New Data Analyses From Phase 3 ATTAIN Trials Support VIBATIV(R) (Telavancin) as a Treatment for Staphylococcus Aureus HABP/VABP, Including Cases Caused by MRSA - Seite 2

Additional findings from the post hoc analyses showed that rates of nephrotoxicity were comparable for telavancin and vancomycin treatment with no statistically significant differences. This is noteworthy as the initial analysis of the Phase 3 ATTAIN studies generated results suggesting a potential increased risk of nephrotoxicity in certain patients following treatment with telavancin as compared to vancomycin. 

"The findings pertaining to comparable rates of nephrotoxicity between telavancin and vancomycin are of particular interest to Theravance Biopharma in light of previous conclusions regarding the risk for nephrotoxicity with telavancin treatment," stated Jon Bruss, M.D., Vice President Clinical Development & Medical Affairs at Theravance Biopharma. "We believe that the fact that there were no statistically significant differences in rates of nephrotoxicity between the telavancin or vancomycin treatment provides a rationale for a more careful evaluation of the potential risk of nephrotoxicity associated with telavancin treatment." 

The purpose of the post hoc analyses was to further evaluate and compare the ATTAIN studies' clinical cure rates and safety results for telavancin vs. vancomycin across a range of comorbidities including patient age, type of infection and severity of disease. The analyses were conducted by researchers at Weill Cornell Medical Center/Medical College and Baystate Medical Center (Springfield, Mass), in collaboration with Theravance Biopharma.

About VIBATIV^® (telavancin)

VIBATIV^® was discovered internally in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus (S. aureus) and other Gram-positive bacteria, including MRSA and MSSA. VIBATIV is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with in vitro potency and a dual mechanism of action that both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function. The drug's proven efficacy against difficult-to-treat Gram-positive infections has been demonstrated in several large, multinational registrational studies, which involved one of the largest cohorts of patients with S. aureus infections studied to date. Additionally, there is extensive and well-documented evidence of the drug's in vitro potency and in vivo activity against a broad collection of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant. VIBATIV is approved in the U.S. for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of S. aureus when alternative treatments are not suitable. In addition, VIBATIV is approved in the U.S. for the treatment of adult patients with complicated skin & skin structure infections (cSSSI) caused by susceptible isolates of Gram-positive bacteria, including S. aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains.