Regeneron, Sanofi: Dupixent Phase 3 Atopic Dermatitis Studies Meet Primary Goal

(RTTNews) - Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi (SNYNF, SNY) announced Saturday that their two placebo-controlled Phase 3 studies evaluating investigational Dupixent in adult patients with inadequately controlled moderate-to-severe atopic dermatitis met their primary endpoints.

The LIBERTY AD SOLO 1 and SOLO 2 studies met their primary endpoints evaluating the extent and severity of the disease.

In addition, both trials met key secondary endpoints measuring reduction in itch, improvement in patient-reported anxiety and depression symptoms, and certain quality of life measures.

The detailed results were published in the New England Journal of Medicine or NEJM.

The companies noted that Dupixent inhibits signaling of IL-4 and IL-13, two key cytokines required for the type 2 (including Th2) immune response, which is believed to be a major driver in AD, and certain atopic or allergic diseases including asthma and nasal polyposis, where Dupixent is being evaluated in ongoing clinical studies.

Eric Simpson, lead author of the NEJM paper, said, "These results support the growing body of evidence for Dupixent as a potential new treatment option for patients with moderate-to-severe atopic dermatitis who are struggling to control their disease. The Phase 3 SOLO 1 and SOLO 2 clinical trials are the first large pivotal studies where a systemic investigational therapy has demonstrated a significant reduction in the signs and symptoms of atopic dermatitis, and showed improvement in studied quality of life measures. Additionally, the reduction of itch intensity is important because itching is one of the most burdensome symptoms for patients and can impact other aspects of their lives, such as sleep."