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news.Xytis has enrolled the first patient in its phase II clinical trial with anatibant for the treatment of traumatic brain injury (TBI).
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Phase I clinical trials with anatibant in healthy volunteers and patients with TBI demonstrated a favorable clinical safety, tolerability and pharmokinetic profile, according to the company. Xytis plans to enroll 400 patients with moderate to severe closed head TBI in 9 countries over the next 12 months.
Vincent Simmon, president and CEO of Xytis, said: “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.”
There are no therapeutics for TBI despite the fact that the CDC estimates that in the US there are 1.4 million TBI cases per year of which 50,000 patients die and 235,000 are hospitalized with moderate to severe TBI.