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Trius Completes Enrollment in Phase 2 Clinical Trial Evaluating Torezolid (TR-701) in Patients With Complicated Skin and Skin Structure Infections
Date:1/25/2009

180 Patient Trial of 2nd Generation Oxazolidinone Enrolls in Four Months

SAN DIEGO, Jan. 26 /PRNewswire/ -- Trius Therapeutics, Inc. today announced the completion of enrollment in its randomized, double-blind Phase 2 clinical trial testing the oral dosage form of torezolid (also known as TR-701) in patients with complicated skin and skin structure infections (cSSSI). The trial, which was conducted in 12 clinical sites in the United States, examined the efficacy and safety of three dosage strengths of torezolid administered orally once daily over a 5-7 day course of treatment. Top line results of the Phase 2 trial are expected in the second quarter of this year.

"The rapid enrollment in this trial is not only a testimony to the diligence and competence of our clinical investigators and colleagues, but is also an indicator of the increasing prevalence of bacterial infections caused by MRSA in our hospitals and communities and the potential for an oral drug to confront this epidemic," said Philippe Prokocimer, M.D., Chief Medical Officer of Trius. "Over 90% of the pathogens infecting patients enrolled in our Phase 2 trial were Staphylococcus aureus, of which nearly 70% were MRSA. Oral torezolid appears well tolerated and effective as a once-daily therapy to quickly eradicate MRSA and other Gram-positive bacteria causing complicated skin infections."

"Having initiated Phase 1 testing of torezolid in January of 2008, it is very encouraging to have advanced the program through Phase 2 enrollment in approximately one year," said Jeffrey Stein, Ph.D., Chief Executive Officer of Trius. "We aim to continue this momentum and advance the intravenous dosage form of torezolid through Phase 1 testing this year and to initiate Phase 3 testing of both the intravenous and oral dosage forms shortly thereafter. Our goal is to offer patients and physicians a 'best-in-class' therapeutic option to address the growing unmet need for safe and effective treatments for drug resistant bacterial infections in the hospital and in the community."

About Trius Therapeutics

Trius Therapeutics is discovering and developing innovative antibacterial drugs for the treatment of infections caused by drug-resistant pathogens. The company's lead drug candidate, torezolid, is a second generation oral and IV oxazolidinone antibiotic with potent activity against drug-resistant Gram-positive bacterial pathogens including those resistant to Zyvox(R), the only marketed antibacterial drug of the oxazolidinone class. Trius has licensed worldwide rights outside of Korea to torezolid from Dong-A Pharmaceuticals. Trius' pipeline includes two preclinical programs with lead candidates being developed to treat serious infections caused by Gram-negative bacterial pathogens. For more information, visit www.triusrx.com.


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