Cubist Pharma: Ceftolozane/tazobactam Met Primary Endpoint In Phase 3 Trial

(RTTNews) - Cubist Pharmaceuticals, Inc. (CBST) Monday 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 or cUTI.

Ceftolozane/tazobactam met its primary endpoint of statistical non-inferiority compared to levofloxacin.

The primary endpoint is a composite of microbiological eradication and clinical cure rate at 5 - 9 days after end of therapy. The 95 percent confidence interval around the treatment difference had lower and upper bounds of 2.3 percent and 14.6 percent, respectively, favoring ceftolozane/tazobactam.

Results of the secondary analyses were consistent with and supportive of the primary outcome.

The spectrum of Gram-negative pathogens seen in the trial was typical of that seen in other clinical trials in patients with complicated urinary tract infections.

Cubist is concluding a pivotal Phase 3 trial of ceftolozane/tazobactam in patients with complicated intra-abdominal infections or cIAI.