Milestone for Hutrukin™ Stroke Treatement Candidate

Cohort 2 of XBiotech’s Phase I study for Hutrukin have now completed dosing and safety evaluation. Hutrukin was well tolerated and the study will now begin enrolling subjects into Cohort 3.

Hutrukin is a novel candidate treatment for reducing brain injury after stroke. If a blood clot occurs in an artery supplying blood to the brain, the blocked artery results in loss of blood supply which starves the brain of oxygen (ischemia). The loss of oxygen to the brain as a result of a blot clot is known as an ischemic stroke. Clot-busting drugs and or devices such as catheters have been developed to re-open clogged arteries after a stroke. Surprisingly, however, opening a clogged artery may not reduce the harm from the stroke. In fact, after opening the clot, the return of blood supply to ischemic brain (reperfusion) can result in aggravation of ischemic injury, with a rapid expansion of brain damage.

Hutrukin is being developed as a drug that is given immediately prior to clot-busting procedures, where it is intended to reduce injury associated with reperfusion. There is currently no drug available to treat reperfusion injury. Hutrukin, has the potential to be a novel, breakthrough therapy in the management of ischemic stroke, the second most common cause of death or disability worldwide.

XBiotech is conducting a Phase I study to evaluate safety and pharmacokinetics of Hutrukin in healthy volunteers. The study involves sequential dose escalation, using three groups (or cohorts) of subjects, receiving a single intravenous infusion of either placebo or Hutrukin at 1,000 mg (Cohort 1), 3,000 mg (Cohort 2), or 5,000 mg (Cohort 3) dose levels, respectively. Dose escalation will utilize a 6+2 design with sentinel dosing and doses will be explored with 8 subjects in each cohort (6 subjects are dosed with Hutrukin and 2 subjects with placebo).