Press Release: Dupixent® (dupilumab) Phase 3 Results show sustained
efficacy for up to one year in children 1 to 11 years of age with
eosinophilic esophagitis (EoE)
Dupixent® (dupilumab) Phase 3 Results show
sustained efficacy for up to one year in children 1 to 11 years of
age with eosinophilic esophagitis (EoE)
- Late-breaking presentation at ACG 2023
showed histologic and endoscopic improvements were maintained with
no new safety signals to week 52 with higher dose Dupixent in these
children
- Data reinforce the role of type 2
inflammation in EoE and the importance of targeting both IL-4 and
IL-13 pathways
- sBLA for Dupixent to treat children
aged 1 to 11 years with EoE is under Priority Review in the U.S.;
if approved, Dupixent would be the first and only FDA-approved
treatment for these children with EoE
Paris and Tarrytown, N.Y. October 22,
2023. Positive results from a Phase 3 trial demonstrated
the efficacy and safety profile of Dupixent® (dupilumab) for up to
one year (52 weeks) in children aged 1 to 11 years with
eosinophilic esophagitis (EoE) was consistent. These results
represent the first analysis of longer-term data in this age group
and will be featured in a late-breaking session on October 25 at
the American College of Gastroenterology (ACG) 2023 Annual
Scientific Meeting.
Mirna Chehade, M.D.,
MPH Mount Sinai Center for Eosinophilic Disorders,
Icahn School of Medicine, Mount Sinai “Eosinophilic
esophagitis, or EoE, is a chronic and debilitating condition that
can impact children in their most vulnerable years of life, causing
persistent difficulties with eating, abdominal pain, and/or failure
to thrive. Dupilumab is the first and only therapeutic approved for
adults and adolescents 12 years and older who weigh at least 40 kg
with EoE. Some children with EoE may have sub-optimal response to
currently unapproved standard of care therapies, underscoring the
need for treatments targeting key pathways driving inflammation in
EoE. Data from this Phase 3 trial support the potential of
dupilumab to treat EoE in children, with sustained efficacy and
safety, which is particularly critical for these children.”
The late-breaking data to be presented at ACG
feature results from children enrolled in the extended active
treatment period (Part B) of a Phase 3 trial, following 16 weeks of
Dupixent treatment or placebo in Part A of the trial. All children
in Part B were treated with higher or lower dose Dupixent for an
additional 36 weeks, providing up to 52 weeks of data.
In Part B, there were 37 patients who continued
on higher dose Dupixent and 18 who switched from placebo to higher
dose Dupixent. At one year, outcomes of secondary endpoints (as
evaluated with descriptive statistics based on all observed data)
among children who continued on higher dose Dupixent and for those
switching from placebo to higher dose Dupixent was, respectively,
as follows:
- 63% and 53% achieved histological
disease remission
- 0.97 and 0.89 reduction from baseline
in disease severity and 0.89 and 0.86 reduction from baseline in
extent, respectively, as measured at the microscopic level in
biopsy specimens
- 4.8 and 3.6-point reduction in
abnormal endoscopic findings from baseline
- 0.30 and 0.47-point numerical
improvement in caregiver reported pediatric signs and symptoms, as
measured by PESQ-C
- 5.96 and 5.48 percentile increase in
body weight for age percentile from baseline
Safety results in Part B of the trial were
generally consistent with Part A and the known safety profile of
Dupixent in its FDA-approved EoE indication for adult and
adolescent patients aged 12 years and older who weigh at least 40
kg. AEs reported in ≥20% of patients who remained on higher dose
Dupixent in Part B and those who switched from placebo to higher
dose Dupixent in Part B, respectively, included: COVID-19 (n=11/37,
n=5/18; all cases were mild or moderate and did not lead to study
treatment discontinuation), injection site reaction (n=5/37,
n=5/18), cough (n=3/37, n=4/18) and headache (n=3/37, n=4/18).
In September, the U.S. Food and Drug
Administration accepted for Priority Review the supplemental
Biologics License Application for higher dose Dupixent to treat
children aged 1 to 11 years with EoE, with a target action
date of January 31, 2024. This potential use of Dupixent in
children with EoE aged 1 to 11 years is currently under clinical
development, and its safety and efficacy have not been fully
evaluated by any regulatory authority in this setting.
About Eosinophilic
EsophagitisEoE is a chronic, progressive disease driven in
part by type 2 inflammation that damages the esophagus and prevents
it from working properly. In children, common symptoms of EoE
include heartburn, vomiting, abdominal discomfort, trouble
swallowing, food refusal and failure to thrive. These symptoms can
impact growth and development and can cause food-related fear and
anxiety, which can persist through adulthood. Dietary adjustments,
which oftentimes include the elimination of food groups, are the
standard treatment for EoE, as well as the use of treatments not
approved for the disease, such as proton pump inhibitors and
swallowed topical corticosteroids. Continuous treatment of EoE may
be needed to reduce the risk of complications and disease
recurrence.
About the Dupixent Pediatric Eosinophilic
Esophagitis Trial The Phase 3, randomized, double-blind,
placebo-controlled trial evaluated the efficacy and safety of
Dupixent in 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.
Part A, a 16-week, double-blind treatment period,
enrolled 102 patients and evaluated Dupixent subcutaneously at
either a higher dose or lower dose regimen based on weight (ranging
from ≥5 kg to <60 kg). 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).
Part B was a 36-week extended active treatment
period in which eligible children from Part A in the Dupixent group
maintained their dose level; those in the placebo group were
randomized to either a higher or lower dose. In Part B, secondary
endpoints included:
- Histological disease remission (peak
esophageal intraepithelial eosinophil count of ≤6 eosinophils
[eos]/high power field [hpf])
- Histopathologic measures of the
severity and extent of tissue scarring in the esophagus (EoE-HSS
grade and stage scores, which measure changes in eight cellular and
tissue features on 0-3 scales, respectively)
- Abnormal endoscopic findings (EoE
Endoscopic Reference Score [EoE-EREFS] on a 0-18 scale)
- 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])
- Change from baseline in body weight
for age percentile
The trial is ongoing with a 108-week open-label
extension period (Part C) to evaluate longer-term outcomes.
About DupixentDupixent is a fully
human monoclonal antibody that inhibits the signaling of the IL-4
and 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 atopic dermatitis, asthma, chronic rhinosinusitis
with nasal polyposis (CRSwNP), prurigo nodularis and EoE.
Dupixent has received regulatory approvals in one
or more countries around the world for use in certain patients with
atopic dermatitis, asthma, CRSwNP, EoE or prurigo nodularis in
different age populations. Dupixent is currently approved for one
or more of these indications in more than 60 countries, including
in Europe, the U.S. and Japan. More than
750,000 patients are being treated with Dupixent globally.
Dupilumab Development
ProgramDupilumab 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,
Regeneron and Sanofi 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, chronic pruritus of
unknown origin, chronic obstructive pulmonary disease with evidence
of type 2 inflammation 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 Regeneron Regeneron is a
leading biotechnology company that invents, develops, and
commercializes life- transforming medicines for people with serious
diseases. Founded and led for 35 years by physician-scientists,
Regeneron's unique ability to repeatedly and consistently translate
science into medicine has led to numerous FDA-approved treatments
and product candidates in development, almost all of which were
homegrown in Regeneron's laboratories. Regeneron's medicines and
pipeline are designed to help patients with eye diseases, allergic
and inflammatory diseases, cancer, cardiovascular and metabolic
diseases, hematologic conditions, infectious diseases, and rare
diseases.
Regeneron is accelerating and improving the
traditional drug development process through its 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 Regeneron, please
visit www.regeneron.com or follow Regeneron on LinkedIn.
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
life-changing treatment options and life-saving vaccine protection
to millions of people globally, while putting sustainability and
social responsibility at the center of our ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ:
SNY
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