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.
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."