Theravance Study confirms in-vitro potency of telavancin and efficacy in patients with complicated skin infections

SOUTH SAN FRANCISCO, Calif.—Theravance, Inc. announced today 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).

“Theravance is committed to meeting the growing needs of infectious disease physicians, pulmonologists/critical care (PUD/CC) physicians, ID/CC pharmacists, and other relevant healthcare practitioners,” said Frank Pasqualone, senior vice president, operations at Theravance. “The most recent data presented at ECCMID reinforce that VIBATIV is potent in-vitro and an effective alternative antibiotic for MRSA and other difficult-to-treat Gram-positive infections in patients with cSSSI or HABP/VABP. In addition to being non-inferior to vancomycin in its approved indications, VIBATIV is differentiated from vancomycin with regard to in-vitro potency, dosing, convenience and its dual mechanism of action. The range of important study results presented at the ECCMID conference bolsters our belief that VIBATIV is an essential tool in the antibiotic arsenal of physicians and healthcare practitioners.”

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 Staphylococcus aureus when alternative treatments are not suitable, and for the treatment of cSSSI caused by susceptible isolates of Gram-positive bacteria, including Staphylococcus aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains. VIBATIV, discovered and developed by Theravance, is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with in- vitro potency and a dual mechanism of action whereby telavancin both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function.

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.

Importantly, results of the retrospective analysis in a subset of patients from the overall treated 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.

“We thought that something else was going on affecting the results in patients with poor renal function,” opines Steve Barriere, Pharm.D. vice president, clinical and medical affairs at Theravance. “We believe that these new data reconfirm the therapeutic value of VIBATIV and provide physicians a much needed additional option for their patients with infections that are difficult-to-treat, do not respond to alternate treatment options or when these alternative options should not be used,” Barriere adds. “Importantly, we now have a rationale for re-evaluating previous conclusions regarding the impact of renal impairment on clinical response to VIBATIV.”

“In light of the medical and scientific community’s growing concern regarding the increasing prevalence of MRSA and potential for decreasing vancomycin susceptibility, having access to an antimicrobial with the efficacy of VIBATIV (telavancin) is important. The results of this new data analysis, which demonstrates cure rates comparable to vancomycin, position VIBATIV as a vancomycin alternative in serious, acute bacterial soft tissue infection,” stated Samuel Wilson, M.D., professor, Department of Surgery, Division of Vascular & Endovascular Surgery, University of California, Irvine, and a study investigator for the Phase 3 ATLAS clinical trials. “Furthermore, the value of VIBATIV will be enhanced if additional clinical research shows that renal impairment does not result in reduced clinical response to the treatment.”

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. “We’ve tested VIBATIV against thousands of uncommon bugs,” says Barriere, “and it beats vancomycin.” 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.

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.

“As telavancin is re-engineered from vancomycin, there may be the assumption that vancomycin immunoassays can be effectively used to measure blood levels of telavancin. However, there are currently no data to suggest the clinical utility of measuring telavancin concentrations in plasma. Furthermore, we have demonstrated with these study results that use of vancomycin immunoassays produces highly variable results,” said Barriere. “With approved dosing regimens, and appropriate adjustment for renal dysfunction, subsequently achieved concentrations of telavancin are well-defined and predictable.”

VIBATIV 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. The drug is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with in-vitro potency and 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 including ventilator associated pneumonia, known or suspected to be caused by MRSA. VIBATIV should be used only in situations where it is known or suspected that other alternatives are not suitable. VIBATIV is not currently indicated for the treatment of cSSSI in Europe.