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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

t Regional Research Group, Columbus, GA, a clinical investigator of the Phase 2 study. "The nature of such infections usually warrants use of an IV antibiotic, but the trial results indicate that oral torezolid successfully treated these severe infections quickly and effectively."

"We set strict severity criteria for enrollment to ensure that patients had a clear need for systemic antibiotic therapy," said Philippe Prokocimer, M.D., Chief Medical Officer of Trius. "Two-thirds of the patients treated had systemic signs of infection, such as fever or elevated white blood cell counts. The fact that the lowest dose of 200 mg was as efficacious as the higher doses also provides for a broad safety margin. In our prior 21-day Phase 1 clinical trial, which examined hematological parameters as key markers of oxazolidinone safety, the 200 mg dose of torezolid was comparable to placebo while the labeled dose of linezolid produced the expected depletion of platelets and other cell lines. It is also encouraging that the efficacy of the 200 mg dose in patients is consistent with the dose predictions based on animal efficacy studies. Collectively, these data enable us to select the 200 mg dose for our Phase 3 pivotal trials in complicated skin and soft tissue infections."

Torezolid was well tolerated by patients in this Phase 2 trial. Treatment-emergent adverse events related to study drug, 92% of which were assessed as mild, occurred in 35%, 52% and 50% of subjects in the 200, 300 and 400 mg dose groups, respectively. Importantly, there were no study discontinuations due to adverse events. Laboratory results showed no significant shifts from baseline in hematology or chemistry parameters, including platelets or liver enzymes.

"The efficacy and safety of torezolid in this trial demonstrate its potential for the rapid treatment of severe infections caused by Staph aureus, including MRSA, in both the community and the hospit
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SOURCE Trius Therapeutics, Inc.
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