Trius' tedizolid meets in second Phase III ABSSSI trial

Trius Therapeutics Inc. (NASDAQ:TSRX) said once-daily tedizolid met the primary endpoint of non-inferiority to twice-daily Zyvox linezolid in the 666-patient Phase III ESTABLISH 2 (TR701-113) trial to treat acute bacterial skin and skin structure infection (ABSSSI). Specifically, tedizolid was non-inferior to twice-daily Zyvox from Pfizer Inc. (NYSE:PFE) in the proportion of patients with a 20% or greater reduction from baseline in lesion area 48-72 hours after initiation of therapy (85.2% vs. 82.6%). The non-inferiority margin was 10%. Patients initially received the IV formulation of tedizolid or Zyvox, with the option to switch to the respective oral formulations at the discretion of the clinical investigator on or after day two of treatment.

In 2011, Trius reported data from the ESTABLISH 1 (TR701-112) trial showing that once-daily oral tedizolid met the primary endpoint of non-inferiority to twice-daily oral Zyvox in the proportion of patients who achieved cessation of spread of infected lesions and absence of fever at 48-72 hours after initiation of therapy (see BioCentury Extra, Dec. 19, 2011). ...