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Tedizolid Met All Primary and Secondary Efficacy Outcomes Designated by the FDA and EMA
NDA Filing Expected Second Half of This Year
SAN DIEGO, March 25, 2013 (GLOBE NEWSWIRE) -- Trius Therapeutics, Inc. (Nasdaq:TSRX) today announced top-line results from its ESTABLISH 2 Phase 3 clinical trial of tedizolid phosphate (TR-701) for the treatment of acute bacterial skin and skin structure 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 (IV) to oral transition study captured the endpoints for ABSSSI established by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Trius conducted the trial at 95 sites in North and South America, Europe, Australia, New Zealand and South Africa. 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. Patients initially received the IV dosage form of either tedizolid or linezolid with the option to switch to the respective oral dosage forms at the discretion of the clinical investigator on or after the second day 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.
ITT Analysis Set
Tedizolid 6 days treatment, % (n = 332)
Linezolid 10 days treatment, % (n = 334)
Treatment Difference (95% CI), %
≥20% decrease from baseline in lesion area at 48-72 hours
2.6 (-3.0 to 8.2)
Key Secondary Endpoints
Sustained clinical response at end of therapy
-1.0 (-6.1 to 4.1)
Investigators assessment of clinical response at 7-14 days after end of therapy
0.3 (-4.8 to 5.3)
Sensitivity analysis (2010 FDA guidance)
Cessation of spread and absence of fever at 48-72 hours
4.4 (-1.2 to 10.1)
As in the ESTABLISH 1 study, both tedizolid and linezolid were generally well tolerated in ESTABLISH 2 with drug-related treatment emergent adverse events (TEAE) reported in 20.5% of tedizolid patients versus 24.8% of linezolid treated patients. Gastrointestinal adverse events were the most commonly reported of all TEAEs (16.0% in tedizolid vs. 20.5% in linezolid).