Cubist Completes Treatment Phase in Endocarditis/Bacteremia Study

Cubist Pharmaceuticals has announced that all of the enrolled patients in the Cubicin endocarditis/bacteremia study have completed the treatment phase of the trial, and the remaining patients are now in the follow-up period.

Data from 191 patients were reviewed at the independent data monitoring committee (DMC) meeting, completing the fifth planned safety review of patients enrolled in Cubist's ongoing international Phase III clinical trial examining the safety and efficacy of Cubicin (daptomycin for injection) in the treatment of infective endocarditis and complicated bacteremia caused by Staphylococcus aureus. As all patients have now completed treatment, no decision regarding the continuation of the study was required from the DMC.

Due to the high mortality rate associated with endocarditis, blinded clinical data from patients enrolled in the study are provided to the DMC at predetermined intervals to identify any safety-related issues. Patients with blood cultures positive for the presence of S. aureus were enrolled at sites in the U.S. and certain Western European countries. The study protocol includes patients with infective endocarditis and complicated or uncomplicated bacteremia. In the study, patients received either Cubicin, at 6 mg/kg once daily, or the current standards of care, vancomycin in patients with confirmed methicillin-resistant S. aureus infection or a semisynthetic penicillin if susceptible S. aureus is confirmed. Cubist continues to expect to report results from this trial in mid-2005.