Dupixent® (dupilumab) late-breaking Phase 3 data presented at
UEG Week 2022 showed significant histological remission of
eosinophilic esophagitis (EoE) in children 1 to 11 years old
- 68% of children
on a higher dose of Dupixent achieved histological disease
remission at week 16
- First and only
Phase 3 trial to show positive results in this patient population;
currently no approved treatments are specifically indicated for
children under 12 years of age with EoE
- Data reinforce
well-established efficacy and safety profile of Dupixent
Paris and Tarrytown, N.Y.
October 11,
2022. Late-breaking positive results from a Phase 3 trial
evaluating the investigational use of Dupixent® (dupilumab) in
children aged 1 to 11 years with active eosinophilic esophagitis
(EoE) will be presented today at United European Gastroenterology
(UEG) Week 2022. The data will be submitted to regulatory
authorities around the world, starting with the U.S. Food and Drug
Administration (FDA) in 2023. In May 2022, Dupixent 300 mg weekly
was approved by the FDA to treat EoE in people aged 12 years and
older, weighing at least 40 kg.
Mirna Chehade,
M.DMount Sinai Center for Eosinophilic Disorders, Icahn
School of Medicine, Mount Sinai“Eosinophilic esophagitis impacts a
child’s fundamental ability to eat, which is especially critical in
early childhood when healthy weight gain is vital to long-term
health and development. These Phase 3 data support the potential of
dupilumab to reduce esophageal damage - caused in part by
underlying type 2 inflammation - and showed histological disease
remission and signs of weight gain impacting the growth percentile
for those children on higher dose Dupixent.”
Dupixent led to significant improvements in the
primary efficacy measure for higher (n=37) and lower (n=31) dose
groups at 16 weeks in the randomized, placebo-controlled Phase 3
trial. Among children treated with Dupixent, 68% of children on
higher dose and 58% of patients on lower dose achieved the primary
endpoint of significant histological disease remission, compared to
3% for placebo (both p<0.0001). Children on the higher dose
regimen also experienced significant improvements in abnormal
endoscopic findings of their esophagus, with a reduction of 3.5
points compared to an increase of 0.3 points for placebo
(p<0.0001). Symptomatically, higher dose Dupixent led to a
numerical improvement in the proportion of days children
experienced disease symptoms from baseline as reported by their
caregivers compared to placebo, though not statistically
significant. Additionally, a prespecified exploratory analysis was
presented which found higher dose Dupixent led to a 3.09 percentile
increase in body weight for age percentile from baseline, compared
to 0.29 for placebo.
Safety results were generally consistent with
the known safety profile of Dupixent in its approved EoE indication
for children and adults aged 12 years and older who weigh at least
40 kg. For the 16-week treatment period, the overall rates of
adverse events (AEs) were 79% (higher dose n=27/37, lower dose
n=26/30) for Dupixent and 91% (n=31/34) for placebo. AEs most
commonly observed with Dupixent (≥5%) compared to placebo included
COVID-19 (higher dose n=5/37, lower dose n=9/30, placebo n=0/34;
all cases were mild or moderate and did not lead to study
discontinuation), rash (higher dose n=3/37, lower dose n=3/30,
placebo n=2/34), headache (higher dose n=1/37, lower dose n=4/30,
placebo n=1/34), viral gastroenteritis (higher dose n=4/37, lower
dose n=0/30, placebo n=1/34), diarrhea (higher dose n=2/37, lower
dose n=2/30, placebo n=1/34) and nausea (higher dose n=1/37, lower
dose n=3/30, placebo n=0/34). Rates of treatment discontinuation
due to AEs prior to week 16 were 0% (higher dose n=0/37, lower dose
n=0/30) for Dupixent and 6% (n=2/34) for placebo.
The potential use of Dupixent in children with
EoE aged 1 to 11 years is currently under clinical development, and
the safety and efficacy have not been evaluated by any regulatory
authority.
About Eosinophilic
Esophagitis
EoE is a chronic inflammatory disease that
damages the esophagus and prevents it from working properly. The
results seen with Dupixent in adults and children with EoE
demonstrate that IL-4 and IL-13 are key and central drivers of the
type 2 inflammation underlying this disease.
In children, common symptoms of EoE include acid
reflux, vomiting, abdominal discomfort, trouble swallowing, and a
failure to thrive. These symptoms can impact growth, weight gain
and development, and can cause food-related fear and anxiety which
can persist through adulthood. Diet adjustments, which oftentimes
include the elimination of many foods, is the standard treatment
for EoE, as well as the use of treatments not approved for the
disease in children. These include proton pump inhibitors,
swallowed topical corticosteroids, or in severe cases, a feeding
tube, which may be used to ensure proper caloric intake and weight
gain.
Of the approximately 21,000 children under the
age of 12 in the U.S. currently being treated for EoE, about 9,000
do not satisfactorily respond to their current treatment regimen
and potentially require advanced therapy.
About the Dupixent Pediatric
Eosinophilic Esophagitis Trial
The Phase 3, randomized, double-blind,
placebo-controlled trial evaluated the efficacy and safety of
Dupixent in young children aged 1 to 11 years with EoE, as
determined by histological, endoscopic and patient- or
caregiver-reported measures. At baseline, 98% of these patients had
at least one co-existing type 2 inflammatory disease such as food
allergy, allergic rhinitis, asthma and atopic dermatitis.
Patients received Dupixent subcutaneously at
either a higher dose or lower dose regimen based on their weight
(ranging from ≥5 kg to <60 kg) over a 16-week period, at which
point all endpoints were assessed. The dosing frequency ranged
between every two weeks and every four weeks, based on weight.
The primary endpoint was histological disease
remission, which was defined as peak esophageal intraepithelial
eosinophil count of ≤6 eosinophils (eos)/high power field (hpf).
Secondary endpoints included abnormal endoscopic findings (EoE
Endoscopic Reference Score [EoE-EREFS] on a 0-18 scale), as well as
changes in caregiver-reported symptoms (proportion of days with 1
or more EoE signs [e.g., stomach pain, vomiting, food refusal] by
the Pediatric EoE Sign/Symptom Questionnaire-caregiver version
[PESQ-C]). The PESQ-C is a novel endpoint developed by Sanofi and
Regeneron used for the first time in this trial, designed to assess
symptoms in young children through their caregivers (as signs), as
children may have difficulty verbalizing their symptoms themselves.
An exploratory endpoint assessed change from baseline in body
weight for age percentile.
The trial is ongoing with a 36-week extended
active treatment period, followed by a 108-week open-label
extension period to evaluate long-term outcomes. These results, as
well as a more detailed lower dose results, will be presented or
published in the future.
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.
The Dupixent development program has shown significant clinical
benefit and a decrease in type 2 inflammation in Phase 3 trials,
establishing that IL-4 and IL-13 are key and central drivers of the
type 2 inflammation that plays a major role in multiple related and
often co-morbid diseases. These diseases include approved
indications for Dupixent such as asthma, atopic dermatitis, chronic
rhinosinusitis with nasal polyposis (CRSwNP), EoE and prurigo
nodularis (PN).
Dupixent has received regulatory approvals in
one or more countries around the world for use in in certain
patients with atopic dermatitis, asthma, CRSwNP, EoE or PN in
different age populations. Dupixent is currently approved across
these indications in the U.S. and for one or more of these
indications in more than 60 countries, including in the European
Union and Japan. More than 500,000 patients have been treated with
Dupixent globally.
Dupilumab Development
Program
Dupilumab is being jointly developed by Sanofi
and Regeneron under a global collaboration agreement. To date,
dupilumab has been studied across more than 60 clinical trials
involving more than 10,000 patients with various chronic diseases
driven in part by type 2 inflammation.
In addition to the currently approved
indications, Sanofi and Regeneron are studying dupilumab in a broad
range of diseases driven by type 2 inflammation or other allergic
processes in Phase 3 trials, including pediatric EoE, hand and foot
atopic dermatitis, chronic inducible urticaria-cold, chronic
spontaneous urticaria, chronic pruritis of unknown origin, chronic
obstructive pulmonary disease with evidence of type 2 inflammation,
chronic rhinosinusitis without nasal polyposis, allergic fungal
rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous
pemphigoid. 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.
About RegeneronRegeneron is a
leading biotechnology company that invents, develops and
commercializes life-transforming medicines for people with serious
diseases. Founded and led for nearly 35 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 more information, please visit
www.Regeneron.com or follow @Regeneron on Twitter.
About SanofiWe are an innovative global healthcare
company, driven by one purpose: we chase the miracles of science to
improve people’s lives. Our team, across some 100 countries, is
dedicated to transforming the practice of medicine by working to
turn the impossible into the possible. We provide potentially
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Sanofi is listed on EURONEXT: SAN and NASDAQ:
SNY.
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