Second positive Phase 3 Dupixent® (dupilumab) trial confirms
significant improvements for patients with prurigo nodularis
Second positive Phase
3 Dupixent®
(dupilumab) trial
confirms significant
improvements for
patients with prurigo
nodularis
- Dupixent is the first and only
medicine to demonstrate positive Phase 3 results in prurigo
nodularis, confirming the potential benefit of targeting IL-4 and
IL-13, central drivers of type 2 inflammation, to address itch and
skin lesions
- Data confirm results from first
Phase 3 trial, with 60% of Dupixent patients meeting the primary
endpoint of itch reduction compared to 18% of placebo at 24
weeks
- Additionally, nearly three times as
many Dupixent patients experienced reduced skin lesions
- Data continue to support
well-established safety profile of Dupixent
- Data to be submitted to regulatory
authorities starting in H1
PARIS and
TARRYTOWN, N.Y.
– January 19,
2022 – A second Phase 3 trial
evaluating Dupixent® (dupilumab) in adults with uncontrolled
prurigo nodularis, a chronic type 2 inflammatory skin disease, met
its primary and key secondary endpoints, showing it significantly
reduced itch and skin lesions compared to placebo at 24 weeks in
this investigational setting. The data confirm the positive results
that were previously reported from the Phase 3 PRIME2 trial and
will be submitted to regulatory authorities around the world
starting in the first half of this year. The impact of prurigo
nodularis on quality of life is one of the highest among
inflammatory skin diseases due to the extreme itch.
“These results strengthen our understanding of
the underlying biology of prurigo nodularis and are encouraging as
we seek to help patients severely impacted by symptoms like
unbearable itch, skin lesions, stinging and burning,” says Naimish
Patel, M.D, Head of Global Development, Immunology and Inflammation
at Sanofi. “We are committed to researching the science behind type
2 inflammation to advance and shift perceptions in a number of
inflammatory skin diseases that are not well-understood. The
decision to accelerate directly into a Phase 3 clinical trial for
prurigo nodularis was driven by our conviction that type 2
inflammation is a key driver of this highly pruritic disease and
underscores our commitment to quickly bring novel treatments to
patients who are in urgent need of new options.”
People with prurigo nodularis can experience
intense, persistent itch, with thick skin lesions (called nodules)
that can cover most of the body. It is often described as painful
with burning, stinging and tingling of the skin. The disease can
also negatively affect mental health, activities of daily living
and social interactions. High-potency topical steroids are commonly
prescribed but are associated with safety risks if used long-term.
There are approximately 75,000 people in the U.S. who are unable to
control their disease with topical steroids and otherwise do not
have an approved treatment option.
“Prurigo nodularis is a highly burdensome
disease involving dozens, if not hundreds of incessantly itchy and
burning skin lesions, and the potential for complications such as
skin infections,” said George D. Yancopoulos, M.D., Ph.D.,
President and Chief Scientific Officer at Regeneron. “The results
of this trial once again show that Dupixent is able to
significantly address the hallmark symptoms of this disease while
maintaining a consistent safety profile, including a numerically
lower rate of skin infections. We are encouraged by the progress of
our extensive Dupixent development program that continually
reinforces IL-4 and IL-13 as key drivers of the type 2 inflammation
underlying a number of diseases, including dermatological diseases
such as prurigo nodularis and atopic dermatitis, respiratory
diseases such as asthma and CRSwNP, and gastrointestinal diseases
such as eosinophilic esophagitis.”
In the Phase 3 PRIME trial, topline results
comparing Dupixent (n=75) to placebo (n=76) showed at week 24:
- More than three times as many
Dupixent patients experienced a clinically meaningful reduction in
itch from baseline, the primary endpoint: 60% of Dupixent patients
compared to 18% of placebo patients (p <0.0001).
- Nearly three times as many Dupixent
patients achieved clear or almost clear skin, a secondary endpoint:
48% of Dupixent patients compared to 18% of placebo patients (p=
0.0004).
- Dupixent
patients experienced significantly greater improvements in measures
of overall health-related quality of life, skin pain, and symptoms
of anxiety and depression.
The safety results of the trial were consistent
what was observed in PRIME2 and were also generally consistent with
the known safety profile of Dupixent in its approved indications.
For the 24-week treatment period, overall rates of
treatment-emergent adverse events were 71% for Dupixent and 63% for
placebo. Adverse events most commonly observed with Dupixent
included nasopharyngitis (5% Dupixent, 4% placebo) and headache (5%
Dupixent, 5% placebo). Additionally, 0% of Dupixent patients and 4%
of placebo patients discontinued treatment due to adverse events
prior to week 24. Consistent with published literature for the
atopic dermatitis trials, numerically lower rates of skin
infections were seen with Dupixent in this trial (4% Dupixent, 9%
placebo).
Detailed results from this trial will be
presented at an upcoming medical congress. The potential use of
Dupixent in prurigo nodularis is currently under clinical
development and the safety and efficacy have not been fully
evaluated by any regulatory authority.
About the Trial
PRIME, part of the LIBERTY-PN PRIME clinical
program, is a randomized, Phase 3, double-blind, placebo-controlled
trial that evaluated the efficacy and safety of Dupixent in 151
adults with prurigo nodularis inadequately controlled with topical
prescription therapies or with whom those therapies were not
advisable. During the 24-week treatment period, patients received
Dupixent or placebo every two weeks with or without topical
treatments (low- or medium-dose topical corticosteroids or topical
calcineurin inhibitors were continued if patients were using these
treatments at randomization).
The primary endpoint evaluated the proportion of
patients with clinically meaningful improvement in itch at 24 weeks
(measured by a ≥4-point reduction in Worst-Itch Numeric Rating
Scale [WI-NRS] of 0-10). A key secondary endpoint was the
proportion of patients with clear or almost clear skin at 24 weeks
(measured by a score of 0 or 1 on the Investigator's Global
Assessment PN-Stage [IGA PN-S] 0-4 scale).
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 350,000 patients have been treated 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 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, including prurigo nodularis (Phase 3), 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), 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.
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.
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