XYTIS BEGINS ENROLLMENT IN BRAIN INJURY STUDY

Xytis has begun enrolling patients in a Phase II clinical trial of Anatibant for the treatment of traumatic brain injury (TBI).

The company said it plans to enroll 400 patients with moderate to severe closed-head TBI in nine countries over the next 12 months into the BRAIN trial. Patients will receive one of three doses of Anatibant or placebo for five days. The study's endpoints include safety and tolerability, mortality and functional assessment at six and 15 days after injury.

Anatibant is a selective, potent, small-molecule Bradykinin B2 receptor antagonist that has been shown to be safe and effective in animal models of TBI.

Phase I clinical trials of Anatibant in healthy volunteers and patients with TBI have demonstrated a favorable clinical safety, tolerability and pharmokinetic profile. The drug is 1,000 times more potent than Bradycor, the compound used in a previous TBI study, and has a much better pharmacodynamic profile, according to the company.

According to the company, there are currently no approved treatments for TBI, even though the Centers for Disease Control and Prevention estimates that in the U.S. there are 1.4 million TBI cases every year.