September 22, 2008
Trius Initiates Dosing in Phase II Study of Oral Antibacterial Drug
Trius Therapeutics has initiated a Phase II 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 400mg 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 I 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.
Philippe Prokocimer, chief medical officer of Trius, said: "The intent of Phase II will be to validate these observations in a patient population and to select a therapeutic dosing regimen from the three doses being tested."
Jeffrey Stein, CEO of Trius, said: "The growing epidemic of methicillin-resistant Staphylococcus aureus in the hospital and community leaves few viable treatment options for patients requiring an oral drug. 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 pharmacoeconomic advantage for insurers and others concerned about the increasing cost of healthcare."