Strong Ph III data on Cubist's Cubicin

The USA's Cubist Pharmaceuticals has welcomed data published in the August 17 issue of the New England Journal of Medicine from a landmark Phase III study of its drug candidate Cubicin (daptomycin for injection) as monotherapy versus dual therapy standard-of-care for the treatment of patients with Staphylococcus aureus blood stream infections and infective endocarditis (infection of the heart valves).

According to Cubist, the study results show that 6mg/kg of the agent intravenously administered once-daily was as effective as standard-of-care comparator for the treatment of S aureus bacteremia including right-sided endocarditis. The US Food and Drug Administration approved a supplemental New Drug Application to expand the indication for Cubucin 6mg/kg once daily for this indication. The firm noted that Cubicin is now the only therapy approved for treatment of S aureus blood stream infections based on a prospective registration trial.

The study met the pre-specified criteria for the non-inferiority of Cubicin relative to standard-of-care therapy. In the intent to treat analysis, success rates at test of cure were 44.2% of 120 Cubicin-treated patients vs 41.7% of 115 comparator-treated patients. Success rates were similar in the patients with complicated bacteremia, and in patients with right-sided endocarditis, Cubist noted.