| 2016-10-02 15:09:04|
REGN, SNY 15:09 10/02 10/02/16
Regeneron, Sanofi report data on Phase 3 studies of dermatitis drug Dupixent
Regeneron (REGN) and Sanofi (SNY) announced that detailed results from LIBERTY AD SOLO 1 and SOLO 2, two placebo-controlled Phase 3 studies evaluating investigational Dupixent, or dupilumab, in adult patients with inadequately controlled moderate-to-severe atopic dermatitis, were published in the New England Journal of Medicine. The 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. Specifically, at 16 weeks for SOLO 1 and SOLO 2, respectively, 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 5-point Investigator's Global Assessment scale, compared to 10 and 8 percent with placebo. This was the primary endpoint of the study in the U.S. and one of the primary endpoints in the EU. At 16 weeks for SOLO 1 and SOLO 2, respectively, 52 and 48 percent of adult patients who received Dupixent 300 mg weekly, and 51 and 44 percent of patients who received Dupixent 300 mg every two weeks, achieved a 75 percent or greater reduction in their Eczema Area and Severity Index score compared to 15 and 12 percent with placebo. This was the key secondary endpoint in the U.S. and one of the primary endpoints in the EU. At 16 weeks for SOLO 1 and SOLO 2, respectively, the percent improvement in EASI from baseline was 72 and 69 percent in patients who received the 300 mg weekly dose, and 72 and 67 percent for patients who received Dupixent 300 mg every two weeks, compared to 38 and 31 percent for placebo. The reduction in the daily intensity of patient-reported itch, as measured by the Pruritus Numerical Rating Scale, was a secondary endpoint that was met at 2 weeks, 4 weeks and 16 weeks. At 16 weeks, for SOLO 1 and SOLO 2, respectively, 40 and 39 percent of patients who received Dupixent 300 mg weekly and 41 and 36 percent of patients who received Dupixent 300 mg every two weeks achieved a four-point or greater reduction in their NRS score compared to 12 and 10 percent with placebo. 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 groups. The rate of serious adverse events was 1-3 percent for Dupixent and 5-6 percent for 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 -- and conjunctivitis. No patients discontinued therapy due to injection site reactions and one patient discontinued therapy due to conjunctivitis.