XBiotech’s Results from Phase 2 Atopic Dermatitis Study Suggest New Drug to Treat Skin Disease

XBiotech (NASDAQ:XBIT) announced today that its open label, proof of concept, multicenter study using bermekimab to treat patients with moderate to severe atopic dermatitis (AD) has completed and the study met all primary and secondary endpoints.

As quoted in the press release:

While clinically and statistically significant improvement was seen for all clinical endpoints in the high dose group, also notable was the speed, magnitude, and trajectory of responses seen. In the high dose group, for example, after only four weeks of treatment, 61% of patients achieved a 4-point improvement in the Pruritus Numerical Rating Scale (NRS), a key method used to measure itch in clinical trials for atopic dermatitis, and 75% of patients achieved a 4-point improvement by week 7. For the only biological therapy currently approved to treat atopic dermatitis, dupilumab, which was granted breakthrough designation by the FDA, only 16%-23% of patients achieved a 4-point NRS improvement after 4 weeks of therapy; and only 36-41% of patients achieved a 4-point improvement by week 16.

Atopic dermatitis, commonly referred to as eczema, is characterized by chronic inflammation of the skin, which results in a breakdown of the skin barrier and leads to dry, thickened, scaly skin, redness, and itching, the latter which can be debilitating and result in significant sleep disturbances and loss of quality of life. A survey of persons suffering from atopic dermatitis found that 91% of patients endured itching every day², and another study reported that 36% of patients feel that their primary treatment objective is to reduce itch. Further, international panels of dermatology experts have recommended itch as a crucial determinate of treatment effectiveness in the development of new therapies.

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