Trius Therapeutics Closes Enrollment in Second Phase 3 Trial of Tedizolid
Trius Therapeutics, Inc. (Nasdaq: TSRX), a biopharmaceutical company focused on the discovery and development of innovative antibiotics for life-threatening infections, announced today that it has reached its enrollment objective 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 pivotal Phase 3 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.
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.
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