XBiotech Announces First Patient in Phase 2 Study Evaluating Subcutaneous MABp1 in Patients with Hidradenitis Suppurativa
July 10 2018 - 8:00AM
XBiotech Inc. (NASDAQ:XBIT) announced today that the first patient
has been enrolled in its Phase 2 open label, dose escalation
clinical study evaluating the Company’s subcutaneous formulation of
MABp1 in patients with moderate to severe Hidradenitis Suppurativa
(HS). The patient began treatment at Tennessee Clinical Research
Center located in Nashville under the care of Dr. Michael Gold.
Dr. Gold commented, “We are very excited to be
participating with XBiotech in this ground breaking research
endeavor for patients suffering from hidradenitis
suppurativa. We are hopeful that this research will unlock
some of the important keys to successfully treating our
patients.”
XBiotech is developing a human-derived antibody
(MABp1) which neutralizes IL-1 alpha (IL-1⍺), an inflammatory
cytokine that plays a key role in the pathophysiology of a wide
range of inflammatory skin disorders1. Three phase II studies
sponsored by XBiotech have been completed in dermatologic
indications (acne, psoriasis, pyoderma gangrenosum) 2,3.
Results from an investigator sponsored phase 2 study evaluating
MABp1 for the treatment of Hidradenitis Suppurativa were published
in the Journal of Investigative Dermatology with the study meeting
its primary endpoint, demonstrating significant improvement of HS
patients treated with MABp1 compared to control after 12 weeks of
therapy (response rate of 60% vs 10%, respectively (p=0.035)) 4,.
This previous HS study, however, involved intravenous infusion of
the antibody therapy. This will be the first use of the MABp1
subcutaneous formulation in HS, including the use of pre-filled
syringes with a newly developed concentrated formulation of MABp1
for convenient dosing.
For more information on this study, please visit
www.clinicaltrials.gov
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 abscesses5,6. Therefore, HS is often devastating for
patients with significant impact on quality of life 7. The
Dermatology Quality Life Index (DQLI) for HS is 8.9, being higher
than any other skin disorder8. Traditional treatments comprise of
antibiotics, antiandrogens and surgery. The global prevalence for
HS is estimated at up to 4% of the population 2.
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.
2 Coleman KM et al. Open-Label Trial of MABp1, a True Human
Monoclonal Antibody Targeting Interleukin 1α, for the
Treatment of Psoriasis. JAMA Dermatol. 2015
May;151(5):555-6.
3 Carrasco D et al. An Open Label, Phase
2 Study of MABp1 Monotherapy for the Treatment
of Acne Vulgaris and Psychiatric Comorbidity. J Drugs
Dermatol. 2015 Jun;14(6):560-4.
4 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.
5 Revuz J. Hidradenitis suppurativa. J Eur Acad
Dermatol Venereol 2009; 23: 985-998.
6 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.
7 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.
8 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.
XBiotech (NASDAQ:XBIT)
Historical Stock Chart
From Mar 2024 to Apr 2024
XBiotech (NASDAQ:XBIT)
Historical Stock Chart
From Apr 2023 to Apr 2024