Enrollment of the first patient is expected this month. Werner Tschollar, chief medical officer of Xytis, said: “We are working with the London School of Hygiene and Tropical Medicine (LSHTM), which conducted the largest clinical study in traumatic brain injury (TBI) to date. In that trial, over 10,000 patients were enrolled.”
The trial will be conducted in 19 centers in 11 countries and is expected to enroll 400 patients by Q1 2008. Patients with moderate to severe TBI will receive one of three doses of Anatibant or placebo for five days. Endpoints for the trial include safety and tolerability, mortality as well as functional assessment at days six and 15 post-injury.
Anatibant is a small molecule bradykinin B2 receptor antagonist that has been shown to be safe and effective in animal models of TBI. There are no drugs that have been shown to be effective in treating TBI to date.