Sanofi and Regeneron combo shows superiority in late-stage atopic dermatitis trials

pharmafile | June 6, 2016 | News story | Research and Development, Sales and Marketing Dupilumab, Regeneron, Sanofi, atopic dermatitis, late stage trials 

Sanofi (NYSE: SNY) and Regeneron (NASDAQ: REGN) have announced positive results from a Phase III trial evaluating dupilumab in patients with moderate-to-severe atopic dermatitis.

Atopic dermatitis is a serious from of eczema which is characterised by itchy, inflamed skin that can be present on any part of the body. There are approximately 1.6 million people in the US alone who suffer from moderate-to-severe forms of the inflammatory disease.

In the LIBERTY AD CHRONOS trial, dupilumab met its primary and key secondary endpoints with topical corticosteroids (TCS) compared to TCS alone. Patients on the trial were inadequately controlled by topical corticosteroids with or without topical calcineurin inhibitor.

In the trial, dupilumab with TCS significantly improved measures of overall disease severity at 15 to 52 weeks when compared to placebo with TCS. At 52 weeks, 40% of patients receiving dupilumab achieved clearing or near-clearing of skin lesions, compared to 12.5% of patients receiving placebo. Similar results were observed at 52 weeks.

George D. Yancopoulos, chief scientific officer at Regeneron, says: “These are the first long-term Phase III data that demonstrated dupilumab with topical corticosteroids was superior to topical corticosteroids alone, and provided sustained efficacy, significantly improving measures of overall disease severity, skin clearing, itching and quality of life through one year of treatment.”

Elias Zerhouni, president of global R&D at Sanofi, comments: “These one-year data strengthen the earlier 16-week results, suggesting that dupilumab impacts the aberrant activation of the IL-4/IL-13 pathway which resulted in significant efficacy without the side effects associated with immune-suppressing therapies. We will continue to advance dupilumab for patients worldwide suffering from inadequately controlled moderate-to-severe atopic dermatitis, with the first regulatory submission planned in the US for the third quarter of this year.”

Sean Murray

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