(By Balaseshan) Trius Therapeutics Inc. (NASDAQ: TSRX) said it has completed enrollment of 658 patients in the last of its two phase 3 clinical trials of tedizolid phosphate (TR-701) for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
The trial, designated ESTABLISH 2, examines the efficacy and safety of a six-day course of tedizolid administered once a day versus a 10-day course of linezolid (Zyvox) administered twice a day in patients recruited across sites in North and South America, Europe, Australia, New Zealand and South Africa.
For both tedizolid phosphate and linezolid, drug was initially administered as an intravenous (IV) infusion with the option to switch to oral therapy after the initial day of therapy.
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Last year, Trius completed its ESTABLISH 1 study, testing the oral dosing of tedizolid under the same trial design and endpoints as in ESTABLISH 2. The trial achieved all primary and secondary efficacy outcomes and showed significant safety and tolerability improvements versus linezolid.
The company said as with its ESTABLISH 1 study, ESTABLISH 2 was designed to prepare tedizolid for registration globally by capturing both the new and former FDA endpoints as well as the European endpoints for ABSSSI.
"We remain on schedule to report top-line results from this study in early 2013. The tedizolid clinical program reflects our commitment to bring safe, well-tolerated and convenient therapies to people with life-threatening infections," said Jeffrey Stein, President and Chief Executive Officer at Trius.
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