Cubist announced positive top-line results from its pivotal Phase 3 clinical trial of its antibiotic candidate ceftolozane/tazobactam in complicated intra-abdominal infections (cIAI). Ceftolozane/tazobactam is an antibiotic candidate being developed to treat certain Gram-negative infections. Ceftolozane is a cephalosporin antibiotic; tazobactam is a β-lactamase inhibitor.
Ceftolozane/tazobactam, in combination with metronidazole, met the FDA 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. Results demonstrated a non-inferiority margin of 10% and the lower and upper bounds of the 95% confidence interval were -8.9% and 0.5%, respectively.
Additionally, ceftolozane/tazobactam is being developed for the potential treatment of Hospital-Acquired Bacterial Pneumonia (HABP)/Ventilator-Associated Bacterial Pneumonia (VABP). Cubist expects to initiate a Phase 3 trial to assess the safety and efficacy of ceftolozane/tazobactam in this indication during the first half of 2014.
Ceftolozane/tazobactam has been granted Fast Track status, by the FDA for its respective Qualified Infectious Disease Product (QIDP) indications. Based on the success of the complicated urinary tract infections (cUTI) and cIAI trials, Cubist expects to submit a New Drug Application (NDA) to the FDA in the first half of 2014 for approval in both of these indications.
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