Positive Phase III results for tedizolid phosphate (Trius Therapeutics) for ABSSSI

Trius Therapeutics, Inc. has announced top-line results from its ESTABLISH 2 Phase III clinical trial of tedizolid phosphate (TR-701) for the treatment of Acute Bacterial Skin and Skin Dtructure Infections (ABSSSI), including methicillin resistant Staphylococcus aureus (MRSA). As in the ESTABLISH 1 study, which tested the oral dosage form of tedizolid, the ESTABLISH 2 intravenous to oral transition study captured the endpoints for ABSSSI established by both the FDA and the European Medicines Agency (EMA).

The randomized, double-blind, placebo-controlled study enrolled 666 patients with ABSSSI. Patients received either 200 mg of tedizolid once a day for six days of treatment plus four days of placebo or 600 mg of linezolid (Zyvox) twice a day for 10 days of treatment.Tedizolid met its primary endpoint of non-inferiority (10% NI margin) to linezolid as measured by a 20 percent or greater reduction in lesion area at 48 to 72 hours after the first infusion of study drug. Tedizolid also met all secondary efficacy endpoints measured at both the end of therapy and post treatment evaluations.