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Sanofi and Regeneron Report Positive Proof-of-Concept Data for Dupilumab, an IL-4R alpha Antibody, in Atopic Dermatitis
Date:3/2/2013

yngitis (19.6% vs 12.5% for placebo) and headache (11.8% vs 6.3% for placebo).

"Despite existing therapies, a significant proportion of patients with moderate-to-severe atopic dermatitis continue to suffer from inflamed skin and intractable itch, which significantly impacts their quality of life," said Dr. Eric Simpson , Associate Professor, Director of Clinical Studies, Oregon Health and Science University, Portland, Oregon, USA, and Principal Investigator of the study.  "The early phase results with this biologic therapy, which has a novel mechanism of action, are encouraging to those of us who treat these patients and warrant further clinical investigation."

"Through blockade of IL-4R alpha, dupilumab modulates signaling of both the IL-4 and IL-13 pathway, which have been implicated in the pathophysiology of allergic disease," said George D. Yancopoulos , M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories.  "We look forward to presenting additional data from a 12-week, Phase 2a trial in atopic dermatitis, as well as starting a larger Phase 2b trial with dupilumab in patients with atopic dermatitis, later this year."

Presented today in a late-breaking clinical trials session at the AAD meeting, the Phase 1b trials included 67 patients randomized to three different doses of dupilumab (75mg, n=8; 150mg, n=22; 300mg, n=21) and placebo (n=16).  The primary objective of the Phase 1b studies was to assess the safety profile of dupilumab.  Other endpoints included pharmacokinetic, biomarker, and efficacy parameters.  Following the 4-week treatment period, patients in the studies were followed for an additional 4 weeks for a total of 8 weeks.

About IL-4R and the IL-4/IL-13 Pathway
Atopic dermatitis and some types of asthma are characterized by the induction of a specific type of an immune res
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SOURCE Regeneron Pharmaceuticals, Inc.
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