Date: 2014-05-09
Type of information:
phase: 3
Announcement: presentation of results at the ECCMID conference
Company: Theravance (USA)
Product: Vibativ® (telavancin)
Action
mechanism: Vibativ® (telavancin) was discovered by Theravance in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus and other Gram-positive bacteria, including MRSA. This bactericidal, once-daily, injectable lipoglycopeptide antibiotic with in vitro potency has a dual mechanism of action whereby telavancin both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function. Vibativ®is approved in the U.S. for the treatment of adult patients with HABP/VABP when alternative treatments are not suitable and for cSSSI caused by susceptible isolates of Gram-positive bacteria, including Staphylococcus aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains. In Europe , Vibativ® is indicated for the treatment of adults with nosocomial pneumonia (NP) including ventilator associated pneumonia, known or suspected to be caused by MRSA. Clinigen Group holds the commercial rights to market and distribute Vibativ® in Europe .
Disease: complicated skin and skin structure infections (cSSSI) including methicillin-resistant Staphylococcus aureus (MRSA)
Therapeutic area: Infectious diseases
Country:
Trial details:
Latest
news: * On May 9, 2014, Theravance announced new data from multiple studies of Vibativ® (telavancin). These study results, which offer new insight into the product\'s in vitro potency, efficacy and safety, will be the focus of multiple presentations over the next several days at the 24th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Barcelona, Spain. Combined, the data presentations confirm the in vitro potency of Vibativ® and its efficacy in patients with complicated skin and skin structure infections (cSSSI) including methicillin-resistant Staphylococcus aureus (MRSA).
A retrospective analysis of the Company\'s Phase 3 ATLAS studies in cSSSI (newly classified by FDA as Acute Bacterial Skin and Skin Structure Infections or ABSSSI) will be highlighted in an oral presentation at the ECCMID conference. Results demonstrate the non-inferiority of Vibativ® as compared to vancomycin using new guidance issued by FDA for assessing clinical response in ABSSSI patients. Additionally, Vibativ® was shown to provide improved clinical response as compared to vancomycin when evaluated at certain time points following treatment. Results of the retrospective analysis in a subset of patients from the overall treated (AT) population did not detect the same association between lower response rates in patients with severe renal impairment as did the original Phase 3 analysis. This finding suggests that factors other than Vibativ®\'s efficacy may have been responsible for the lower response rates seen in the original analysis and provides a rationale for further research into understanding the impact of renal dysfunction on clinical response to Vibativ®.
Results of two separate studies to be highlighted in poster presentations at ECCMID demonstrate the potent in vitro activity of Vibativ® across a range of clinical pathogens utilizing a revised susceptibility test method. The new testing methodology for Vibativ® was established to provide more reliable and reproducible susceptibility results. Using the new test, researchers confirmed the previously demonstrated in vitro potency of Vibativ® against various uncommon clinical pathogens from hospitals worldwide, as well as common clinical isolates from European hospitals.
Vancomycin Immunoassays are Highly Variable in Measuring Telavancin Concentrations
A multi-site study assessed the ability of various currently available and commonly used vancomycin immunoassays to measure therapeutic drug levels of telavancin. Study results, to be highlighted in a poster presentation, show that none of the seven tested immunoassays were capable of accurately or consistently measuring telavancin plasma concentrations (levels of cross-reactivity ranged from < 1% to ~30-40%).
