Daptomycin: Phase II data; Phase III

CBST reported combined results from 63 patients in two ongoing dose-ranging U.S. Phase II trials of daptomycin. Among those evaluable, 56 patients received either 4 mg/kg or 6 mg/kg once per day, or 3 mg/kg twice per day of daptomycin, and 7 patients received standard doses of either vancomycin, oxacillin or nafcillin. Daptomycin provided an overall clinical success rate of 91 percent, 63 percent, and 45 percent in the three dose groups, respectively, compared with 71 percent in the control arm. Daptomycin had a microbiologic eradication rate of 91 percent, 67 percent, and 55 percent at each of the three doses, compared with 71 percent in the control arm.

In patients resistant or contraindicated for vancomycin, the 4 mg/kg daptomycin dose had a clinical success rate of 86 percent. Adverse events were comparable to standard treatment, CBST said. Data were presented at the Nosocomial and Healthcare-Associated Infections conference in Atlanta. CBST is conducting Phase III trials with 4 mg/kg daptomycin in complicated skin and soft tissue infections. ...