This phase II study is an international, multi-center, randomized, double- blind, controlled study in patients with complicated skin and skin structure infections (cSSSI) presumed or proven to be caused by gram-positive pathogen(s).
The study consists of three treatment arms in which patients will receive either: 200mg oritavancin IV daily for a minimum of three days and up to a maximum of seven days; a single dose of 1200mg oritavancin IV; or a single dose of 800mg oritavancin IV, with a further dose of 400mg IV on day five if needed.
As its primary endpoint, the trial 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.
“Based on extensive pharmacokinetic and pharmacodynamic modeling, we believe there is a high likelihood of success with the less frequent oritavancin dosing regimens being studied here,” said Pierre Etienne, chief development officer of Targanta.
The US biopharmaceutical company expects to complete collection of data from the trial in the second half of 2008, at which time Targanta will assess whether to pursue Phase III registration trials. In the meantime, the company is working on the preparation of our first US and European regulatory submissions for oritavancin based on the two Phase III cSSSI studies completed to date.”