Sanofi and Regeneron Announce Presentation of Positive Data from Long-Term Pivotal Phase 3 CHRONOS Study of Dupixent® (dupilumab) in Moderate-to-Severe Atopic Dermatitis

Sanofi and Regeneron Announce Presentation of Positive Data from Long-Term Pivotal Phase 3 CHRONOS Study of Dupixent^® (dupilumab) in Moderate-to-Severe Atopic Dermatitis

            - Late-breaking oral abstract to be presented today at the Annual Meeting of the American Academy of Dermatology -

Paris, France and Tarrytown, N.Y. - March 4, 2017 - Sanofi and Regeneron Pharmaceuticals, Inc. today presented detailed results from the one-year Phase 3 CHRONOS study, which showed that patients receiving the investigational drug Dupixent^® (dupilumab) with topical corticosteroids (TCS) achieved significantly improved measures of overall disease severity compared to TCS alone in adults with uncontrolled moderate-to-severe atopic dermatitis (AD). The data will be presented today as a late-breaking oral abstract at the Annual Meeting of the American Academy of Dermatology (AAD) taking place in Orlando, Florida.

"These new results build upon previous positive Phase 3 monotherapy data. In the CHRONOS study, Dupixent used with topical corticosteroids showed significantly greater clearance of skin lesions and overall disease severity compared to  topical corticosteroids alone, which are commonly prescribed for moderate-to-severe atopic dermatitis," said Andrew Blauvelt, M.D., President of Oregon Medical Research Center and principal investigator of the study. "This study provides positive long-term data for Dupixent, which is important given atopic dermatitis is a chronic inflammatory disease. Additionally, the presentation highlights the critical role of IL-4 and IL-13 as drivers of this atopic condition."

Patients were eligible for participation in the CHRONOS study if their disease was uncontrolled by topical medicines including corticosteroids with or without calcineurin inhibitors. Patients were randomized to receive Dupixent 300 mg weekly with TCS, Dupixent 300 mg every two weeks with TCS, or placebo with TCS. Dupixent with TCS significantly improved measures of overall disease severity at 16 and 52 weeks when compared to placebo with TCS.

As previously announced in June 2016, the primary endpoint results at week 16 and secondary endpoint 52-week results were the following:

• At 16 weeks, 39 percent of patients who received either Dupixent 300 mg weekly with TCS or Dupixent 300 mg every two weeks with TCS achieved clear or almost clear skin (IGA 0 or 1), compared to 12 percent of patients receiving placebo with TCS (p less than 0.0001).
• At 16 weeks, 64 percent of patients who received Dupixent 300 mg weekly with TCS, and 69 percent of patients who received Dupixent 300 mg every two weeks with TCS achieved EASI-75, a 75 percent reduction on an index measuring eczema severity, compared to 23 percent of patients receiving placebo with TCS (p less than 0.0001).
• At 52 weeks, 40 percent of patients who received Dupixent 300 mg weekly with TCS, and 36 percent of patients who received Dupixent 300 mg every two weeks with TCS achieved clear or almost clear skin (IGA 0 or 1), compared to 12.5 percent of patients receiving placebo with TCS (p less than 0.0001).
• At 52 weeks, 64 percent of patients who received Dupixent 300 mg weekly with TCS, and 65 percent of patients who received Dupixent 300 mg every two weeks with TCS achieved EASI-75, compared to 22 percent with placebo with TCS (p less than 0.0001).

New data being presented at the meeting show that: