Cubist reports positive Phase III trial of novel antibiotic

Cubist Pharmaceuticals has presented positive results from the firstPhase III trial of its novel intravenous antibiotic Cidecin (daptomycin) in the treatment of complicated skin and soft tissue infections caused by Gram-positive bacteria, revealing that the new agent was as effective as standard-of-care antibiotics in this indication, requiring fewer days of treatment and with a comparable side-effect profile.

Cidecin met its primary endpoint in the 562-patient international study, namely equivalence to comparator agents (either vancomycin or oxacillin) in the management of the clinical signs and symptoms of Gram-positive infections, with results that were within 1% of those achieved by the standard-of-care drugs. The US Food and Drug Administration will usually consider a drug equivalent if it can achieve scores within 10% of comparator agents.

Clinical success rates for Cidecin ranged from 81%-91% in all patient populations compared to a range of 81%-92% in the comparator arm. Adverse events were also comparable in the two groups, with creatinine phosphokinase levels and other toxicity indicators essentially the same. Additionally, patients receiving Cidecin required a shorter duration of therapy than those in the comparator arm, with 79% of patients achieving a clinically successful outcome within four to seven days, compared to 40% of the comparator group.