Cubist Achieves Positive Phase III Ceftolozane Results

Cubist Pharmaceuticals achieved positive top-line results from a Phase III 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. The primary endpoint was microbiological eradication and clinical cure rate at 5 – 9 days after the end of therapy. The 95% confidence interval around the treatment difference had lower and upper bounds of 2.3% and 14.6%, respectively, favoring ceftolozane/tazobactam.

The treatment emergent adverse event rate for ceftolozane/tazobactam was 34.7% and for levofloxacin was 34.4%. The most commonly reported adverse events headache (5.8%), constipation (3.9%), hypertension (3%), nausea (2.8%), and diarrhea (1.9%).