Acute care therapeutics company, Cubist Pharmaceuticals' phase-2 safety study of Cubicin (daptomycin for injection) in the treatment of prosthetic joint infections caused by certain Gram positive pathogens met its study objectives. This study was a first-of-its-kind randomized controlled phase-2 trial studying anti-infective therapy in the setting of two-stage surgery for the replacement of infected prosthetic hip or knee joints.
The study compared Cubicin at doses of 6 and 8 mg/kg with standard of care (vancomycin, teicoplanin or semi-synthetic penicillins) administered for approximately six weeks following surgery to remove the infected prosthesis. The primary objective was to assess the safety and tolerability of Cubicin at the two doses studied. The number of adverse events for both dosing regimens was similar to comparator therapy. Although primarily a safety study, clinical and microbiological outcomes were assessed following treatment-with a Test of Cure (TOC) visit 1-2 weeks following the second surgery where a new prosthetic joint was placed. The clinical response rate for CUBICIN at both doses studied was numerically higher than comparator at the TOC visit. This study was not powered for statistical significance.
The company plans to submit these results as a late breaker to a fall 2010 infectious disease conference.
Cubicin (daptomycin for injection) is approved in the US and many other markets as therapy for Staphylococcus aureus bloodstream infections (bacteremia), including right-sided endocarditis caused by methicillin-resistant S. aureus (MRSA), and complicated skin infections caused by certain Gram-positive bacteria, including MRSA.
Cubist Pharma is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment.