Theravance Biopharma Shares Positive New Data on VIBATIV at CHEST Meeting

Positive preliminary new data yielded by the Telavancin Observational Use Registry (TOUR) study—conducted to explore how VIBATIV (telavancin) is being used by health care practitioners to treat patients in real-world clinical settings—were presented at this year’s CHEST annual meeting in Toronto, Ontario.

VIBATIV—the only “FDA-approved, once-daily in vitro bactericidal antibiotic for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP), or complicated skin and skin structure infections (cSSSI), including methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-sensitive Staphylococcus aureus (MSSA),” was first discovered through a research program dedicated to developing new drugs in response to the growing threat of resistant bacteria, and the hard-to-treat, even life-threatening infections that result from them.

Some of the findings gleaned from the TOUR study focused on 90 registry patients with confirmed lower respiratory tract infections (LRTIs); investigators report that more than half of patients—67.1%—had positive clinical responses to treatment with VIBATIV.

“What is striking about the positive clinical response rates seen in the LRTI patients, is that 80% of these patients had failed at least 1 previous antibiotic treatment regimen, suggesting that they were battling particularly difficult to treat infections,” lead author of the TOUR presentation, Micah A. Jacobs, MD, an infectious disease specialist in Pittsburgh, Pennsylvania, said in the press release.

Furthermore, 15.3% of those patients failed 2 or more prior therapies. Those with missing or undocumented information were not included in the evaluation, leaving 79 patients.

“The median VIBATIV daily dose and duration of treatment were 690 mg and 8 days, respectively,” according to the official press release. More than half of the 79 patients, or 67.1%, showed positive clinical response to VIBATIV; only 19% failed to respond to treatment and 13.9% of evaluable patients were said to have had “an indeterminate outcome.”

The pathogen most responsible for these infections was methicillin-resistant Staphylococcus aureus (MRSA), which was accounted for 52.2% of the infections; however, 22.2% of the evaluated patients had 2 or more pathogens responsible for their infections.

Presenters at the CHEST meeting also shared information pertaining to “adverse (AEs) of interest, which included renal AEs and AEs leading to discontinuation or fatal outcome,” which were noted in 16 patients, according to the press release. Out of the 16 patients, 11 had “serious AEs.” These AEs of interest resulted in the discontinuation of treatment in a total of 12 patients.

Nonetheless, the overall results were positive. “Results from the TOUR study continue to demonstrate consistently positive clinical response rates following VIBATIV treatment across a broad range of infection types,” Dr. Jacobs said. “The overall clinical response rate for LRTIs in TOUR was impressive. These latest findings reinforce the efficacy and safety results observed in the pivotal trials that supported the approval of VIBATIV in HABP and VABP and validate the ongoing use of the antibiotic for patients with Gram