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Sanofi, Regeneron announce second phase 3 trial of Dupixent to treat prurigo nodularis met primary and key secondary endpoints

Thursday, January 20, 2022, 09:00 Hrs  [IST]

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 US 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.

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).

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 US, 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 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.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health.


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