Theravance Biopharma, Inc. today announced that new preliminary data from the ongoing Telavancin Observational Use Registry (TOUR) study are the focus of three poster presentations at the 27th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).

Image/James Gathany
Image/James Gathany

TOUR, which has enrolled its target of 1,000 patients, 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 with diagnoses of complicated skin & skin structure infections (cSSSIs), bone and joint infections, or lower respiratory tract infections (LRTIs), report positive clinical responses for VIBATIV treatment ranging from 58.3% to 75.3% in these infection types. Positive clinical response was defined as cure or improvement leading to step-down oral therapy. The Company plans to present additional collections of data from the ongoing TOUR study at appropriate upcoming scientific conferences. The 27th ECCMID is being held in Vienna, Austria, April 22-25, 2017.

The TOUR findings being reported at ECCMID are based on a review of preliminary data collected from the 593 patients that were enrolled in the registry as of September 30, 2016. The Company expects future TOUR analyses to be updated as additional data becomes available and the study is completed. Details from the three TOUR-related ECCMID presentations are as follows:

Complicated Skin and Skin Structure Infections (cSSSIs):

Researchers presented preliminary data reported for 279 patients captured in the TOUR study with confirmed cSSSIs. 62% of patients had been previously treated with other agents unsuccessfully. Positive clinical response was reported for 75.3% of these patients, with 9.3% of patients failing treatment and 15.4% considered non-evaluable. The predominant subtypes of cSSSIs included cellulitis (50.5%), abscess (22.2%), and surgical wound (15.4%), while the underlying pathogens causing the infections included methicillin-resistant Staphylococcus aureus (S. aureus) or MRSA (30.1%), methicillin-susceptible S. aureus or MSSA (9.3%), and coagulase negative staphylococci (6.5%). For these patients, the median VIBATIV daily dose and duration of treatment were 750 mg and 10 days, respectively. Outpatient treatment was reported in 60.9% of the patients. VIBATIV was generally well tolerated in these patients with adverse event type and frequency comparable to those reported in previous clinical trials.

Bone and Joint Infections:

Researchers presented preliminary data reported for 174 patients captured in the TOUR study with confirmed bone and joint infections. 72.4% of patients had been previously treated with other agents unsuccessfully. Positive clinical response was reported for 68.4% of these patients, with 10.3% of patients failing treatment and 21.3% considered non-evaluable. The underlying pathogens causing the infections included MRSA (40.2%), MSSA (13.8%), and coagulase negative staphylococci (6.3%). For these patients, the median VIBATIV daily dose and duration of treatment were 750 mg and 26 days, respectively. Outpatient treatment was reported in 61.5% of the patients. Of the 174 patients, 33 patients had at least one adverse event and seven patients had at least one serious adverse event. There were three deaths within 28 days of the first VIBATIV dose and 20 patients discontinued treatment due to an adverse event.

“Bone and joint infections are one of those challenging infection types in which we are interested, particularly when those are caused by MRSA or MSSA,” said Charles R Sims, M.D., an infectious disease specialist at Baylor CHI St. Luke’s Health, The Woodlands, Texas, and lead author of one of the TOUR presentations at ECCMID. “One of the most exciting elements of the TOUR study is the opportunity to examine real-world prescribing trends and clinical outcomes for VIBATIV in difficult-to-treat infection types. We are encouraged to observe that more than 68% of bone and joint infection patients enrolled in TOUR have experienced a positive clinical response to VIBATIV treatment.”

Lower Respiratory Tract Infections (LRTIs):

Researchers presented preliminary data reported for 36 patients captured in the TOUR study with confirmed LRTIs. 77.8% of patients had been previously treated with other agents unsuccessfully. Positive clinical response was reported for 58.3% of these patients, with 13.9% of patients failing treatment and 27.8% considered non-evaluable. The predominant subtypes of LRTIs were hospital-acquired bacterial pneumonia or HABP (44.4%) and ventilator-associated bacterial pneumonia or VABP (13.9%), while the most common underlying pathogen causing the infections was MRSA (61.1%). For these patients, the median VIBATIV daily dose and duration of treatment were 750 mg and 9 days, respectively. Of the 36 patients, eight patients had at least one adverse event and four patients had at least one serious adverse event. There were six deaths within 28 days of the first VIBATIV dose and two patients discontinued treatment due to an adverse event.

“Despite a majority of the LRTIs in the TOUR study being caused by MRSA, one of the most difficult-to-treat pathogens in the medical field, treatment with VIBATIV delivered a positive clinical response in more than 58% of all LRTI patients,” stated Dino Delaportas, M.D., an infectious disease specialist at Monongalia General Hospital in Morgantown, West Virginia, and lead author of one of the TOUR presentations at ECCMID. “Importantly, these LRTIs spanned HABP and VABP, for which VIBATIV is currently approved, as well as other infection types such as community-acquired pneumonia, lung abscess, and cystic fibrosis exacerbations, among others. The ability to combat this broad range of challenging infections highlights the effectiveness of VIBATIV as an antibiotic treatment against Gram-positive bacteria.”

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