In December 2011, we announced that tedizolid phosphate (TR-701) 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.
CE = Clinically Evaluable
Both tedizolid and linezolid were generally well tolerated with comparable overall safety profiles, with drug-related treatment emergent adverse events (TEAE) reported in 24.2% of tedizolid patients versus 31.0% of linezolid treated patients.
*Statistically Significant (p=0.004).
Trius initiated the second Phase 3 trial of tedizolid phosphate in ABSSSI, designated TR701-113, for its intravenous (IV) to oral transition therapy in September of this year and expects to report top-line data in early 2013. The 113 study is the first clinical trial conducted in collaboration with Bayer HealthCare and will recruit patients in North and South America, Europe, Australia, New Zealand, and South Africa.