Full Press Release Details
Second positive Phase 3 Dupixent (dupilumab) trial
confirms significant improvements for patients with prurigo nodularis
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:
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.
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
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).
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
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
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.
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.
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.
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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