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Theravance completes enrollment in phase 3 clinical program with antibiotic telavancin
By Lisa Kerner
Erie, Pa., May 16 - Theravance, Inc. said it has enrolled the last of more than 1,800 patients in its first phase 3 clinical program with the investigational antibiotic telavancin.
Study subjects are patients with complicated skin and skin structure infections (cSSSI) due to Gram-positive bacteria, including resistant strains such as methicillin-resistant Staphylococcus aureus (MRSA).
"The design of the phase 3 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," senior vice president of development Michael Kitt said in a company news release.
Telavancin is a rapidly bactericidal, injectable antibiotic with multiple mechanisms of action discovered at Theravance, officials said. It inhibits the formation of the bacterial cell wall and disrupts bacterial cell membrane integrity, believed to speed bacterial killing while reducing the risks of telavancin-resistance or cross-resistance with other antibiotics.
Theravance has a collaboration with Astellas Pharma Inc. to develop and commercialize telavancin worldwide, except Japan. Under this agreement, Theravance will lead the development of telavancin for the treatment of cSSSI and HAP and collaborate with Astellas in U.S. marketing for the first three years.
The last clinical visit (test-of-cure visit) by the last patient in the cSSSI phase 3 program will trigger a $25 million milestone payment from Astellas, according to the release.
Theravance is a South San Francisco, Calif., biopharmaceutical company focused on small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections and gastrointestinal motility dysfunction.
Astellas, based in Deerfield, Ill., is a U.S. affiliate of Tokyo-based Astellas Pharma Inc.
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