XBiotech Announces Completion of U.S. Enrollment in Phase 2 Multicenter Study Evaluating Bermekimab in Patients with Hidraden...
September 24 2018 - 08:30AM
XBiotech Inc. (NASDAQ: XBIT) announced today that it had
completed enrollment in the U.S. for its Phase 2, open label
clinical study evaluating subcutaneous administration of bermekimab
in patients with moderate to severe Hidradenitis Suppurativa (HS).
Enrollment has exceeded the planned limit for the study in just
over two months, significantly outpacing expectations. XBiotech
plans to accept a limited number of additional patients in Europe
prior to study completion.
John Simard, Chairman & CEO of XBiotech,
commented, “We are very pleased by the enrollment rate we have seen
in this study. Patient availability has been well beyond what was
predicted. I believe this speaks to the need for new treatment
options for this debilitating disease. I want to thank all of the
patients and clinical sites for their ongoing participation in this
study.”
The phase 2 study involves a 13-week treatment
regimen. Two groups of patients are being treated with bermekimab:
those who have had and failed prior anti-TNF therapy; and those
with no prior anti-TNF treatment history. Bermekimab was previously
evaluated for treatment of hidradenitis suppurativa in a double
blind, placebo controlled study. In that study, 60% of treated
patients achieved the primary efficacy endpoint, a positive HiSCR,
versus only 10% of patients who had received placebo. Patients were
treated with an intravenous formula of bermekimab. Based on
feedback from key opinion leaders, XBiotech developed and is now
evaluating a subcutaneous formulation in pre-filled syringes that
can be conveniently administered.
About True Human™ Therapeutic
AntibodiesXBiotech’s True Human™ antibodies are derived
without modification from individuals who possess natural immunity
to certain diseases. 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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