Regeneron, Sanofi Announce Positive Results From Ph 2b Study Of Dupilumab

(RTTNews) - Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi (SNY) on Wednesday announced positive results from a Phase 2b dose-ranging study of dupilumab, an investigational therapy, in adult patients with moderate-to-severe atopic dermatitis, a serious, chronic form of eczema.

All doses of dupilumab met the primary endpoint of a greater improvement in Eczema Area and Severity Index scores from baseline compared to placebo.

In addition, the companies also said that four earlier clinical studies of dupilumab in moderate-to-severe atopic dermatitis were published today in the New England Journal of Medicine.

Dupilumab is an investigational monoclonal antibody that blocks signaling of IL-4 and IL-13, two cytokines that play a key role in the pathogenesis of moderate-to-severe atopic dermatitis.

In the Phase 2b trial, all five subcutaneous doses of dupilumab showed a dose-dependent improvement in the primary endpoint, the mean percent change in EASI score from baseline to week 16. The improvements in EASI score ranged from a high of 74% for patients in the highest dose group, who received 300 milligrams (mg) weekly, to a low of 45% in patients who received the lowest dose of 100 mg monthly, compared to 18% for patients in the placebo group.

Elias Zerhouni, President, Global R&D, Sanofi, said, "These latest results are consistent with what was observed in the earlier clinical studies and add to the body of evidence that investigational dupilumab may have a role to play for patients with moderate-to-severe atopic dermatitis. We are now able to select the optimal doses for the phase 3 studies, which we anticipate to begin later this year."