Sanofi’s pivotal Phase 3 test of Dupixent (dupilumab) to treat moderate-to-severe atopic dermatitis in adolescents met its primary and key secondary endpoints.
Sanofi said Wednesday that, in the trial, treatment with Dupixent as monotherapy significantly improved measures of overall disease severity, skin clearing, itching, and certain health-related quality of life measures. Sanofi noted that Dupixent is the first and only biologic to show positive results in this patient population.
“Moderate-to-severe atopic dermatitis can place a particularly significant burden on adolescents, who have to deal with oozing skin lesions with unrelenting, intense itching during their formative years,” said George D. Yancopoulos, President and Chief Scientific Officer of Regeneron, with whom Sanofi is studying dupilumab in a broad range of clinical development programs. “Dupixent blocks the IL-4/IL-13 pathway, which is emerging as a central driver of Type 2 allergic inflammation. We are committed to investigating the potential for Dupixent across Type 2 inflammatory diseases with high unmet need including atopic dermatitis, asthma, eosinophilic esophagitis, nasal polyps, chronic obstructive pulmonary disease, and food allergy.”
The primary endpoints were the proportion of patients achieving Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) and 75% improvement in Eczema Area and Severity Index (EASI-75, co-primary endpoint outside of the U.S.) at 16 weeks.
Elias Zerhouni, President, Global R&D, Sanofi, said: “Current treatment options for these adolescent patients such as topical steroids, oral steroids, and non-steroidal immunosuppressants can have significant side effects. We continue to explore Dupixent’s role in targeting Type 2 inflammation as an underlying cause of atopic dermatitis to potentially provide adolescents, some of whom have lived with this disease their entire lives, a therapy that treats more than just their symptoms.”