XBiotech Inc.'s experimental skin disease drug bermekimab was found to be safe and tolerable in patients with atopic dermatitis during a mid-stage study and showed promise compared to Sanofi and Regeneron Pharmaceuticals Inc.'s U.S.-approved treatment Dupixent.
Atopic dermatitis, or eczema, is a chronic condition that makes skin thick, dry, red and itchy. There is no current cure for atopic dermatitis, only treatments and self-measures to relieve itching and prevent new outbreaks.
The open-label phase 2 trial enrolled a total of 38 patients, of which 10 received a 200-milligram dose of bermekimab for four weeks and 28 received a 400-milligram dose for seven weeks. Each group received weekly injections that contain a concentrated formula of bermekimab, also known as MABp1. According to Austin, Texas-based XBiotech, the study met all primary and secondary endpoints.
The group receiving the higher dose displayed statistically significant improvement in all efficacy endpoints. After four weeks of treatment, 61% of patients in the high-dose group achieved a four-point improvement in the Pruritus Numerical Rating Scale, or NRS, a key gauge of itchiness in clinical trials. By week seven, 75% of patients in that group had improved their NRS scores by four points.
The drug performed better in the high-dose group than Dupixent, the only biologic medicine approved by the U.S. Food and Drug Administration to treat atopic dermatitis, did in two previous studies in terms of NRS improvement. Two phase 3 trials of Dupixent, SOLO 1 and SOLO 2, recorded four-point NRS improvements for 16% to 23% of patients after four weeks of treatment and for 36% to 41% of patients after 16 weeks, XBiotech noted.
During the bermekimab study, 39% and 71% of high-dose patients achieved a 75% improvement in the Eczema Area and Severity Index score after four weeks and seven weeks, respectively. In comparison, the research on Dupixent, which is also known as dupilumab, found that only 44% to 51% of patients achieved a 75% improvement in the index score after 16 weeks.
According to XBiotech, atopic dermatitis affects 18 million people in the U.S., and the economic impact of the disease is estimated to be about $40 billion.
XBiotech develops antibodies for treating diseases such as cancer, inflammatory conditions and vascular diseases.