TAMPA, Fla. – XBiotech (NASDAQ: XBIT) has announced that Dr. Seth Forman, M.D., founder of Tampa’s ForCare Clinical Research and ForCare Medical Group, 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.
XBiotech’s President and 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 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.
“We are just now beginning to appreciate the key role that IL-1 alpha (IL-1?) plays in inflammatory skin disease,” Dr. Forman said. “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.”
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 seven million Ameicans 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.
About True Human™ Therapeutic Antibodies
XBiotech’s True Human™ antibodies are the only available antibodies derived without modification from humans who possess natural immunity to certain diseases. (Unlike all commercially available antibodies, which are called “Humanized” or “Fully Human”, XBiotech’s True Human™ antibodies are directly sourced from the natural human immune response for specific diseases without modification, and thereby have not been shown to cause immunogenicity.) With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.
XBiotech is a fully integrated global biosciences company dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies based on its True Human™ proprietary technology. XBiotech currently is advancing a robust pipeline of antibody therapies to redefine the standards of care in oncology, inflammatory conditions and infectious diseases. Headquartered in Austin, Texas, XBiotech also is leading the development of innovative biotech manufacturing technologies designed to more rapidly, cost-effectively and flexibly produce new therapies urgently needed by patients worldwide. For more information, visitwww.xbiotech.com.
About ForCare Clinical Research
ForCare Clinical Research is the clinical research arm of ForCare Medical Group based in Tampa, Fla. ForCare Medical Group specializes in Primary Care, Rheumatology and Dermatology. With one center on Ehrlich Rd. and a brand new state-of-the-art, 30,000-square foot facility opening soon on Florida Ave., ForCare has served those in the Tampa area for 10 years. ForCare’s physicians and staff are dedicated to providing excellent care, utilizing the most advanced technology and procedures. More information about ForCare Medical Group is available by calling 813.940.2600 and is online at www.ForCareMed.com.