Dupixent® (dupilumab) eosinophilic esophagitis trial meets both
co-primary endpoints
Dupixent® (dupilumab) eosinophilic esophagitis trial
meets both co-primary endpoints
- Dupixent demonstrated significant clinical and anatomic
improvements, including the ability to swallow, in Part A of
pivotal trial
- 69% reduction in disease symptoms with Dupixent, compared to
32% for placebo (p=0.0002)
- There are currently no FDA-approved treatments for eosinophilic
esophagitis, a condition that impacts patients’ ability to eat
PARIS and TARRYTOWN, N.Y. - May 22, 2020
– Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ:
REGN) today announced positive results from Part A of the pivotal
Phase 3 trial evaluating Dupixent® (dupilumab) in patients 12 years
and older with eosinophilic esophagitis (EoE). The trial met both
of its co-primary endpoints, as well as all key secondary
endpoints. Dupixent is the first and only biologic to show positive
and clinically-meaningful results in this population as part of a
Phase 3 trial. An ongoing Part B portion of the Phase 3 trial
evaluates an additional Dupixent dosing regimen.
EoE is a chronic and progressive type 2
inflammatory disease that damages the esophagus and prevents it
from working properly, leading to difficulties swallowing. If
untreated, symptoms and inflammation can progress, causing
functional damage and scarring of the esophagus. EoE can lead to
esophageal food impaction, requiring immediate emergency room
visits. Almost half of the patients in this trial had prior
procedures such as dilation of their esophagus, and almost
three-quarters had previously been treated with corticosteroids. In
the U.S., there are approximately 160,000 patients with EoE who are
currently treated, of which an estimated 50,000 have failed
multiple treatments.There are currently no therapies approved by
the U.S. Food and Drug Administration (FDA).
“Eosinophilic esophagitis can be debilitating,
and there are no approved treatment options. It impacts patients’
ability to eat, causes severe pain and often results in repeated
emergency room visits and medical procedures,” said George D.
Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief
Scientific Officer of Regeneron. “These data are particularly
impressive as Dupixent not only dramatically reduced eosinophils in
the esophagus, but also improved all clinical, anatomic and
histologic measures of the disease. In the past, EoE was thought to
be a disease caused by eosinophils, but other biologics that
decrease the eosinophils in the esophagus did not demonstrate
consistent clinical or anatomical improvements. These Dupixent
results demonstrate EoE is caused by multiple aspects of type 2
inflammation, driven by interleukin-4 and interleukin-13. EoE is
the fourth atopic or type 2 inflammatory disease in which Dupixent
has pivotal data demonstrating significant efficacy.”'
“These data demonstrate Dupixent’s potential to
continue to address treatment gaps across the spectrum of type 2
inflammatory diseases as common as asthma and as rare as
eosinophilic esophagitis,” said John Reed, M.D, Ph.D, Global Head
of Research and Development at Sanofi. “For the first time in a
Phase 3 trial, patients reported an improvement in their ability to
swallow food. For patients with eosinophilic esophagitis who are
living with restricted diets and, in some cases, repeated hospital
interventions, these findings are encouraging.”
Part A of the trial enrolled 81 patients (42
with Dupixent, 39 with placebo) aged 12 years and older with EoE,
as determined by histological and patient-reported measures. The
co-primary endpoints assessed the change from baseline in the
Dysphagia Symptom Questionnaire (DSQ), a patient-reported measure
of difficulty swallowing, and the proportion of patients achieving
peak esophageal intraepithelial eosinophil count of ≤6 eos/hpf, a
measure of an esophageal inflammation, at 24 weeks.
Patients treated with Dupixent 300 mg weekly
experienced the following changes by week 24 from baseline:
- 69% reduction in disease symptoms compared to 32% for placebo
(p=0.0002). Disease symptoms were measured by the DSQ scale, where
patients experienced a 21.92 point improvement with Dupixent
compared to a 9.60 point improvement for placebo, on a 0-84 scale
(p=0.0004), the co-primary endpoint; baseline DSQ scores were
approximately 34 points.
- 60% reduction in their esophageal eosinophilic count to a
normal range compared to 5% for placebo (p<0.0001), the
co-primary endpoint. This was measured by the proportion of
patients who achieved a peak esophageal intraepithelial eosinophil
count of ≤6 eos/hpf (a normal range); mean baseline peak levels
were 89 eos/hpf.
- 39% reduction in abnormal endoscopic findings, compared to 0.6%
worsening for placebo. This was measured by the EoE Endoscopic
Reference Score (EoE-EREFS), where patients experienced a 3.2 point
reduction with Dupixent compared to a 0.3 point reduction for
placebo (p<0.0001).
The trial demonstrated similar safety results to
the known safety profile of Dupixent in its approved indications.
For the 24-week treatment period, overall rates of adverse events
were 86% for Dupixent and 82% for placebo. Adverse events that were
more commonly observed with Dupixent included injection site
reactions (n=15 for Dupixent and n=12 for placebo) and upper
respiratory-tract infections (n=11 for Dupixent and n=6 for
placebo). There was one treatment discontinuation in
the Dupixent group due to arthralgia.
Detailed results from this trial will be
presented at an upcoming medical meeting. Dupixent received Orphan
Drug Designation from the FDA in 2017 for the potential treatment
of EoE. This status is given to investigational medicines intended
for the safe and effective treatment of rare diseases that affect
fewer than 200,000 people in the U.S. The potential use of Dupixent
in eosinophilic esophagitis is currently under clinical
development, and the safety and efficacy have not been evaluated by
any regulatory authority.
Dupixent is a fully-human monoclonal antibody
that inhibits the signaling of the interleukin-4 (IL-4) and
interleukin-13 (IL-13) proteins. Data from Dupixent clinical trials
have shown that IL-4 and IL-13 are key drivers of the type 2
inflammation that plays a major role in atopic dermatitis, asthma,
chronic rhinosinusitis with nasal polyposis and eosinophilic
esophagitis.
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.
Part A of the trial enrolled 81 patients aged 12 years and older
with eosinophilic esophagitis, as determined by histological and
patient-reported measures. In total, 85% of these patients suffered
from at least one concurrent atopic condition such as allergic
rhinitis, food allergy and asthma. Patients received weekly
subcutaneous injections of Dupixent 300 mg or placebo for the
24-week treatment period.
The trial is ongoing, with additional patients
enrolling in Part B as well as patients continuing in a 28-week
extended active treatment period (Part C).
Dupilumab Development ProgramIn
addition to the currently approved indications, Sanofi and
Regeneron are also studying dupilumab in a broad range of clinical
development programs for diseases driven by allergic and other type
2 inflammation, including pediatric asthma (6 to 11 years of age,
Phase 3), pediatric atopic dermatitis (6 months to 5 years of age,
Phase 2/3), chronic obstructive pulmonary disease (Phase 3),
bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3), chronic
spontaneous urticaria (Phase 3), and food and environmental
allergies (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 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 seven FDA-approved treatments and numerous
product candidates in development, 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, 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, Empowering Life |
Sanofi
Media Relations Ashleigh KossTel: +1 (908)
981-8745Ashleigh.Koss@sanofi.com |
Sanofi
Investor Relations Felix Lauscher Tel.: +33 (0)1 53 77 45
45 ir@sanofi.com |
Regeneron
Media RelationsSharon ChenTel: +1 (914)
847-1546Sharon.Chen@regeneron.com |
Regeneron
Investor RelationsMark HudsonTel: +1 (914)
847-3482Mark.Hudson@regeneron.com |
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