Cubist Announces Positive Top-Line Results from Phase 3 Trial of Investigational Antibiotic Ceftolozane/Tazobactam in Complicated Urinary Tract Infections

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced positive top-line results from the Company’s pivotal Phase 3 clinical trial of its antibiotic candidate ceftolozane/tazobactam in complicated urinary tract infections (cUTI). Ceftolozane/tazobactam met its primary endpoint of statistical non-inferiority compared to levofloxacin (10% non-inferiority margin). The primary endpoint is a composite of microbiological eradication and clinical cure rate (composite cure rate) at 5 - 9 days after end of therapy (the Test of Cure visit). The 95% confidence interval around the treatment difference had lower and upper bounds of 2.3% and 14.6%, respectively, favoring ceftolozane/tazobactam. Results of the secondary analyses were consistent with and supportive of the primary outcome. [ABSTRACT FROM PUBLISHER]