following a
600 mg loading dose or placebo. At week 10, patients who received
dupilumab 300 mg weekly reported a significant improvement in the
ability to swallow with a three point reduction in their SDI score
(45 percent improvement) compared to 1.3 points (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 points
from baseline (48 percent improvement) in patients who received
dupilumab weekly compared to 0.3 points (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 for moderate-to-severe atopic
dermatitis in adults and has demonstrated clinical activity in
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 patients'
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 Dupilumab
Dupixent® (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 was discovered using Regeneron's proprietary
VelocImmune® technology that yields optimized
fully-human antibodies and 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 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 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
|
Investor
Relations
|
Ashleigh
Koss
|
George
Grofik
|
Tel: +1 (908) 981
8745
|
Tel: +33 (0)1 53 77
45 45
|
ashleigh.koss@sanofi.com
|
ir@sanofi.com
|
|
|
Contacts
Regeneron:
|
|
|
|
Media
Relations
|
Investor
Relations
|
Arleen
Goldenberg
|
Manisha Narasimhan,
Ph.D.
|
Tel: +1 (914)
847-3456
|
Tel: +1 (914)
847-5126
|
Mobile: +1 (914)
260-8788
|
Manisha.narasimhan@regeneron.com
|
arleen.goldenberg@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] Wechsler, JB, Bryce, PJ. Allergic Mechanisms in
Eosinophilic Esophagitis. Gastroenterology Clinics of North America. 2014; 43(2): 281-296.
View original
content:http://www.prnewswire.com/news-releases/regeneron-and-sanofi-announce-positive-phase-2-study-results-for-dupilumab-in-patients-with-active-moderate-to-severe-eosinophilic-esophagitis-300536933.html
SOURCE Regeneron Pharmaceuticals, Inc.