Oritavancin is Targanta’s lead antibiotic candidate targeting gram-positive organisms, including methicillin-resistant Staphylococcus aureus, or MRSA.
Oritavancin, administered in a single or in an infrequent dosing regimen, demonstrated comparable efficacy and safety to a three-to-seven day course of oritavancin therapy, as administered in two previously conducted Phase III clinical trials for the treatment of complicated skin and skin structure infections (cSSSI). Each of these Phase III clinical trials met their primary endpoint.
These top-line efficacy results from Simplifi are said to be consistent with Targanta’s previously published preclinical studies. The Simplifi trial was designed based on oritavancin’s unique pharmacokinetic profile and demonstrated concentration-dependent bactericidal activity.
Results of the Phase II Simplifi trial will be used to design a Phase III study to assess the benefits and risks of a single-dose regimen for the treatment of cSSSI. Targanta expects full data from Simplifi will be presented prior to the end of 2008.
Mark Leuchtenberger, president and CEO of Targanta, said: “With the Simplifi results in hand, we will begin to design a larger confirmatory trial that could demonstrate oritavancin’s potential as the market’s first effective single or infrequent intravenous treatment of cSSSI caused by gram-positive bacteria.”