Second Dupixent® (dupilumab) Phase 3 eosinophilic esophagitis trial
to demonstrate significant disease improvements, underscoring role
of type 2 inflammation in this complex disease
Second
Dupixent®
(dupilumab) Phase 3
eosinophilic
esophagitis
trial to
demonstrate
significant
disease
improvements,
underscoring
role of
type 2
inflammation in
this
complex
disease
- Dupixent 300 mg weekly
significantly improved the ability to swallow and reduced
eosinophils in the esophagus compared to placebo, reinforcing
positive results from first Phase 3 trial
- Dupixent is the first and only
biologic to show positive, clinically meaningful Phase 3 results in
these patients
- Data continue to support
well-established safety profile of Dupixent
- Regulatory filings planned for
2022
PARIS and
TARRYTOWN, N.Y.
– October
25, 2021 –
Results from a second Phase 3 trial assessing the investigational
use of Dupixent® (dupilumab) in patients 12 years and older with
eosinophilic esophagitis (EoE) demonstrated that the trial met its
co-primary endpoints in patients taking Dupixent 300 mg weekly,
showing significant improvements in clinical (Dysphagia Symptom
Questionnaire) and histologic disease measures compared to placebo.
EoE is a chronic and progressive type 2 inflammatory disease that
damages the esophagus and impairs the ability to swallow. In
September 2020, the U.S. Food and Drug Administration (FDA) granted
Breakthrough Therapy designation to Dupixent for the treatment of
patients 12 years and older with EoE.
Results from the extended active treatment
period (up to 52 weeks) of a previously reported Phase 3 trial
studying Dupixent 300 mg weekly for 24 weeks were recently
presented at the United European Gastroenterology Week Virtual 2021
congress. Data from the clinical trial program will be submitted to
regulatory authorities by 2022.
“The current standard of care for people with
eosinophilic esophagitis may only provide limited relief of their
symptoms. Efforts to develop a treatment that targets an underlying
cause of the disease has eluded the field for some time, resulting
in an incredible unmet need,” says Naimish Patel, M.D. Head of
Global Development, Immunology and Inflammation at Sanofi. “We are
encouraged that Dupixent, which targets IL-4 and IL-13, was able to
reduce inflammation in the esophagus and provided significant
relief when swallowing for patients taking the weekly dose. We look
forward to continuing to study Dupixent’s potential role in
addressing the underlying type 2 inflammation that can lead to
eosinophilic esophagitis.”
EoE damages the esophagus and prevents it from
working properly. At times, swallowing the smallest quantity of
food or taking a sip of water can be a painful and worrisome
choking experience. Those with EoE live with anxiety and
frustration from having a constantly evolving list of trigger foods
to avoid. Dilation (physical expansion) of the esophagus, which is
used to address narrowing, is often painful. In severe cases, a
feeding tube is the only option to ensure proper caloric intake and
weight gain. People with EoE may have poor quality of life and are
more likely to experience depression, especially as they age, than
people without EoE. In the U.S., there are approximately 160,000
patients with EoE who are currently treated, of whom approximately
48,000 have failed multiple treatments.
“This trial gives insight into how terrible this
disease can be, with more than a third of patients having
previously required invasive endoscopic dilations that can
temporarily reduce symptoms but carry the risk of rupturing the
esophagus,” says George D. Yancopoulos, M.D., Ph.D., President and
Chief Scientific Officer at Regeneron. “Dupixent, which blocks the
IL-4 and -13 pathways, has now shown compelling results across a
spectrum of diseases where there has been great unmet need. In
fact, our positive Phase 3 data in six different diseases helps
confirm our early hypothesis that interleukin-4 and interleukin-13
are the main drivers of allergic or type 2 inflammation and
disease, whether manifested in the gastrointestinal tract as
eosinophilic esophagitis, the respiratory tract as asthma or nasal
polyps, or the skin as atopic dermatitis, chronic spontaneous
urticaria, or prurigo nodularis.”
In this trial, 80 patients were enrolled into a
Dupixent 300 mg weekly treatment group and 79 patients were
enrolled into a placebo group. The co-primary endpoints at 24 weeks
assessed patient-reported measures of difficulty swallowing (change
from baseline in the Dysphagia Symptom Questionnaire, or DSQ), and
esophageal inflammation (proportion of patients achieving peak
esophageal intraepithelial eosinophil count of ≤6 eos/hpf).
Patients treated with Dupixent 300 mg weekly
experienced the following changes by week 24 compared to
placebo:
- 64% reduction in
disease symptoms from baseline compared to 41% for placebo
(p=0.0008). Dupixent patients experienced a 23.78 point improvement
on the 0-84 DSQ scale, compared to a 13.86 point improvement for
placebo (p<0.0001); baseline DSQ scores were approximately 38
and 36 points, respectively.
- Nearly 10 times
as many Dupixent patients achieved histological disease remission:
59% of patients achieved histological disease remission compared to
6% of placebo patients (p<0.0001). This was measured by the
proportion of patients who achieved a peak esophageal
intraepithelial eosinophil count of ≤6 eos/hpf; mean baseline peak
levels were 89 and 84 eos/hpf, respectively.
Detailed results from the trial will be shared
at an upcoming medical meeting.
The safety results of the trial were generally
consistent with the known safety profile of Dupixent in its
approved indications. For the 24-week treatment period, overall
rates of adverse events were 84% (67/80) for Dupixent 300 mg weekly
and 71% (55/78) for placebo. Adverse events that were more commonly
(≥5%) observed with Dupixent every week included injection site
reactions (38% [30/80] Dupixent, 33% [26/78] placebo), fever (6%
[5/80] Dupixent, 1% [1/78] placebo), sinusitis (5% [4/80] Dupixent,
0% [0/78] placebo), COVID-19 (5% [4/80] Dupixent, 0% [0/78]
placebo) and hypertension (5% [4/80] Dupixent, 1% [1/78] placebo).
No imbalance was observed in rates of treatment discontinuation due
to adverse events between Dupixent (3% [2/80]) and placebo (3%
[2/78]) groups prior to week 24.
Dupixent was granted Orphan Drug designation for
the potential treatment of EoE in 2017. The potential use of
Dupixent in EoE is currently under clinical development, and the
safety and efficacy have not been fully evaluated by any regulatory
authority.
About the Dupixent Eosinophilic
Esophagitis Trial
The Phase 3, randomized, double-blind,
placebo-controlled trial evaluated the efficacy and safety of
Dupixent in adolescents and adults with eosinophilic esophagitis.
The second trial (Part B) enrolled 240 patients aged 12 years and
older with eosinophilic esophagitis, as determined by histological
and patient-reported measures. Following the first Phase 3 trial
(Part A), in which Dupixent 300 mg weekly was evaluated compared to
placebo, the second confirmatory trial evaluated Dupixent 300 mg
weekly or every two weeks compared to placebo for a 24-week
treatment period.
The clinical trial program is ongoing, with
patients from the first and second trials continuing into a 28-week
long-term extension trial (Part C). Full results from this trial
will be available in 2022.
About Dupixent
Dupixent is a fully human monoclonal antibody
that inhibits the signaling of the interleukin-4 (IL-4) and
interleukin-13 (IL-13) pathways and is not an immunosuppressant.
IL-4 and IL-13 are key and central drivers of the type 2
inflammation that plays a major role in atopic dermatitis, asthma
and chronic rhinosinusitis with nasal polyposis (CRSwNP).
Dupixent is currently approved in the U.S.,
Europe, Japan and other countries around the world for use in
specific patients with moderate-to-severe atopic dermatitis, as
well as certain patients with asthma or CRSwNP in different age
populations. Dupixent is also approved in one or more of these
indications in more than 60 countries around the world and more
than 300,000 patients have been treated globally.
Dupilumab Development
Program
Dupilumab is being jointly developed by
Regeneron and Sanofi under a global collaboration agreement. To
date, dupilumab has been studied across 60 clinical trials
involving more than 10,000 patients with various chronic diseases
driven in part by type 2 inflammation.
Sanofi and Regeneron are studying dupilumab in a
broad range of diseases driven by type 2 inflammation or other
allergic processes, including chronic obstructive pulmonary disease
with evidence of type 2 inflammation (Phase 3), pediatric atopic
dermatitis (6 months to 5 years of age, Phase 3), eosinophilic
esophagitis (Phase 3), bullous pemphigoid (Phase 3), prurigo
nodularis (Phase 3), chronic spontaneous urticaria (Phase 3),
chronic inducible urticaria-cold (Phase 3), chronic rhinosinusitis
without nasal polyposis (Phase 3), allergic fungal rhinosinusitis
(Phase 3), allergic bronchopulmonary aspergillosis (Phase 3) and
peanut allergy (Phase 2). These potential uses of dupilumab are
currently under clinical investigation, and the safety and efficacy
in these conditions have not been fully evaluated by any regulatory
authority. Dupilumab is being jointly developed by Sanofi and
Regeneron under a global collaboration agreement.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading
biotechnology company that invents life-transforming medicines for
people with serious diseases. Founded and led for over 30 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to nine
FDA-approved treatments and numerous product candidates in
development, almost all of which were homegrown in our
laboratories. Our medicines and pipeline are designed to help
patients with eye diseases, allergic and inflammatory diseases,
cancer, cardiovascular and metabolic diseases, pain, hematologic
conditions, infectious diseases and rare diseases.
Regeneron is accelerating and improving the
traditional drug development process through our proprietary
VelociSuite® technologies, such as VelocImmune®, which uses unique
genetically humanized mice to produce optimized fully human
antibodies and bispecific antibodies, and through 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 Media Relations
ContactSally BainTel: +1 (781)
264-1091Sally.Bain@sanofi.com
Regeneron Media Relations Contact
Sharon ChenTel: +1 (914)
847-1546sharon.chen@regeneron.com
Investor Relations Contacts
ParisEva Schaefer-JansenArnaud DelepineNathalie Pham
Investor Relations Contact North
AmericaFelix Lauscher
Tel.: +33 (0)1 53 77 45
45investor.relations@sanofi.comhttps://www.sanofi.com/en/investors/contact
Regeneron Investor RelationsVesna TosicTel: +1
(914) 847-5443Vesna.Tosic@regeneron.com
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