Trius Doses First Patient In Antibacterial Phase 2 Trial - TR-701 Tested For Efficacy In Drug Resistant Skin Infections

Main Category: MRSA / Drug Resistance
Also Included In: Clinical Trials / Drug Trials;  Infectious Diseases / Bacteria / Viruses
Article Date: 22 Sep 2008 - 10:00 PDT

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Trius Therapeutics, Inc. announced the initiation of Phase 2 testing of the oral form of its second-generation oxazolidinone antibacterial drug TR- 701. The multicenter trial will test the efficacy, safety and tolerability of once- daily doses of 200, 300 and 400 milligrams of TR-701 in complicated skin and skin structure infections (cSSSI) for five to seven days of treatment.

The study follows the recently completed two-part Phase 1 study that tested the safety, tolerability and pharmacokinetics of TR-701 in single and multiple ascending doses for up to 21 days compared with Zyvox® (linezolid), the only marketed drug of the oxazolidinone class. In addition, separate food effect and microdialysis studies measuring the absorption of TR-701 in the presence and absence of food and the tissue penetration of the drug, respectively, have also been completed.

Results of the Phase 1 trials will be presented at the joint annual meetings of the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and the Infectious Diseases Society of America (IDSA) in Washington, D.C in October 2008.

"Our Phase 1 study results indicate that TR-701 will be a once-daily drug with the potential to offer patients several important advantages over linezolid as well as other marketed drugs," said Philippe Prokocimer, M.D., Chief Medical Officer of Trius. "The intent of Phase 2 will be to validate these observations in a patient population and to select a therapeutic dosing regimen from the three doses being tested."

"The growing epidemic of MRSA in the hospital and community leaves few viable treatment options for patients requiring an oral drug," said Jeffrey Stein, Ph.D., Chief Executive Officer of Trius. "We believe that the once-daily dosing and short course of TR-701 therapy of five to seven days will offer a clinical advantage for patients and a potential pharmaco-economic advantage for insurers and others concerned about the increasing cost of healthcare."

About Trius Therapeutics

Trius Therapeutics is discovering and developing innovative antibacterial drugs for the treatment of infections caused by resistant pathogens. The company's lead drug candidate, TR-701, is a second generation oral and IV oxazolidinone antibiotic with potent activity against drug-resistant Gram-positive bacterial pathogens including those resistant to Zyvox®. Trius has licensed worldwide rights outside of Korea to TR-701 from Dong-A Pharmaceuticals. Trius' pipeline includes two preclinical programs being developed to treat infections caused by Gram negative bacterial pathogens.

Trius Therapeutics