XBiotech Announces Rapid Enrollment for its Randomized Multi-Center Clinical Study for Bermekimab in Patients with Hidradenit...
November 19 2019 - 8:55AM
XBiotech Inc. (NASDAQ: XBIT) today announces rapid enrollment in
its randomized, double-blind, placebo-controlled Phase 2 clinical
study evaluating bermekimab in patients with moderate to severe
Hidradenitis Suppurativa (HS). The study is chaired by renowned
investigative dermatologist Alice Gottlieb, MD, PhD (Medical
Director of Dermatology at the Mount Sinai Beth Israel Campus and
Clinical Professor at the Icahn School of
Medicine at Mount Sinai) and will enroll approximately
150 patients. XBiotech announced the first patient enrolled in the
study on October 23, 2019. Today, XBiotech is already updating
status of the study, reporting that 51 patients have now been
randomized, or assigned to an investigational arm of the study.
Dr. Gottlieb commented, “The very strong
participation by clinical sites and by patients is indicative of
the substantial need for new therapy and of the favorable view of
bermekimab.”
Ms. Ashley Otero, XBiotech’s Director of
Clinical Operations, stated, “We are extremely excited about the
robust enrollment seen to date. After only a few weeks since
enrollment of the first patient, we have already randomized over
one-third of the intended study population. If this pace continues,
we will complete enrollment well ahead of our anticipated
timing.”
Bermekimab has been tested in two previous
clinical studies. In a recent open label study (n=42), 61% of
patients with no prior biological therapy and 63% of patients who
had failed previous biological therapy (i.e. adalimumab) achieved a
positive HiSCR at 12 weeks. Additionally, the majority of patients
in both groups achieved clinically significant reduction in pain
from their disease. These results were presented at the American
Academy of Dermatology (AAD) in 2019.
In an earlier double-blind, placebo controlled,
randomized study which also evaluated bermekimab in the treatment
of HS, the study’s primary endpoint was met, demonstrating
significant improvement of HiSCR in patients treated with
bermekimab compared to control after 12 weeks of therapy (response
rate of 60% vs 10%, respectively (p=0.035)). These results have
been published in a leading peer reviewed medical journal, the
Journal of Investigative Dermatology1.
The primary endpoint for the current study is
the percentage of subjects achieving a Hidradenitis Suppurativa
Clinical Response (HiSCR) at week 12. Multiple secondary efficacy
endpoints will be assessed after 12 and 16 weeks of therapy,
including: Numerical Rating Scale (NRS) for pain and itch; Modified
Sartorius Score; Dermatology Life Quality Index (DLQI); Hospital
Anxiety and Depression Scale (HADS); and Patient Global Impression
of Change and Severity (PGI-c, PGI-s). Please visit
www.clinicaltrials.gov for a more complete description of the
study.
About Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS) is a chronic,
inflammatory skin disorder affecting areas rich in apocrine glands.
Nodules appear in the affected areas and progressively become
swollen with spontaneous rupture and release of pus. This process
occurs repeatedly leading to formation of deep sinus tracts and
painful dermal abscesses1,[2]. Therefore, HS is often devastating
for patients with significant impact on quality of life [3].
The Dermatology Quality Life Index (DQLI) for HS is 8.9, being
higher than any other skin disorder4. Traditional treatments
comprise of antibiotics, antiandrogens and surgery. The global
prevalence for HS is estimated at up to 4% of the
population 5.
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.
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.
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 Kanni T et al. MABp1 Targeting Interleukin-1Alpha for Moderate
to Severe Hidradenitis Suppurativa not Eligible for Adalimumab: A
Randomized Study. J Invest Dermatol. 2017 Nov 9.2 Revuz
J. Hidradenitis suppurativa. J Eur Acad Dermatol
Venereol 2009; 23: 985-998.3 Alikhan A, Lynch PJ, Eisen DB.
Hidradenitis suppurativa: a comprehensive review. J Am Acad
Dermatol. 2009 Apr;60(4):539-61; quiz 562-3. doi:
10.1016/j.jaad.2008.11.911.4 Vasquez BG, Alikhan A, Weaver,
AL, et al. Incidence of hidradenitis suppurativa and associated
factors: a population-based study of Olmsted County,
Minnesota. J Invest Dermatol. 2013 Jan;133(1):97-103.
doi: 10.1038/jid.2012.255. Epub 2012 Aug 30.5 Révuz JE,
Canoui-Poitrine F, Wolkenstein P, et al. Prevalence and factors
associated with hidradenitis suppurativa: results from two
case-control studies. J Am Acad Dermatol 2008; 59:
695-701.
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