XBiotech Announces First Patient Enrolled in Randomized Multi-Center Clinical Study Evaluating Bermekimab Therapy in Patients...
October 23 2019 - 8:15AM
XBiotech Inc. (NASDAQ: XBIT) announced today that the first patient
was enrolled in its randomized, double-blind, placebo-controlled
Phase 2 clinical study evaluating bermekimab in patients with
moderate to severe Hidradenitis Suppurativa (HS). The multi-center,
international study will enroll approximately 150 patients into
three arms: two bermekimab dosing regimens versus a placebo arm
over sixteen (16) weeks of therapy. 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.
The study’s primary endpoint is the percentage
of subjects achieving 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.
Dr. Gottlieb commented, “With bermekimab we now
have a potential new tool in the toolbox to treat diseases like
hidradenitis suppurativa. Targeting IL-1⍺ represents a new class of
medication. I am pleased that we are underway with a large
randomized study that we can expect will provide definitive
findings for this novel therapy.”
John Simard, XBiotech CEO, stated, “HS is a
cornerstone for our bermekimab dermatology franchise. We are
excited to launch this large randomized study. We expect this
study will corroborate the promising safety and efficacy results
seen in our previous clinical trials of bermekimab to treat HS,
including rapid and dramatic reduction of pain. Our True Human
antibody platform harnesses the human body’s natural antibody
response to disease, and we hope that in the case of HS, bermekimab
will offer an effective, safe relief to people with this difficult
condition.”
Bermekimab has demonstrated its safety and
efficacy treating HS in two previous clinical studies. A recent
open label study demonstrated that weekly bermekimab is an
effective therapy, as measured by improvement in disease according
to HiSCR, the key measure of disease in HS. In the study, 61%
of patients with no prior biological therapy achieved positive
HiSCR at 12 weeks1, and 63% of patients who had failed previous
biological therapy (i.e. adalimumab) achieved a positive HiSCR at
12 weeks. Another unrivaled finding in the study was a significant
treatment-related reduction of pain in HS patients. Reducing pain
is widely recognized among experts as a key objective for HS
treatment, but this symptom has been largely unaddressed by
available drugs. Pain was assessed with a patient questionnaire
using a numerical rating scale from 0 to 10. A 30% and ≥1-unit
reduction in pain score is considered a clinically important relief
from pain, and no approved monotherapy for HS has elicited a
clinically significant effect on pain2.
Remarkably, a substantial majority of patients
treated with weekly bermekimab achieved this endpoint:
67% and 72% at week 12 who had
prior or no prior anti-TNF therapy, respectively.
An earlier double-blind, placebo controlled,
randomized study also evaluated bermekimab in the treatment of HS.
The study met its primary endpoint, 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))3. These results have been published in the
Journal of Investigative Dermatology
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 abscesses4,5. Therefore, HS is often devastating for
patients with significant impact on quality of life6. The
Dermatology Life Quality Index (DLQI) for HS is 8.9, being
higher than any other skin disorder7. Traditional treatments
comprise of antibiotics, antiandrogens and surgery. The global
prevalence for HS is estimated at up to 4% of the population5.
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 HiSCR response rates at
week 12 were 42% and 59% in the so called PIONEER I and PIONEER II
Phase III studies with the FDA-approved drug adalimumab,
respectively. Only 28% and 46% of patients achieved clinically
relevant pain reduction (as defined above) in the PIONEER I and
PIONEER II studies, respectively. In the PIONEER II study,
patients received adalimumab as a combination therapy with
antibiotics. Pain reduction results were not significant (compared
to placebo) in PIONEER I.2 Only 34 of 122 (28%) of patients treated
weekly with adalimumab achieved this endpoint at week 12 in the
PIONEER I monotherapy study.3 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 9.4 Revuz J. Hidradenitis
suppurativa. J Eur Acad Dermatol Venereol 2009; 23:
985-998.5 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.2008.11.911.6
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 30.7 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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