Wyeth Pharmaceuticals, a division of Wyeth, recently presented new phase III data about its investigational antibiotic, tigecycline, based on a clinical trial in patients with complicated intra-abdominal infections (cIAI).
This study compared tigecycline with a current empiric combination treatment for intra-abdominal infections comprised of Primaxinâ (Imipenem and Cilastatin for Injection), a common treatment for such illnesses. Overall, in patients who had a positive culture, the microbiologic eradication rate was 91.3 per cent for tigecycline as a monotherapy treatment versus 89.9 per cent for imipenem/cilastatin, with a similar safety and tolerability profile in the two groups.
"Serious community acquired and hospital infections are a growing public health concern around the globe," says Evan Loh, VP of Cardiovascular/Infectious Disease at Wyeth. "These results are encouraging for the potential empiric, monotherapy use of tigecycline, one of the only new antibiotics currently in development. Once approved, this compound has the potential to have a major impact on the current treatment paradigm against infectious disease around the globe," he added.
Currently, in phase III testing, tigecycline is being investigated to treat a number of infections: cSSSI, cIAI, and hospital-and community-acquired pneumonia, including those caused by multi-drug resistant pathogens. Wyeth plans to file a new drug application (NDA) for tigecycline with the US FDA and a dossier with the European Medicines Agency and other authorities worldwide upon the conclusion of clinical testing.
Several abstracts from the ongoing Tigecycline Evaluation Surveillance Trials (T.E.S.T.), which examined its in vitro activity against a broad-range of bacteria, including some organisms that are resistant to many antibiotics currently available, were also presented. T.E.S.T evaluated the activity against specific bacteria, targeting the most common hospital pathogens, including multiple antibiotic-resistant bacteria.
This study continues to evaluate tigecycline activity against a broad spectrum of pathogens, including methicillin-resistant (and sensitive) Staphylococcus aureus (MRSA and MSSA) and most species of Enterobacteriaceae (Escherichia coli, Enterobacter spp., and Klebsiella spp.).
This new data was presented in a late-breaking abstract at the 44th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington, DC, USA, along with additional data that compared tigecycline to vancomycin/aztreonam to treat complicated skin and skin structure infections (cSSI). A total of twenty-one abstracts on tigecycline were presented at this meeting.