Ceftolozane/tazobactam success in Phase III for UTI-Cubist

Cubist Pharmaceuticals, Inc. announced positive top-line results from the Company�s pivotal Phase III 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, favouring ceftolozane/tazobactam. Results of the secondary analyses were consistent with and supportive of the primary outcome. Although this trial was not prospectively designed to demonstrate superiority, the finding that the lower bound of the 95% confidence interval around the positive treatment differences in favour of ceftolozane/tazobactam was greater than zero indicated statistical superiority over levofloxacin in this trial.

A further pivotal trial for the combination compared to meropenem is ongoing in complicated intra abdomial infections (cIAU) and is expected to report in late December.