Phase III Study Examines Activity of Tigecycline in Patients With Serious Intra-Abdominal Infections

MADISON, N.J. -- 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 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, along with additional data that compared tigecycline to vancomycin/aztreonam to treat complicated skin and skin structure infections (cSSI).  A total of 21 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, MD, 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.

Additional Meeting Highlights:

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.).

Treating Serious Infections in Hospitals

Physicians around the world face an increasing clinical challenge because current practices to prevent and control antimicrobial resistance in the hospital and community are not working.  This issue is compounded by the fact that few broad-spectrum antibiotic agents are currently in development to fight existing and emerging, resistant bacteria. This increasing antibiotic resistance in the hospitals can lead to treatment failure, negative patient outcomes and increased cost. In fact, published studies suggest that there is a 1.3 to two-fold increase in mortality, morbidity and cost for patients with antibiotic resistant versus susceptible infections.

ICAAC Symposium:

During a symposium offered by ICAAC, entitled: Old Antimicrobials: Deja-vu All Over again, Dr. Evan Loh, vice president of cardiovascular/infectious disease at Wyeth, spoke to physicians and discussed the importance of investigating the development of new antibiotic classes. In his presentation, entitled: Glycylcyclines: Re-Engineering Tetracycline to Meet Todays Rapidly Changing Pathogen Landscape, Loh talked about the glycylcycline class of antibiotics discovered by Wyeth scientists and how excited the company is to be able to help clinicians in the fight against serious infections.


Source: Wyeth Pharmaceuticals