XBiotech Announces Enrollment Completion Of Phase I Clinical Trial For Hutrukin, A Novel Candidate Therapy For Stroke
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.