Sanofi and Regeneron’s dupilumab has shown positive results in a Phase IIb study for moderate-to-severe atopic dermatitis, a serious, chronic form of eczema.
The data showed that all five subcutaneous doses of dupilumab showed an improvement in the primary endpoint, the mean percent change in the Eczema Area and Severity Index (EASI) score score from baseline to week 16. These ranged from a high of 74% for patients on 300mg weekly to a low of 45% for those on 100mg monthly; this compared to 18% for all doses for patients in the placebo group.
Meantime, data from two Phase IIa trials and two Phase I studies of dupilumab, which blocks the action of two proteins involved in inflammation, interleukin-4 and IL-13, were published in the New England Journal of Medicine. The data showed that the drug as monotherapy or in combination with topical glucocorticoids improved skin lesions and itching.
The data, “coupled with our Phase IIa results in asthma last year, support the growing scientific evidence that the IL4/IL-13 pathway may be a fundamental driver in allergic diseases,” said George Yancopoulos, Regeneron’s chief scientific officer. He added that blocking IL-4/IL-13 signalling “may provide an important new approach to atopic conditions, including asthma, atopic dermatitis and nasal polyposis”.
Elias Zerhouni, Sanofi’s R&D chief, 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”. He added that “we are now able to select the optimal doses for the phase 3 studies, which we anticipate to begin later this year”.
