Cubist Announces Positive Results From Ph 3 Trials Of Ceftolozane/Tazobactam

(RTTNews) - Cubist Pharmaceuticals, Inc. (CBST) on Friday announced the first detailed results from positive pivotal Phase 3 clinical trials of its antibiotic candidate ceftolozane/tazobactam in development to treat serious infections including complicated urinary tract infections and complicated intra-abdominal infections.

The new data include additional details on ceftolozane/tazobactam's clinical cure and/or microbiological eradication rates, which met or exceeded pre-specified U.S. Food and Drug Administration and European Medicines Agency non-inferiority margins, as well as details on the overall safety profile.

Additionally, for the first time Cubist is presenting data on microbiological eradication of key problematic Gram-negative pathogens, including Pseudomonas aeruginosa and extended-spectrum beta-lactamase-producing Escherichia coli and Klebsiella pneumoniae.

In the phase 3 clinical trial for complicated urinary tract infections, Ceftolozane/tazobactam met its primary endpoint of statistical non-inferiority compared to levofloxacin. The primary endpoint was a composite of microbiological eradication and clinical cure rate at 5 - 9 days after end of therapy.

In the phase 3 clinical trial for complicated intra-abdominal infections, Ceftolozane/tazobactam, in combination with metronidazole, met both the FDA and EMA 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.