Sanofi and Regeneron Pharmaceuticals, Inc. announce that detailed results from LIBERTY AD SOLO 1 and SOLO 2, two placebo-controlled Phase 3 studies evaluating investigational Dupixent® (dupilumab) in adult patients with inadequately controlled moderate-to-severe atopic dermatitis (AD), were published in The New England Journal of Medicine (NEJM). The studies met their primary endpoints evaluating 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. 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 in certain atopic or allergic diseases, includingasthma andnasal polyposis, where Dupixent is being evaluated in ongoing clinical trials.
“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 significant reduction in the signs and symptoms of atopic dermatitis, and showed improvement in studied quality of life measures,” said Eric Simpson, M.D., M.C.R., Oregon Health & Science University, and lead author of the NEJM paper. “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.”
Other positive secondary endpoints discussed in the NEJM paper include improvement in patient-reported anxiety and depression symptoms and certain quality of life measures as evaluated by Scoring Atopic Dermatitis (SCORAD), Hospital Anxiety and Depression Scale (HADS), Patient-Oriented Eczema Measure (POEM), and Dermatology Life Quality Index (DLQI).
For the 16-week treatment period, the overall rate of adverse events (65-73 percent Dupixent and 65-72 percent placebo) was comparable between the Dupixent groups and the placebo groups. The proportion of patients who completed the treatment period was 88-94 percent for Dupixent and 80.5-82 percent for placebo. The rate of serious adverse events was 1-3 percent for Dupixent and 5-6 percent for placebo. Serious or severe infections were similar in the Dupixent and placebo groups in both studies (1 percent Dupixent and 1 percent placebo). Adverse events that were noted to have a higher rate with Dupixent treatment across both studies included injection site reactions (8-19 percent Dupixent; 6 percent placebo), conjunctivitis (1-5 percent Dupixent; 1 percent placebo). No patient discontinued therapy due to injection site reactions and one patient discontinued therapy due to conjunctivitis.
The Dupixent Biologics License Application (BLA) was recently accepted for Priority Review by the U.S. Food and Drug Administration (FDA) with a target action date of March 29, 2017. The FDA granted Dupixent Breakthrough Therapy designation in uncontrolled moderate-to-severe atopic dermatitis in 2014. The European Medicines Agency (EMA) and FDA have conditionally accepted Dupixent as the trade name for dupilumab.
Dupixent is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority. In addition to AD, Dupixent is being evaluated in asthma, nasal polyposis and eosinophilic esophagitis. If approved, Dupixent would be commercialized by Regeneron and Sanofi Genzyme, the specialty care global business unit of Sanofi.