Upcoming randomized, double-blind, placebo controlled Phase 2 study follows recent successful open label study in Atopic Dermatitis (AD)
AUSTIN, Texas, July 11, 2019 (GLOBE NEWSWIRE) -- XBiotech (XBIT) announces that Seth Forman, M.D., will Chair the Company’s upcoming randomized, double-blind, placebo controlled Phase 2 study in Atopic Dermatitis (AD). This second Phase 2 study of bermekimab to treat moderate to severe AD in adults will build on results of a recently completed randomized study that showed rapid improvement in inflammatory lesions and pruritus.
Dr. Forman is Board Certified in Dermatology and Dermatopathology, and has written numerous peer-reviewed articles in dermatology, including inflammatory skin conditions such as atopic dermatitis. He is the principal author of two chapters in the leading reference textbook for dermatologic therapeutics, Comprehensive Dermatologic Drug Therapy.
Dr. Forman commented, “We are just now beginning to appreciate the key role that IL-1 alpha (IL-1⍺) plays in inflammatory skin disease. XBiotech’s recent Phase 2 results using its IL-1⍺ blocker, bermekimab, to treat AD were exceptional, including rapid and dramatic reduction of inflammatory lesions and pruritus. Bermekimab represents a potential breakthrough for the treatment of atopic dermatitis and I look forward to confirming these results in the upcoming larger, randomized study.”
XBiotech’s President & CEO, John Simard, stated, “We are honored to have Dr. Forman chair this study and to have his support in advancing the bermekimab program in atopic dermatitis.”
Dr. Forman was a principal investigator in XBiotech’s recent open label study which demonstrated that weekly treatment with bermekimab resulted in rapid and significant improvement of disease in patients with moderate to severe AD. The following outcomes were demonstrated in the study:
After only eight weeks of treatment (versus the standard 16 weeks of treatment with the only currently available biologic for AD), patients achieved the following clinically significant results:
- 75% of patients, EASI 75 (≥75% improvement from baseline in the Eczema Area and Severity Index)
- 80% of patients, reduction in overall pain ≥4 points (Numerical Rating Scale for Pain)
- 75% of patients, a reduction in overall itch ≥4 points (Numerical Rating Scale for Itch)
- 79% of patients, a reduction in anxiety score ≥4 points (HADS Anxiety Score)
- 75% of patients, a reduction in depression score ≥4 points (HADS Depression Score)
In addition, after only four weeks of treatment, patients treated with bermekimab had already achieved the following:
- 66% reduction in skin lesions (p>0.001), as measured by the Eczema Area and Severity Index
- 57% reduction in worst itch (p>0.001), as measured by the Numerical Rating Scale for Itch
- 61% reduction in worst pain (p>0.001), as measured by the Numerical Rating Scale for Pain
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. There’s an estimated 18 million people with AD in the United States and the incidence is believed to be increasing in industrialized countries. Nearly 7 million persons in the U.S. are believed to have atopic dermatitis that is considered moderate to severe, which is the disease severity of subjects treated in the present study. The economic impact of AD is significant, with an estimate of nearly $40 billion in costs annually.
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