26.09.2023 15:00:05 - dpa-AFX: GNW-Adhoc: XBiotech Announces Enrollment Completion of Phase I Clinical Trial for Hutrukin, a Novel Candidate Therapy for Stroke
AUSTIN, Texas, Sept. 26, 2023 (GLOBE NEWSWIRE) -- 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(TM) Therapeutic Antibodies
XBiotech's True Human(TM) 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(TM) antibodies have the
potential to revolutionize medicine.
About XBiotech
XBiotech 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 (http://www.xbiotech.com).
Cautionary Note on Forward-Looking Statements
This 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.
Contact
Wenyi Wei
wwei@xbiotech.com
(https://www.globenewswire.com/Tracker?data=sS3hFaZhJwZdFvQATY6pum-
AhHNSqDbpxqJKwGBEIownBswLjyVJRRMWhb9PZR0xJEFzCsz3fX-UyF3cgM8AdQ==)
Tel. 512-386-2900
Â