Sanofi, Regeneron: Dupilumab Hits Main Objectives in Late-Stage Asthma Trial
(Thomson Reuters ONE) -
Sanofi and Regeneron Announce Positive Dupilumab Topline Results From Phase 3
Trial in Uncontrolled Persistent Asthma
- Investigational dupilumab reduced severe asthma attacks and improved lung
function -
Paris, France and Tarrytown, New York - September 11, 2017 - Sanofi and
Regeneron Pharmaceuticals, Inc. today announced that the pivotal Phase 3 LIBERTY
ASTHMA QUEST study of dupilumab in a broad population of patients with
uncontrolled, persistent asthma met its two primary endpoints.
Dupilumab, when added to standard therapies, reduced severe asthma attacks
(exacerbations) and improved lung function. At 52 weeks, in the 300 mg dose
group, dupilumab reduced severe asthma attacks by 46 percent in the overall
population, 60 percent in patients with 150 eosinophilic cells/microliter or
greater, and 67 percent in patients with 300 eosinophilic cells/microliter or
greater (p less than 0.001 for all groups). At 12 weeks, in the 300 mg dupilumab
dose group, mean improvement in lung function over placebo as assessed by forced
expiratory volume over one second (FEV(1)) with dupilumab was 130 mL (9 percent)
in the overall population, 210 mL (11 percent) in patients with 150 eosinophilic
cells/microliter or greater, and 240 mL (18 percent) in patients with 300
eosinophilic cells/microliter or greater (p less than 0.001 for all groups).
The companies plan to submit a Supplemental Biologics License Application (sBLA)
to the U.S. Food and Drug Administration (FDA) by the end of this year.
"Approximately one million U.S. adults and adolescents live with uncontrolled,
persistent asthma, and continue to experience serious asthma attacks, despite
taking an intensive regimen of standard therapies," said George D. Yancopoulos,
M.D., Ph.D., President and Chief Scientific Officer of Regeneron. "Dupilumab has
now demonstrated positive late-stage results in two serious allergic diseases --
asthma and atopic dermatitis -- with robust efficacy and an extensive safety
database. These results continue to support our hypothesis that the IL4/IL13
pathway is a critical driver of allergic disease, and we remain committed to
further investigating the IL-4/IL-13 pathway in other allergic diseases."
The results for the 200 mg and 300 mg dupilumab dose groups were generally
comparable on both exacerbations and FEV(1). The extent of patient response
correlated with allergic or atopic status as reflected by blood eosinophils and
other markers. Less activity was observed in patients with less than 150
eosinophilic cells/microliter. The overall rates of adverse events, deaths,
infections, conjunctivitis, herpes and discontinuations were comparable between
the dupilumab and placebo groups. Injection site reactions were more common in
the dupilumab groups occurring in 17 percent of dupilumab patients compared to
8 percent of placebo patients.
"We believe that therapies like dupilumab, which focus on specific molecular
pathways such as the Th2 pathway associated with multiple chronic allergic
diseases, are important targets for further investigation," said Elias Zerhouni,
M.D., President, Global R&D, Sanofi. "The positive data from this large second
pivotal trial in uncontrolled persistent asthma, following the positive results
of dupilumab in atopic dermatitis, further support this view in our opinion. We
will work diligently with health authorities to bring this new application of
dupilumab to the patients who most need it."
The QUEST pivotal Phase 3 trial enrolled 1,902 patients including 1,795 adults
and 107 adolescents across 413 study sites worldwide. The four study groups
included patients treated with 200 mg every other week with a loading dose of
400 mg, 300 mg every other week with a loading dose of 600 mg, and two separate
placebo groups. Patients were randomized in a 2:1 fashion to active drug versus
placebo. The two primary endpoints of the study were the annualized rate of
severe exacerbation events at 52 weeks and the absolute change from baseline in
a standard measure of lung function known as pre-bronchodilator forced
expiratory volume over one second (FEV(1)) at 12 weeks (changes of 100 to 200 mL
are considered clinically relevant). The pre-specified primary analysis included
hierarchical evaluation of these endpoints in the overall population, in
patients with 150 eosinophilic cells/microliter or greater, and in patients with
300 eosinophilic cells/microliter or greater. In the study, approximately 50
percent of patients had 300 eosinophilic cells/microliter or greater and
approximately 70 percent of patients had 150 eosinophilic cells/microliter or
greater. Higher eosinophil counts are generally thought to be associated with
poorer asthma control and higher rates of exacerbations, as was observed in the
placebo patients in this study.
All patients continued on a medium or high dose inhaled corticosteroid (ICS) and
up to two additional controller medicines throughout the study. Eosinophil
subgroups were classified based on baseline levels.
Detailed results from this study will be submitted for presentation at a future
medical congress. QUEST is the second pivotal trial in uncontrolled persistent
asthma following a positive Phase 2b pivotal study of dupilumab. Data from
another Phase 3 study known as VENTURE examining the ability of dupilumab to
reduce oral corticosteroid use in patients with severe steroid-dependent asthma
are expected later this year. Also included in the LIBERTY ASTHMA clinical
development program is the TRAVERSE trial, a long-term safety extension study.
The potential use of dupilumab in asthma is currently under clinical development
and the safety and efficacy have not been fully evaluated by any regulatory
authority.
In March 2017, the FDA approved Dupixent® (dupilumab) in the U.S. for the
treatment of moderate-to-severe atopic dermatitis that is not adequately
controlled with topical prescription therapies.
About Uncontrolled Persistent Asthma
People who live with uncontrolled persistent asthma often have severe attacks
(exacerbations) that may lead to emergency room visits, hospitalizations and
decreased lung function. Despite currently available treatments, there is a need
for new medicines that offer comprehensive asthma control including preservation
of lung function and reduction in exacerbations.([i],[ii]) Uncontrolled
persistent asthma is often associated with other Type 2 allergic inflammatory
diseases including atopic dermatitis, nasal polyps, allergic rhinitis,
eosinophilic esophagitis and food allergies. The disease is characterized by an
imbalance or overactivity of certain immune cells (including eosinophils) and
signaling proteins known as interleukins. Two of these are Interleukin-4 (IL-4)
and interleukin-13 (IL-13)( 1-)(,[iii],[iv],)[v], which are central drivers of
Type 2 inflammation.
About Dupilumab Clinical Programs
Dupilumab is a fully 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 allergic 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) nasal polyps (Phase 3) and eosinophilic esophagitis (Phase
2). 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.
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.
For more information on dupilumab clinical trials please visit
www.clinicaltrials.gov.
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 consistently
translate science into medicine has led to six FDA-approved treatments and over
a dozen product candidates, 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, infectious diseases
and rare diseases.
Regeneron is accelerating and improving the traditional drug development process
through its proprietary VelociSuite® technologies, including VelocImmune® which
yields optimized fully-human antibodies, 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 (at)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
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development, including future clinical data and analysis of existing clinical
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Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for
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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,"
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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 uncontrolled, persistent asthma in adults and adolescents
and other potential indications; 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
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the relevant endpoints of post-approval studies; determinations by regulatory
and administrative governmental authorities which may delay or restrict
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and product candidates, such as Dupixent; competing drugs and product candidates
that may be superior to Regeneron's products and product candidates; uncertainty
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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 permanent injunction granted by the United States
District Court for the District of Delaware that, if upheld on appeal, would
prohibit Regeneron and Sanofi from marketing, selling, or manufacturing Praluent
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Regeneron uses its media and investor relations website and social media outlets
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Contacts Sanofi:
Media Relations Investor Relations
Ashleigh Koss George Grofik
Tel: 908-981-8745 Tel: +33 (0) 1 53 77 94 69
ashleigh.koss(at)sanofi.com ir(at)sanofi.com
U.S. Communications
Carrie Brown
Tel: +1 (908) 981-6486
Mobile: +1 (908) 247-6006
Carrie.Brown(at)sanofi.com
Contacts Regeneron:
Media Relations Investor Relations
Ilana Tabak Manisha Narasimhan, Ph.D.
Tel: + 1 (914) 847-3836 Tel: +1 (914) 847-5126
Mobile: +1 (914) 450-6677 Manisha.narasimhan(at)regeneron.com
ilana.tabak(at)regeneron.com
###
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[i] Bjermer L. Time for a paradigm shift in asthma treatment: From relieving
bronchospasm to controlling systemic inflammation. J Allergy Clin Immunol.
2007;120(6):1269-1275.
[ii] Global Initiative for Asthma. Global Strategy for Asthma Management and
Prevention. 2015.
[iii] Fulkerson PC, Rathenberg ME. Targeting eosinophils in allergy,
inflammation and beyond. Nat Rev Drug Discov. 2013;12(2)1-23.
[iv] Caruso M, Crisafulli E, Lizzio R, Polosa R. Biologic therapy for atopic
asthma and beyond. Curr Opin Allergy Clin Immunol. 2013;13(6):677-685.
[v] Platts-Mills TAE, Adachi M, Busse WW, Holgate ST. Asthma. In: Holgate ST,
Church MK, Broide DH, Martinez FD, eds. Allergy. 4th ed. Edinburgh, UK: Elsevier
Saunders; 2012:181-202.
Press Release:
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Source: Sanofi via GlobeNewswire
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Datum: 11.09.2017 - 06:58 Uhr
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