XBiotech Announces First Patient Enrolled in Placebo-Controlled Clinical Study Evaluating Its anti-IL-1⍺ Therapy Bermekimab...
November 12 2019 - 08:45AM
XBiotech Inc. (NASDAQ: XBIT) has enrolled the first patient in a
randomized, double-blind, placebo-controlled Phase 2 clinical study
to evaluate its IL-1a blocking antibody therapy in patients with
moderate to severe Atopic Dermatitis (AD) (also known as Eczema).
Chaired by award-winning dermatologist Seth B. Forman, MD, of
ForCare Medical Group in Tampa, FL, the study will assess weekly
bermekimab therapy to reduce inflammatory skin lesions, itch, and
pain in patients suffering from eczema.
The study will compare three groups of patients
over 16 weeks of treatment: a weekly dosing group, a biweekly
dosing group, and a placebo group. Percentage of patients who
achieve a 75% reduction in skin disease after 16 weeks of treatment
will be the primary measure of response. The Eczema Area
Severity Index (EASI) scoring system will be used to assess
severity of inflammatory skin lesions. Another crucial assessment
will be patient itch, which is often severe and unrelenting in this
disease. A numeric rating scale (NRS) will be used to assess itch
and pain at various timepoints ranging from 4-16 weeks. For more
information on this study please visit www.clinicaltrials.gov.
Dr. Forman commented, “We are now understanding
that IL-1alpha (IL-1⍺) plays a primary role in inflammatory skin
diseases. Earlier Phase 2 results using the IL-1⍺ blocker,
bermekimab, showed unprecedented treatment effects such as
reduction of inflammatory lesions, itch, and pain in patients with
eczema. I look forward to the outcome of this study.”
Bermekimab was previously tested in a clinical
study of patients with moderate to severe AD. Those results were
previously presented at the annual conferences of the American
Academy of Dermatology (AAD) and the European Academy of
Dermatology and Venerology (EADV) by renowned dermatologists Dr.
Eric Simpson and Dr. Alice Gottlieb, respectively. The findings
showed that after only 8 weeks of bermekimab therapy, 75% of
patients had achieved 75% improvement in disease severity as
assessed by EASI score (the current standard of care for biological
therapy involves a 16 week treatment regimen and is associated with
44-51% of patients achieving 75% improvement). Bermekimab therapy
was also associated with a dramatic reduction in itch and pain,
with three fourths of patients achieving clinically significant
reduction in itch, and 86% achieving clinically significant
reduction in pain after only 8 weeks of treatment.
John Simard, the Company’s President and CEO,
stated, “I am grateful to Dr. Forman for leading this important
study. Results from our earlier study suggest that bermekimab has
the potential to change the paradigm for treating moderate to
severe AD and to improve quality of life for millions of patients
suffering from this disease.”
Inflammation plays a major role in the induction
and progression of several skin diseases, including eczema or
atopic dermatitis1. Bermekimab blocks the action of the potent
inflammatory substance IL-1⍺ found in skin. It has been
demonstrated that IL-1⍺ is necessary for inducing chronic skin
inflammation through aberrant stores of intracellular IL-1⍺ in
keratinocytes, which constitute approximately 90% of skin cells.
IL-1⍺ secretion has shown not only to be necessary component in
driving skin inflammation, but by itself sufficient to do so2.
Therefore, neutralizing IL-1⍺ activity through an inhibitor such as
bermekimab has promise to resolve chronic skin inflammation and
looks to be a key target for treating atopic dermatitis, along with
other inflammatory skin diseases.
About Atopic DermatitisAtopic
dermatitis (AD) is an inflammatory skin disease affecting as much
as 20% of the population in western industrial societies. Chronic
eczema in AD and associated pruritus can be a significant cause of
morbidity and impact life quality. Disease pathogenesis is complex
but ultimately converges on a pathological inflammatory process
that disrupts the protective barrier function of the skin.
Keratinocytes are a major reservoir of IL-1⍺ and may be a key
source of inflammatory stimulus in AD. IL-1⍺ is present on
leukocytes, where its role in leukocyte trafficking and
infiltration may represent a key step in the chronic inflammation
of AD. IL-1⍺ is a key inducer of matrix metalloproteinases activity
which could be directly involved in the epithelial barrier
breakdown in AD3. Loss of regulation of IL-1 results in systemic
inflammation with extensive skin involvement4.
About XBiotech XBiotech is
a fully integrated, global biopharmaceutical company dedicated to
pioneering the discovery, development and commercialization of
therapeutic antibodies. XBiotech currently is advancing a pipeline
of therapies based on harnessing naturally occurring antibodies
from patients with immunity to certain diseases. The approach to
use natural human immunity as a source of new medicines offers the
potential to redefine the standards of care a wide range of
diseases. Headquartered in Austin, Texas, XBiotech also is leading
the development of innovative manufacturing technology to reduce
the cost and complexity of biological drug production. For more
information, visit www.xbiotech.com.
Cautionary Note on Forward-Looking
StatementsThis press release contains forward-looking
statements, including declarations regarding management's beliefs
and expectations that involve substantial risks and uncertainties.
In some cases, you can identify forward-looking statements by
terminology such as "may," "will," "should," "would," "could,"
"expects," "plans," "contemplate," "anticipates," "believes,"
"estimates," "predicts," "projects," "intend" or "continue" or the
negative of such terms or other comparable terminology, although
not all forward-looking statements contain these identifying words.
Forward-looking statements are subject to inherent risks and
uncertainties in predicting future results and conditions that
could cause the actual results to differ materially from those
projected in these forward-looking statements. These risks and
uncertainties are subject to the disclosures set forth in the "Risk
Factors" section of certain of our SEC filings. Forward-looking
statements are not guarantees of future performance, and our actual
results of operations, financial condition and liquidity, and the
development of the industry in which we operate, may differ
materially from the forward-looking statements contained in this
press release. Any forward-looking statements that we make in this
press release speak only as of the date of this press release. We
assume no obligation to update our forward-looking statements
whether as a result of new information, future events or otherwise,
after the date of this press release.
ContactAshley
Oteroaotero@xbiotech.com512-386-2930
_______________________________
1 Bou-Dargham MJ Et al. The Role of Interleukin-1 in
Inflammatory and Malignant Human Skin Diseases and the Rationale
for Targeting Interleukin-1 Alpha. Med Res Rev. 2017
Jan;37(1):180-216. doi: 10.1002/med.21406. Epub 2016 Sep 8.2 Archer
NK et al. Injury, dysbiosis, and filaggrin deficiency drive skin
inflammation through keratinocyte IL-1a release. J Allergy Clin
Immunol. 2019 Apr;143(4):1426-1443.e6. doi:
10.1016/j.jaci.2018.08.042. Epub 2018 Sep 19.3 Han et al.
Interleukin-1alpha-induced proteolytic activation of
metalloproteinase-9 by human skin. Surgery. 2005 Nov;138(5):932-9.4
Askentijevich et al. An autoinflammatory disease with deficiency of
the interleukin-1-receptor antagonist. N Engl J Med. 2009 Jun
4;360(23):2426-37.
XBiotech (NASDAQ:XBIT)
Historical Stock Chart
From Feb 2024 to Mar 2024
XBiotech (NASDAQ:XBIT)
Historical Stock Chart
From Mar 2023 to Mar 2024