Trius Therapeutics Inc. (TSRX) announced top-line results from its ESTABLISH 2 Phase 3 clinical trial of tedizolid phosphate or TR-701 for the treatment of acute bacterial skin and skin structure infections or ABSSSI, including methicillin resistant Staphylococcus aureus or 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 and the European Medicines Agency or EMA, the company said.
The company noted that it 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.
As in the ESTABLISH 1 study, both tedizolid and linezolid were generally well tolerated in ESTABLISH 2 with drug-related treatment emergent adverse events or 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), the company said.
Looking ahead, the company said it intends to file its NDA for tedizolid as well as initiate a Phase 3 study of tedizolid in patients with severe pneumonia during the second half of this year.
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