News Feature | July 11, 2014

Regeneron And Sanofi Post Positive Phase 2B Data For Dupilumab In AD

By Estel Grace Masangkay

Regeneron Pharmaceuticals and its partner Sanofi posted positive results from a dose-ranging Phase 2B trial of dupilumab for the treatment of atopic dermatitis (AD).

Dupilumab is a fully human monoclonal antibody that works to block IL-4 and IL-13 signaling, two cytokines implicated in the origin of moderate to severe AD. The drug was produced using Regeneron’s VelocImmune technology and is under joint development with Sanofi for AD, asthma, and nasal polyposis.

In the double blind, placebo-controlled, dose ranging, Phase 2B study, all doses of the drug achieved the primary endpoint, which was increased improvement in Eczema Area and Severity Index (EASI) scores from baseline compared to placebo. The EASI scores ranged from the highest 74 percent for patients in the high dose group (300 mg weekly) to a low of 45 percent in patients who received the lowest dose (100 mg monthly).

George D. Yancopoulos, CSO of Regeneron and President of Regeneron Laboratories, said, “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. 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."

Atopic dermatitis is a serious and chronic form of eczema. AD is a systemic inflammatory disease that is caused by an immune cells subset named Type 2 helper cells. IL-4 and IL-3 play an important role in the initiation and maintenance of the allergic response to this immune cells subset. Moderate to severe AD is characterized by skin lesions, intense itching, lichentification, redness, dryness, and skin damage that could lead to secondary infections.

Elias Zerhouni, President of Global R&D, at Sanofi said, “Atopic dermatitis is known to have a profoundly negative effect on quality of life, and people with more severe forms of this disease have limited therapeutic choices. 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.” Zerhouni said that the findings enable the companies to choose the optimal doses for upcoming Phase III studies this year. 

Four previous clinical studies of the drug in moderate to severe AD were also published in the New England Journal of Medicine (NEJM).