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news.Targanta Therapeutics has completed enrollment in its 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.
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This Phase II study is a multi-center, randomized, double-blind, controlled study in patients with complicated skin and skin structure infections (cSSSI) presumed to be caused by gram-positive pathogens. The study consisted of three treatment arms in which patients received either – 200mg oritavancin delivered by intravenous (IV) administration 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 study is measuring clinical response in clinically evaluable patients. As a secondary endpoint, this study is examining safety data in all intent-to-treat patients. Over 300 patients were enrolled in the study.
Mark Leuchtenberger, president and CEO of Targanta, said: “We are optimistic that we will have data ready to submit to one of the major infectious disease meetings this fall and will be using these data to determine whether to pursue Phase III registration trials for infrequent dosing of oritavancin in the treatment of cSSSI.”