Multiple studies of Vibativ in real world settings for infections in obese or elderly patients.- Theravance BioPharma

Theravance Biopharma, Inc.announced that positive new data from multiple studies of Vibativ (telavancin) were presented at the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), which is being held in Madrid, Spain on April 21 � 24, 2018. Two presentations were made reporting new data from the Telavancin Observational Use Registry (TOUR) study, which is designed to report how Vibativ (telavancin) is being used by healthcare practitioners to treat patients in real-world clinical settings. The presented findings, which focus on data from registry patients classified as elderly or obese, report positive clinical responses for Vibativ treatment ranging from 76.5% to 78.8% in these patient subgroups. Positive clinical response was defined as cure or improvement leading to step-down oral therapy.

The TOUR findings reported at ECCMID are based on a review of data collected from the fully enrolled registry of 1,063 patients. The Company expects future TOUR analyses to be updated as additional data become available. Details from the two TOUR-related ECCMID presentations are as follows: 1. Obese Patients in TOUR: Researchers presented data reported for 507 patients in the TOUR study classified as obese (body mass index greaater than 30 kg/m2). The infection types reported for these patients included complicated skin & skin structure infections (cSSSIs) (53.6%), bone and joint infections (27.8%), bacteremia and endocarditis (9.9%), and lower respiratory tract infections (5.1%). Of these patients, 72.2% failed treatment with initial antibiotic therapy prior to receiving Vibativ. Among the patients who had an outcome assessment at end of therapy (EOT) with Vibativ (n = 458), 78.8% were cured or improved to step-down therapy, 9.2% failed treatment and 12.0% had an indeterminate clinical outcome. The median Vibativ daily dose and duration of treatment were 7.3 mg/kg and 11 days, respectively. Of the 507 patients, 82 reported an adverse event. Renal failure, the most commonly occurring adverse event, was reported in 28 of the 507 patients and resolved in the majority of these cases. There were no new safety signals identified in this patient subset.

"Obese patients are an interesting TOUR study subgroup as data show that obesity is a risk factor for developing complicated skin & skin structure infections that are associated with MRSA. Highlighting this increased risk is the fact that more than half of the obese patients in TOUR presented with a complicated skin & skin structure infection," said Adnan Siddiqui, M.D., an infectious disease expert at BJC Christian Northeast Hospital in St Louis and lead author of one of the TOUR presentations at ECCMID. "The nearly 80% positive clinical response rate achieved with Vibativ therapy in the obese patient subgroup is encouraging, particularly considering more than 70% of obese patients in TOUR received Vibativ after failing treatment with an initial antibiotic."

2. Elderly Patients in TOUR: Researchers presented data reported for 312 patients in the TOUR study classified as elderly (greater than 65 years of age). The infection types reported for these patients included cSSSIs (47.4%), bone and joint infections (26.0%), bacteremia and endocarditis (17.3%), and lower respiratory tract infections (9.6%). Of these patients, 67.3% failed treatment with initial antibiotic therapy prior to receiving Vibativ Among the patients that had an outcome assessment at EOT with Vibativ (n = 289), 76.5% were cured or improved to step-down therapy, 11.8% failed treatment and 11.8% had an indeterminate clinical outcome. The median Vibativ daily dose and duration of treatment were 8.3 mg/kg and 10 days, respectively. Of the 312 patients, 55 reported an adverse event. Renal failure, the most commonly occurring adverse event, was reported in 25 of the 312 patients and resolved in the majority of these cases. There were no new safety signals identified in this patient subset.

"Due to the chronic comorbidity commonly associated with the elderly population, this group is at an elevated risk of acquiring serious infections such as those reported in the TOUR study. Accordingly, there is significant value in using an antibiotic against challenging infections that is highly effective at either curing elderly patients or improving their condition enough to allow step-down therapy," said Jeremy Storm, an infectious disease expert at Rapid City Medical Center in South Dakota, D.O., and lead author of one of the TOUR presentations at ECCMID. Vibativ was able to deliver a positive clinical response rate for more than 75% of these patients against a range of challenging infection types."

Activity Against Challenging Gram-Positive Clinical Isolates: In addition to data collected as part of the TOUR study, researchers also presented results from a third study evaluating the in vitro activity of several antibiotics, including Vibativ, against 24,408 Gram-positive clinical isolates collected from medical centers around the world from 2015-2017. 100% of the evaluated S. aureus isolates were susceptible to Vibativ as measured by the FDA-approved breakpoint, regardless of their type or resistance profile, including those considered to be multidrug-resistant (MDR). Vibativ possessed greater in vitro activity than vancomycin, daptomycin and linezolid demonstrated by minimum inhibitory concentrations (MICs) that were 8- to 32-fold lower than for those other antibiotics against all the S. aureus isolates tested, including MDR MRSA. Vibativ maintained potent in vitro activity against ceftaroline-nonsusceptible S. aureus, MDR coagulase-negative staphylococci, beta-haemolytc streptococci and Streptococcus pneumoniae isolate subsets. MICs are a measure used to express in vitro activity of an antibiotic against a pathogen..