THERAVANCE REPORTS ADDITIONAL RESULTS FROM CSSSI STUDIES

Theravance has announced additional results from its ATLAS 1 and ATLAS 2 studies assessing the safety and efficacy of telavancin, a rapidly bactericidal injectable antibiotic with multiple mechanisms of action, in the treatment of complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria.

ATLAS 1 and ATLAS 2 were two large, multi-center, multinational, double-blind, randomized Phase III clinical studies that enrolled and treated 1,867 patients in total, 719 of whom were infected with methicillin-resistant Staphylococcus aureus (MRSA).

In the combined studies, patients with cSSSI were randomized to receive either telavancin 10 mg/kg IV once daily or vancomycin 1 gm IV q 12hr (dosages adjusted per site-specific guidelines) for seven to 14 days. Evaluations of efficacy were performed at a follow-up visit that occurred seven to 14 days following the end of treatment. Of the patients enrolled and treated, approximately 80 percent were clinically evaluable, and approximately 70 percent were microbiologically evaluable. Mean age of the patients was approximately 49 years, and 25 percent of patients were diabetic and 12 percent had moderate to severe renal insufficiency at baseline. Approximately 80 percent of the patients had a major abscess or deep, extensive cellulitis. Staphylococcus aureus was the most common baseline pathogen with the majority of the isolates being methicillin-resistant strains.

The primary efficacy endpoint of non-inferiority in the clinical cure rate at the follow-up visit, comparing telavancin to vancomycin, was achieved in both studies, and the rates of clinical cure, microbiological eradication and overall therapeutic response for telavancin compared favorably to those for vancomycin. In the combined data from both studies in patients with MRSA, clinical cure rates, microbiologic eradication rates and overall therapeutic response favored telavancin over vancomycin.