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Trius Announces Positive Results From Phase 2 Clinical Trial of Torezolid in Patients With Complicated Skin and Skin Structure Infections
Date:6/8/2009

Second Generation Oxazolidinone Demonstrates Safety and Efficacy with Once-Daily, 200 milligrams (mg) Dosing over Five to Seven Days of Treatment

SAN DIEGO, June 8 /PRNewswire/ -- Trius Therapeutics, Inc. today announced results from its Phase 2 clinical trial evaluating the safety and efficacy of oral torezolid (TR-701), its investigational antibiotic for the treatment of severe complicated skin and skin structure infections (cSSSI) caused by gram-positive bacteria, especially drug-resistant strains such as methicillin-resistant Staphylococcus aureus (MRSA). The study achieved its primary goals of establishing safety and efficacy in all doses evaluated.

In the randomized, double-blind, dose-ranging study conducted at eight centers in the U.S., torezolid was administered orally at doses of 200, 300 or 400 mg once-daily for five to seven days of treatment. Of the 188 patients who received drug, 164 (87%) were clinically evaluable at the test-of-cure visit. The overall cure rates of clinically evaluable patients for severe abscesses, cellulitis and wound infections were 96%, 97% and 90%, respectively. Clinical outcomes were not affected by the size of lesions. Clinical cure rates by dose in the clinically evaluable population were 98%, 94% and 94% for the 200, 300 and 400 mg doses, respectively. In the group of microbiologically evaluable patients (133, 71%), clinical cure was achieved in 100%, 93% and 96% of patients receiving 200, 300 or 400 mg doses, respectively. There were no clinical relapses at the late follow-up visit 21-28 days post treatment. Highlighting the growing problem of drug resistance in the community, MRSA was the primary pathogen in 72% of the microbiologically evaluable patients.

"I was impressed by the rapid clinical effect of oral torezolid in curing severe skin infections caused by MRSA and other gram-positive pathogens," said Dr. Joseph Surber, Chief Medical Officer, Southeas
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SOURCE Trius Therapeutics, Inc.
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