After successful completion of enrollment into the first STRAUSS trial (Study of Resistant Staphylococcus Aureus Skin and Skin Structure Infections), focusing on Gram-positive infections, the partnership now plans to study ceftobiprole in a second complicated skin infection trial by targeting both Gram-positive and Gram-negative bacterial infections, including patients with diabetic foot infections.
Foot ulcers develop in 15% of people suffering from diabetes mellitus, which may evolve to uncontrolled infections requiring lower leg amputation. In the US, 81,000 lower leg amputations occur per year in diabetic patients, and associated health care cost are very significant.
Typically diabetic foot infections are caused by staphylococci (including MRSA) and streptococci, and very often involve also Gram-negative and anaerobic bacteria. Adequate treatment of diabetic foot infections requires hospitalization, urgent surgery and broad-spectrum intravenous antibiotics.
In March 2003, the FDA granted Ceftobiprole a fast track designation for the treatment of complicated skin and skin structure infections due to methicillin-resistant Staphylococcus species.
In June 2004, the FDA granted a fast track designation for a second indication for the treatment of hospital-acquired (nosocomial) pneumonia, including ventilator-associated pneumonia due to suspected or proven methicillin-resistant Staphylococcus aureus (MRSA). Ceftobiprole is currently in phase III clinical trials in complicated skin and skin structure infections and hospital-acquired pneumonia.
“Our joint development plan to maximize the potential of ceftobiprole is being executed as intended. It confirms the high commitment of both parties to this product and the effectiveness of the partnership between our two companies,” commented Dr Anthony Man, Basilea’s CEO.