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Sanofi and Regeneron announce positive Phase III trial results for chronic skin disease treatment

Published on 01/04/16 at 08:50am

Sanofi (NYSE: SNY) and Regeneron Pharmaceuticals (NASDAQ: REGN) have announced positive top line results for dupilumab in Phase III clinical trials for chronic inflammatory skin disease, atopic dermatitis.

This severe form of eczema affects 1-3% of adults worldwide, and an estimated 7-8 million adults in the US alone.

In the LIBERTY AD SOLO 1 and SOLO 2 clinical trials, treatment with dupilumab as monotherapy showed significantly improved measures of overall disease severity, skin clearing, itching, quality of life and mental health.

1,379 adult patients with moderate-to-severe atopic dermatitis took part in the trials, as many as 72% of patients observed an improvement in their Eczema Area and Severity Index (EASI), while almost 40% achieved clearing or near-clearing of skin lesions, which was a primary endpoint of the study in the US.

George D Yancopoulos, chief scientific officer at Regeneron, comments: “These data provide strong evidence that the IL-4 and IL-13 signalling pathway is a fundamental driver of inflammation in atopic dermatitis. Dupilumab is the first in a new class of immunotherapies – in these 16 week trials, dupilumab blocked the aberrant activation of this pathway, resulting in significant efficacy without evidence of immune-suppressing side effects.”

Elias Zerhouni, president of global R&D at Sanofi, says: “There are no approved systemic therapies in the US for people with moderate-to-severe atopic dermatitis, underscoring the clear unmet need. These results may bring new hope to AD patients, many of whom have suffered for years.

“In the US, where dupilumab in atopic dermatitis has been granted Breakthrough Therapy designation by the US FDA, we plan to submit a regulatory application in the third quarter of the year and will work to bring this innovative therapy to patients as quickly as possible.”

Sean Murray

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