Wyeth shows new Phase III data about its investigational antibiotic, tigecycline

Nov 4 2004

Wyeth Pharmaceuticals recently presented exciting 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 Primaxin (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 percent for tigecycline as a monotherapy treatment versus 89.9 percent for imipenem/cilastatin, with a similar safety and tolerability profile in the two groups.

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, U.S.A., 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.

"Serious community acquired and hospital infections are a growing public health concern around the globe," says Evan Loh, M.D., Vice President 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."

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 U.S. Food and Drug Administration (FDA) and a dossier with the European Medicines Agency and other authorities worldwide upon the conclusion of clinical testing.