Trius Reports Positive Results From First Phase 3 Trial of Tedizolid in Acute Bacterial Skin and Skin Structure Infections

Trius Therapeutics, Inc.

announced today that tedizolid phosphate met the primary objective of non-inferiority for the efficacy outcome of early clinical response versus the comparator linezolid (Zyvox®) in patients with acute bacterial skin and skin structure infections (ABSSSI). Tedizolid also met all secondary efficacy outcomes in this first of two pivotal Phase 3 trials that were designed to support the filing of a New Drug Application (NDA) with the FDA as well as a Marketing Authorization Application (

) with the European Medicines Agency (

). The pivotal Phase 3 trial, designated TR701-112, examined the efficacy and safety of a once daily 200 milligram dose of oral tedizolid phosphate over a 6-day course of therapy (followed by four days of placebo) versus a twice daily 600 milligram dose of oral linezolid over a 10-day course of therapy in 667 patients recruited across sites in North America, South America and Europe. In the Intent to Treat (

) analysis set, tedizolid achieved the primary objective of non-inferiority (10% non-inferiority margin) to linezolid in the primary and secondary efficacy endpoints.