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
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 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.
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Regeneron Forward-Looking Statements and Use of Digital
Media
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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
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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
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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
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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.
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Source: Sanofi via Globenewswire
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