Dr. Seth Forman to Chair XBiotech’s Second Phase 2 Study of Bermekimab in Atopic Dermatitis
July 11 2019 - 8:30AM
Dr. Seth Forman to Chair XBiotech’s Second Phase 2 Study of
Bermekimab in Atopic Dermatitis
XBiotech (NASDAQ: 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.
About True Human™ Therapeutic
AntibodiesXBiotech’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.
About XBiotech 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, visit
www.xbiotech.com.
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ContactAshley
Oteroaotero@xbiotech.com512-386-2930
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