XBiotech Announces Enrollment Completion of Phase I Clinical Trial for Hutrukin, a Novel Candidate Therapy for Stroke
September 26 2023 - 9:00AM
XBiotech Inc. (NASDAQ: XBIT) Announces that Hutrukin is being
developed by XBiotech as a breakthrough therapy to reduce brain
injury after stroke. The last subject in a randomized, open-label,
placebo-controlled Phase I dose escalation clinical study has been
enrolled. XBiotech discovered, manufactures, and is conducting this
clinical study of Hutrukin.
The primary objective of the Phase I study is to evaluate safety
and pharmacokinetics of Hutrukin in healthy volunteers. Sequential
dose escalation was conducted using three cohorts of subjects, each
receiving a single intravenous infusion of either placebo or
Hutrukin, with eight subjects in each cohort.
Hutrukin is a candidate drug being developed to reduce brain
injury following ischemic stroke. Globally, one in four people over
age 25 will experience a stroke—the leading cause of disability and
second leading cause of death in the world. An ischemic stroke
occurs when a blood clot obstructs a blood vessel that supplies the
blood to the brain. Blockage of blood flow to the brain results in
brain injury, loss of brain function, or death.
Emergency treatment for stroke includes “clot-busting” drugs or
mechanical catheters to re-open arteries, both of which are
associated with a phenomenon known as reperfusion injury.
Reperfusion injury is the damage that occurs to previously healthy
brain tissue after a clot is removed from the artery and blood
supply is returned to the healthy but hypoxic brain tissue. This
secondary damage is believed to be the result of an inflammatory
response resulting from the return of blood cells to the region of
the brain that had been previously deprived of blood and oxygen
(which is the hypoxic brain tissue).
When administered immediately prior to artery-opening
procedures, Hutrukin may reduce the inflammatory injuries
associated with reperfusion. No drug or treatment is currently
available to reduce or prevent reperfusion injury. Hutrukin
potentially represents a unique and major advance for stroke
victims.
About True Human™ Therapeutic Antibodies
XBiotech’s True Human™ antibodies are derived
without modification from individuals who possess natural immunity
to certain diseases. By harnessing the body’s natural immunity to
cure disease, True Human™ antibodies have the potential to
revolutionize medicine.
About XBiotechXBiotech is
dedicated to pioneering the development of breakthrough therapies
derived from natural human immunity. XBiotech discovered genetic
engineering tools that enabled identification of rare antibodies
present in human donor blood, and has built a pipeline of antibody
therapies, including a candidate therapy that could revolutionize
arthritis treatment. Headquartered in Austin, Texas, XBiotech has
also lead innovation in biomanufacturing technology. For more
information, visit www.xbiotech.com.
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Contact
Wenyi Weiwwei@xbiotech.comTel. 512-386-2900
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