Theravance Biopharma, Inc.today announced the presentation of interim data from the Company’s ongoing Telavancin Observational Use Registry (TOUR) study.  TOUR is designed to assess how VIBATIV® (telavancin) is being used by healthcare practitioners to treat patients in real-world settings.  An initial review of data from the first 200 patients enrolled in TOUR demonstrate clinical response rates of 74% in a range of difficult-to-treat infection types including the drug’s approved indications of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) and complicated skin & skin structure infections (cSSSI).  Other serious infections reported to the TOUR database included bone and joint infections and bacteremia.  Results show 17% of all patients were considered non-evaluable with 9% deemed to have failed treatment.  Clinical response was defined as cure or improvement leading to step-down oral therapy.  These interim TOUR results were presented at IDWeek 2016, which was held in New Orleans, LA on October 26 – 30, 2016.

In addition to clinical response, reported data also provide an overview of the types of patients that are receiving VIBATIV treatment in real-world clinical settings.

Most frequent primary infections treated

♦   cSSSI (44%)

♦  bone and joint infections (30%)

♦  bacteremia (13%)

♦  pneumonia (6%)

For these infections, the underlying pathogen was most often identified as methicillin-resistant Staphylococcus aureus (S. aureus) or MRSA (51%), methicillin-susceptible S. aureus or MSSA (15%) and coagulase negative staphylococci (10%).  VIBATIV was generally well tolerated.  Of the 199 patients with safety data, there were 47 adverse events (AE) reported in 34 patients.

“It is noteworthy that we are seeing VIBATIV used in complicated infections such as bone and joint and bacteremia in addition to the product’s labeled indications,” said Adam Bressler, M.D. Partner, Infectious Disease Specialists of Atlanta, Clinical Director of Medical Microbiology, Infection Prevention and Management, and Antimicrobial Stewardship DeKalb Medical Center and the presentation’s lead author.  “It will be interesting to see if these prescribing patterns persist or evolve throughout the remainder of the study and what conclusions can be drawn about these treatment decisions.”

“It is not surprising that a majority of the infections treated to date in TOUR are tied to MRSA as the underlying pathogen.  There is a growing collection of research supporting the in vitro potency of VIBATIV against challenging pathogens such as MRSA and the infections caused by these pathogens remain some of the most difficult to treat,” stated Louis D. Saravolatz, Chairman, Department of Medicine at St. John Hospital and Medical Center and a TOUR study investigator.  “An observational use registry of this type provides us with valuable information on a medicine like VIBATIV by compiling and evaluating the real-world clinical experience of approximately 1,000 patients.  This level of detail, which would not be possible otherwise, can play an important role in helping guide the best use of VIBATIV in the clinical setting.”

“We are pleased with the progress and results that we have seen to date with regard to TOUR.  We have enjoyed a rapid rate of enrollment which now places us ahead of the registry’s projected timeline.  At the same time, we are seeing clinical response rates that are in line with our expectations and comparable to data included in the current VIBATIV label,” said Frank Pasqualone, Senior Vice President and Global Head, Acute Care Business at Theravance Biopharma and Jon Bruss, M.D., Vice President Clinical Development & Medical Affairs at Theravance Biopharma

TOUR is a multi-center, observational study designed to enroll and report the treatment course of approximately 1,000 patients from about 50 sites in the US.  As a non-interventional study, all treatment decisions are at the discretion of the patient’s healthcare provider prior to patient enrollment.  Study patients will have treatment initiated in both hospital-based settings and out-patient infusion sites.  In order to qualify for enrollment in TOUR, patients must have received at least one dose of VIBATIV and meet specified inclusion criteria.  By broadly collecting and examining real-world data related to VIBATIV treatment patterns, clinical effectiveness and safety outcomes in medical practice, Theravance Biopharma aims to create an expansive knowledge base to guide optimal clinical use and future development of the drug. More than 600 of the 1,000 target patients have been enrolled to date.

Theravance Biopharma believes that results from TOUR may serve several important objectives including:

  • Assisting in optimizing use in patients currently being treated with VIBATIV;
  • Assessing the types of patients that are best suited for treatment, potentially highlighting subsets of patients that may be most appropriate for treatment with VIBATIV; and
  • Illustrating current healthcare practitioner’s patterns of VIBATIV use in various infection types.

About VIBATIV® (telavancin)

VIBATIV® was discovered internally in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus (S. aureus) and other Gram-positive bacteria, including MRSA and MSSA. VIBATIV is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with in vitro potency and a dual mechanism of action that both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function. The drug’s proven efficacy against difficult-to-treat Gram-positive infections has been demonstrated in several large, multinational registrational studies, which involved one of the largest cohorts of patients with S. aureus infections studied to date.  Additionally, there is extensive and well-documented evidence of the drug’s in vitro potency and in vivo activity against a broad collection of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant.  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 S. aureus when alternative treatments are not suitable. In addition, VIBATIV is approved in the U.S. for the treatment of adult patients with complicated skin & skin structure infections (cSSSI) caused by susceptible isolates of Gram-positive bacteria, including S. aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains. The product labeling also describes the use of VIBATIV in treating patients with concurrent bacteremia (in addition to either skin infection or pneumonia).

 

VIBATIV is also approved for marketing in Europe, Canada and Russia.  Theravance Biopharma plans to market VIBATIV outside the U.S. through a network of partners. To date, the company has secured partners for VIBATIV in the following geographies – Canada, Middle East, North Africa, Israel, Russia, China and India.