Second positive phase III trial for Dupixent ® ( dupilumab ) in the treatment of nodular prurigo , with significant improvements for patients

• Dupixent is the first and only drug with positive Phase III results in the treatment of nodular prurigo, confirming the potential value of targeting interleukins 4 and 13, main factors of type 2 inflammation, to remedy itching and skin lesions.
• The data confirms the results of the first phase III trial with, at 24 weeks, a reduction in itching (primary endpoint) in 60% of patients treated with Dupixent, compared to 18% of patients treated with placebo.
• In addition, a decrease in skin lesions was observed in nearly three times as many patients treated with Dupixent.
• This data continues to strengthen Dupixent's well-established safety profile.
• This data will be submitted to regulatory authorities starting in the first half of this year.
  
  

PARIS and TARRYTOWN (New York) – January 19 , 2022 – A second phase III trial evaluating Dupixent ® ( dupilumab ) in adults with uncontrolled prurigo nodularis, a chronic skin disease with a type 2 inflammatory signature, met its primary endpoint and its main secondary endpoints, and showed a significant reduction in itching and skin lesions compared to placebo, after 24 weeks of experimental treatment. These data confirm the positive results reported previouslyphase III PRIME2 trial and will be submitted to regulatory authorities around the world starting in the first half of this year. The impact of nodular prurigo on quality of life is one of the greatest among inflammatory dermatological diseases, due to the intense itching it causes.

"These results reinforce our knowledge of the biological mechanisms underlying nodular prurigo and are encouraging , as they suggest the possibility of helping patients who are severely affected by the symptoms of this disease, such as intense itching , lesions and the stinging and burning sensations,” said Dr. Naimish Patel, Global Head, Development, Immunology and Inflammation, Sanofi . “  We are committed to further research on type 2 inflammation to advance the s knowledge of several inflammatory dermatological diseases that are still poorly understood. The decision to move directly into phase III for nodular prurigo stems from our belief that type 2 inflammation is a determining factor in this highly pruritic disease and underscores our desire to quickly bring new treatments to patients in need of new therapeutic options are urgently needed. »

Nodular prurigo causes intense and persistent itching and is characterized by thick nodular lesions that can cover the entire surface of the body. Often painful, it causes burning, stinging and tingling sensations on the skin. This disease can have negative repercussions on mental health, activities of daily living and social life. Nodular prurigo is most often treated with very powerful corticosteroids, the long-term use of which carries significant health risks. In the United States, nearly 75,000 people have the condition, fail to control it with topical corticosteroids, and have no other approved treatment options.

"  Nodular prurigo is a very painful disease to bear and can cause several dozen or even several hundred lesions on the skin, accompanied by itching and persistent burning sensations which can sometimes cause complications such as skin infections", specified the Dr. George D. Yancopoulos, Ph.D., President and Chief Scientific Officer of Regeneron. “The results of this trial show once again that Dupixent can significantly address the main symptoms of this disease, with a consistent safety profile and with a numerically lower rate of skin infections. TheThe progress shown by the extensive development program we are devoting to Dupixent is encouraging and confirms the key role played by interleukins 4 and 13 in the type 2 inflammation underlying many diseases , in particular dermatological diseases such as prurigo nodular and atopic dermatitis , respiratory like asthma and nasosinus polyposis , and gastrointestinal like eosinophilic esophagitis. »

In the Phase III PRIME trial, early results from a treatment comparing Dupixent (n=75) to placebo (n=76) showed the following at 24 weeks:

• Almost three times as many Dupixent-treated patients experienced a clinically meaningful reduction in itch from baseline (primary endpoint), 60% of Dupixent-treated patients compared to 18% of placebo-treated patients (p <0.0001).
• Nearly three times as many patients treated with Dupixent experienced complete or near complete healing of their skin (secondary endpoint), i.e. 48% of patients treated with Dupixent compared to 18% of patients treated with placebo (p=0 .0004).
• Improvements in health-related quality of life, skin pain intensity, and symptoms of anxiety and depression were significantly greater in patients treated with Dupixent.
  
  

The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved indications. Over 24 weeks of treatment, the overall rates of treatment-related adverse events were 71% for Dupixent and 63% for placebo. The most common adverse events observed in the Dupixent group were nasopharyngitis (5% for Dupixent, 4% for placebo) and headache (5% for Dupixent, 5% for placebo). In addition, 0% of Dupixent-treated patients and 4% of placebo-treated patients discontinued treatment before week 24 due to adverse events. Similar to the published results of trials dedicated to the treatment of atopic dermatitis,

The details of the results of this trial will be presented at an upcoming medical conference. The potential use of Dupixent for the treatment of nodular prurigo is currently undergoing a clinical development program and no regulatory body has yet evaluated its safety and efficacy profiles in this indication.

About the clinical trial

PRIME, part of the LIBERTY-PN PRIME clinical program, is a Phase III, randomized, double-blind, placebo-controlled clinical trial that evaluated the efficacy and safety of Dupixent in 151 adults with prurigo. nodular disease inadequately controlled by topical medications or for which these medications are not recommended. During the 24-week treatment period, patients were treated with Dupixent or placebo every other week, with or without topical therapy (low or mid-dose topical corticosteroids or topical calcineurin inhibitors were discontinued for patients who were taking this type of treatment at randomisation).

The primary endpoint was the proportion of patients with a clinically meaningful improvement in itch at week 24 (measured by a decrease of at least 4 points on the WI-NRS Worst Itch Numeric Rating Scale ; Numerical Rating of itching intensity ranging from 0-10). A key secondary endpoint was the proportion of patients with complete or near complete healing of their skin at week 24 (measured by a score of 0 or 1 on the IGA PN-S Investigator's Global Assessment for PN-stage; Investigator's global assessment of the stage of nodular prurigo on a scale from 0 to 4).

About Dupixent

Dupixent is a fully human monoclonal antibody that inhibits interleukin 4 (IL-4) and interleukin 13 (IL-13) signaling. Dupixent is not an immunosuppressive drug. Interleukins 4 and 13 are involved in type 2 inflammation which plays a central role in atopic dermatitis, asthma and nasal polyposis.

Dupixent is approved in the United States, Europe, Japan and other countries for the treatment of moderate to severe atopic dermatitis in certain categories of patients, as well as for the treatment of asthma or nasal polyposis. of patients of different ages. Dupixent is approved for one or more of these indications in more than 60 countries. More than 350,000 patients worldwide have been treated with this drug