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Sanofi and Regeneron’s Dupixent receives second positive phase 3 trial results

The trial confirms the potential benefit of targeting inflammation in prurigo nodularis


The latest news from Sanofi Genzyme and Regeneron Pharmaceuticals shared positive results from the second phase 3 for Dupixent (dupilumab), a medicine the companies developed to target chronic inflammatory skin diseases.

Dupixent is a jointly developed medicine, as part of Sanofi and Regeneron’s global collaboration agreement, and is a treatment that to date has been studied across 60 clinical trials involving over 10,000 patients living with various chronic conditions, specifically those suffering with type 2 inflammation.

For patients diagnosed with prurigo nodularis, persistent itching, burning and stinging of the skin results in thick skin lesions or nodules that can cover the body. Patients living with the chronic condition have reported the negative impact it can have on mental health and day-to-day living. A common prescription for the condition is a course of highly potent topical steroids which carry certain safety risks if used for a long-term treatment period.

The second phase 3 trial evaluating Dupixent involved adult patients diagnosed with uncontrolled prurigo nodularis – a chronic type 2 inflammatory skin disease – and met its primary and secondary endpoints.

The results demonstrated that the treatment significantly reduced skin lesions and itching versus placebo treatment at 24 weeks. The positive results back up those gathered from the data previously reported from the phase 3 PRIME2 trial and will be submitted for regulatory approval worldwide during the first half of 2022.

The PRIME trial – a branch of the LIBERTY-PN PRIME clinical programme – is a randomised, phase 3, double-blind, placebo-controlled evaluation, investigating the effectiveness and safety of Dupixent in 151 adult patients with prurigo nodularis.

These patients have either been ineligible for topical prescription therapies or have found that topical therapies have provided inadequate control for their condition. Throughout the 24-week trial period, patients were administered Dupixent or placebo every two week, with or without topical treatments.

Sanofi’s head of global development, immunology and inflammation, Naimish Patel, commented: “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.”

George Yancopoulos, president and chief scientific officer at Regeneron, said: “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 programme 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.”

Presently, Dupixent is approved in Europe, the US, Japan and other countries worldwide for use in specific patients with moderate-to-severe atopic dermatitis, as well as certain patients with asthma or chronic rhinosinusitis (CRSwNP) with nasal polyps in different age populations. A detailed evaluation of the results from the latest trial are due to be presented at an upcoming medical congress.

Article by
Fleur Jeffries

20th January 2022

From: Healthcare



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