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

Trius Therapeutics, Inc. TSRX 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 (MAA) with the European Medicines Agency (EMA). 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 (ITT) analysis set, tedizolid achieved the primary objective of non-inferiority (10% non-inferiority margin) to linezolid in the primary and secondary efficacy endpoints.