Phase 2 study of torezolid for complicated skin and skin structure infections

Trius Therapeutics, Inc. announced results from its Phase 2 clinical trial evaluating the safety and efficacy of oral torezolid (TR-701) for the treatment of severe complicated skin and skin structure infections caused by gram-positive bacteria, especially drug-resistant strains such as methicillin-resistant Staphylococcus aureus (MRSA). This Phase 2 trial was a randomized, double-blind, dose-ranging study conducted at eight centers in the United States. Torezolid was administered to 188 patients at doses of 200mg, 300mg, or 400mg once daily for 5–7 days. Of these patients 164 (87%) were clinically evaluable at the test-of-cure visit. Overall cure rates for severe abscesses, cellulitis, and wound infections were 96%, 97%, and 90%, respectively. Clinical cure rates were 98%, 94%, and 94% for the 200mg, 300mg, and 400mg doses, respectively. In the microbiologically evaluable population (133 patients, 71%), the cure rates were 100%, 93%, and 96% for the 200mg, 300mg and 400mg doses, respectively. MRSA was the primary pathogen in 72% of the microbiologically evaluable patients. At the late follow-up visits 21–28 days post treatment, there were no clinical relapses.

Torezolid is a second-generation oral and IV antibacterial drug in the oxazolidinone class with activity against drug-resistant, gram-positive bacterial pathogens, including those resistant to linezolid. The IV dosage form of torezolid is currently in Phase 1 trials.

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