Regeneron Pharmaceuticals Inc. in Greenburgh has announced the results from a phase 2b dose-ranging study of dupilumab in adult patients with moderate-to-severe atopic dermatitis, a chronic form of eczema. The companies also announced that four earlier clinical studies of dupilumab were published Thursday in the New England Journal of Medicine.
Dupilumab is an investigational monoclonal antibody that blocks signaling of IL-4 and IL-13, two proteins that play a key role in the origin and development of moderate-to-severe atopic dermatitis.
“These clinical data, coupled with our phase 2a results in asthma last year, support the growing scientific evidence that the IL-4/IL-13 pathway may be a fundamental driver in allergic diseases,” said George D. Yancopoulos, chief scientific officer of Regeneron and president of Regeneron Laboratories. “Blocking IL-4/IL-13 signaling may provide an important new approach to atopic conditions, including asthma, atopic dermatitis and nasal polyposis, where we have ongoing clinical programs.”
The New England Journal of Medicine publication includes data from four placebo-controlled studies. Treatment with dupilumab, either as a monotherapy or in combination, was associated with improvement in skin damage and substantial improvements in itching.
Dupilumab is being co-developed with Sanofi, a Paris-based pharmaceutical manufacturer. The drug is under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority.