The trial will include patients with resistant strains of disease including methicillin-resistant Staphylococcus aureus (MRSA).
“We have enrolled more than 1,800 patients overall and expect to have more than one-third with confirmed MRSA infections at baseline. The design of the phase III program gives us the opportunity to detect clinical superiority of telavancin over vancomycin, in the treatment of patients with MRSA infections, if such superiority exists,” said Dr Michael Kitt, senior vice president of development at Theravance.
Telavancin inhibits the formation of the bacterial cell wall and disrupts bacterial cell membrane integrity. The company said in a statement that it believes the additive mechanisms of action seen with telavancin speed bacterial killing while also reducing the risks of inducing resistance to telavancin or cross-resistance with other antibiotics.
Telavancin is also in phase III clinical studies for the treatment of patients with hospital-acquired pneumonia (HAP).
In November 2005, Theravance entered into a collaboration arrangement with Astellas Pharma for the development and commercialization of telavancin worldwide, except Japan.
Under the terms of the collaboration, Theravance will lead the development of telavancin for the treatment of complicated skin and skin structure infections (cSSSI) and HAP, and will collaborate substantially with Astellas in marketing in the US for the first three years. Astellas will lead all other development, regulatory, manufacturing, sales and marketing activities.
The last clinical visit by the last patient in the cSSSI phase III program will trigger a $25 million milestone payment to Theravance from Astellas.