Theravance Announces Results From FAST 2 -- Phase 2 Clinical Study With Investigational Antibiotic Telavancin

SOUTH SAN FRANCISCO, Calif. -- Theravance, Inc. announced results from FAST 2, a Phase 2 clinical study with the investigational antibiotic telavancin (TD-6424).

FAST 2 was a randomized, double-blind, multinational study of intravenous telavancin dosed once a day or standard therapy (vancomycin dosed twice a day or antistaphylococcal penicillins dosed four times a day) for the treatment of complicated Gram-positive skin and skin structure infections (cSSSI).  Two hundred and one patients at 18 clinical sites in the United States and South Africa were randomized to receive either standard therapy or 10 mg/kg telavancin.  The clinical cure rates in the clinically evaluable population were 96.1 percent and 93.5 percent for patients treated with telavancin and standard therapy, respectively.  Notably, in the group of microbiologically evaluable patients with methicillin-resistant Staphylococcus aureus (MRSA) infection, eradication was achieved in 92.3 percent of the telavancin-treated group versus 68.4 percent in the group receiving vancomycin (p=0.043). The overall incidence and severity of adverse events were similar in the telavancin-treated and standard therapy groups.

Michael Kitt, MD, senior vice president of development for Theravance noted, The safety and tolerability results from FAST 2 are consistent with those obtained in our first Phase 2 study (FAST), where telavancin was dosed at 7.5 mg/kg.  Together with the in vitro and experimental infection model data generated for telavancin, the clinical success, microbiological eradication and safety results are very encouraging and support the planned and ongoing Phase 3 program.  Studies in this program are designed to demonstrate non-inferiority of telavancin compared to vancomycin for the treatment of serious gram-positive infections and superiority over vancomycin in those patients whose infections are due to MRSA in both cSSSI and hospital-acquired pneumonia.

Telavancin, a rapidly bactericidal injectable antibiotic, is a novel lipoglycopeptide that was discovered by Theravance through the application of multivalent drug design.  Previously presented data demonstrated that telavancin has a unique multiple mechanism of action that the company believes speeds bacterial killing and reduces the risks of inducing resistance.  This antibacterial activity results from interaction with D-Ala-D-Ala-containing peptidoglycan intermediates that leads, at submicromolar concentrations, to inhibition of the transglycosylation step of peptidoglycan synthesis during cell wall synthesis.  Also, at higher, clinically-achievable concentrations, direct effects on bacterial plasma membrane function, such as membrane potential depolarization and increased permeability, are observed.  Telavancin is currently in Phase 3 studies for the treatment of complicated skin and skin structure infections.

Source: Theravance, Inc.