Targanta initiates PH II oritavancin trial

Massachusetts, USA-based Targanta Therapeutics has initiated a Phase II trial investigating the safety and efficacy of oritavancin at single or infrequent doses for the treatment of complicated skin and skin structure infections (cSSSI), or SIMPLIFI. The drug is Targanta's lead antibiotic candidate targeting gram-positive infections.

This study is an international, multicenter, randomized, double-blind, controlled investigation in patients with cSSSI presumed or proven to be caused by gram-positive pathogen(s). It consists of three treatment arms in which patients will receive either: 200mg oritavancin intravenous daily for a minimum of three days and up to a maximum of seven days (the dosing regimen used in the larger of the two completed Phase III studies of oritavancin in cSSSI); a single dose of 1,200mg oritavancin IV; or a single dose of 800mg oritavancin IV, with a further 400mg IV on day five if needed.

As its primary endpoint, SIMPLIFI will measure clinical response (either cure or improvement versus failure) in clinically-evaluable patients. As a secondary endpoint, this study will examine safety data in all intent-to-treat patients. Targanta expects to enroll a total of 300 patients in this study.