XBiotech (XBIT) Says Results from Phase 2 Clinical Trial of Bermekimab in Treatment of Atopic Dermatitis to be Presented at ADD

March 1, 2019 11:46 AM EST

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XBiotech (NASDAQ: XBIT) announced today that breakthrough results from its Phase 2 clinical trial of its antibody therapy, bermekimab, are being presented tomorrow at a late-breaking oral presentation during the annual meeting of the American Academy of Dermatology (AAD) being held in Washington, DC. The presentation titled, “Bermekimab is a Rapid and Effective Treatment for Atopic Dermatitis (AD)” will take place on Saturday, March 2 at 1:10pmET in Ballroom A and will be presented by international dermatology expert, and lead researcher in the development of approved therapies for atopic dermatitis, Eric Simpson, M.D, M.C.R. Professor of Dermatology at Oregon Health & Science University, School of Medicine.

The results being presented by Dr. Simpson demonstrate that bermekimab treatment resulted in rapid and significant improvement of disease in patients with moderate-to-severe AD. After only 7 weeks of treatment, 71% of patients that received a 400mg bermekimab weekly regimen had at least 75% reduction in their disease, as measured by the Eczema Area and Severity Index (EASI) score (this compares to 44-51% of patients achieving 75% improvement in EASI score after 16 weeks therapy as reported for two Phase III clinical trials for the existing FDA approved biological drug for AD). Moreover, within 7 weeks, using patient reported Numerical Rating Scale (NRS) for itch and pain, patients receiving the 400mg bermekimab treatment regimen had 71% reduction in itch and an 84% reduction in pain (this compares to 36-41% reduction in itch [pain was not reported] after 16 weeks of treatment with the existing approved therapy for AD).

XBiotech CEO John Simard commented, “We are thrilled to have Dr. Simpson present these findings at the AAD tomorrow. We expect these results to enable the advancement of a new and very important treatment for what is a rather under appreciated disease in terms of its severity and wide-spread impact on the lives of people around the world.”

In the study, 38 patients in two treatment groups received a low (200mg) or high (400mg) dose of bermekimab once weekly for either a 4 or 7-week treatment regimen, respectively. There was statistically and clinically significant improvement in treatment response for key measures of disease severity in the high dose versus the low dose group.



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