Regeneron, Sanofi Tout Phase III Dupixent Data

October 3, 2016
By Alex Keown, BioSpace.com Breaking News Staff

TARRYTOWN, N.Y. – An atopic dermatitis treatment in Phase III development by Regeneron Pharmaceuticals and Paris-based Sanofi met primary endpoints in two placebo-controlled trials, the companies jointly announced Oct. 1 the European Academy of Dermatology and Venereology Congress.

Data from the two trials of 1,379 patients showed that Dupixent (dupilumab) indicated the drug was successful in clearing the rash associated with atopic dermatitis. The drug also successfully met its secondary endpoint in reducing the itch-factor associated with the skin disease. 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 atopic dermatitis. The drug is also being evaluated as a potential treatment for other allergic diseases including asthma, eosinophilic esophagitis and nasal polyposis. Results of the two trials have been published in the “New England Journal of Medicine.”

Eric Simpson, the lead author of the NEJM paper said the clinical trials evaluating Dupixent in atopic dermatitis 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,” Simpson said in a statement.

According to the two trials. 37 and 36 percent of adult patients who received Dupixent 300 mg weekly, and 38 and 36 percent of patients who received Dupixent 300 mg every two weeks, achieved clearing or near-clearing of skin lesions as measured by the five-point Investigator's Global Assessment (IGA) scale, compared to 10 and 8 percent with placebo.Data showed about half of the patients who received a weekly 300 mg dose of Dupixent achieved a 75 percent or greater reduction in their Eczema Area and Severity Index score (EASI-75) compared to 15 and 12 percent with placebo.

Moderate-to-severe atopic dermatitis, a serious, chronic form of eczema, is characterized by rashes and can include intense itching, skin dryness, cracking, redness, crusting, and oozing. Even though atopic dermatitis symptoms appear on the skin, they are fueled by a continuous cycle of underlying inflammation triggered in part by a malfunction in the immune system.

The U.S. Food and Drug Administration is expected to rule on Dupixent by March 29, 2017. The drug was granted a Breakthrough Therapy Designation in 2014. On Sept. 26 the FDA granted priority review to Dupixent.

Sanofi and Regeneron have had a strong working relationship. In addition to the atopic dermatitis drug, the companies combined forces to develop Sarilumab as a treatment for rheumatoid arthritis. Last year, the U.S. Food and Drug Administration approved Praluent, the PSCK9 inhibitor targeting high cholesterol developed by both companies.

If approved, Dupixent would be commercialized by Regeneron and Sanofi Genzyme , the specialty care global business unit of Sanofi.

Shares of Regeneron are up this morning, trading at $405.50. Shares of Sanofi are also on the rise, trading at $38.35.