Cubist Announces Positive Phase 3 Trial Results for Ceftolozane/Tazobactam in Intra-Abdominal Infections

Cubist Pharmaceuticals

today announced positive top-line results from the Company's pivotal Phase 3 clinical trial of its antibiotic candidate ceftolozane/tazobactam in complicated intra-abdominal infections (cIAI). Ceftolozane/tazobactam, in combination with metronidazole, met the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) defined primary endpoints of statistical non-inferiority compared to meropenem. The primary endpoint was a clinical cure rate 26 - 30 days after the initiation of therapy (the Test of Cure visit). For the FDA, the primary analysis was conducted in the Microbiological Intent-to-Treat (MITT) population; the non-inferiority margin was 10%; and the lower and upper bounds of the 95% confidence interval were -8.9% and 0.5%, respectively.