XBiotech bermekimab study meets primary, secondary endpoints

XBiotech announced that its open label, proof of concept, multicenter study using bermekimab to treat patients with moderate to severe atopic dermatitis, or AD, has completed and the study met all primary and secondary endpoints. Thirty eight patients in two treatment groups received a low or high dose of bermekimab once weekly for either a four or seven-week treatment regimen, respectively. Statistically significant improvement was seen for all efficacy endpoints in the high dose group; and a significant dose response for the high dose compared to low dose group was observed for key endpoints, including the Eczema Area and Severity Index, or EASI, Global Individual Sign Score, or GISS, Patient Oriented Eczema Measure, or POEM, Hospital Anxiety and Depression Scale, or HADS, and SCORing Atopic Dermatitis, or SCORAD. 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, or 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. Another key measure of efficacy in the XBiotech study was the EASI. In the study, 39% of high dose patients achieved 75% improvement in EASI score after four weeks of therapy and 71% of patients achieved EASI-75 at week seven. Of note, participants were not allowed to use concomitant topical corticosteroids during the study and thus these improvements were most likely due to the study drug alone. The only approved biological therapy, dupilumab, reports only 44-51% of patients achieved EASI-75 by week 165.

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