Cubist Pharmaceuticals, Inc. is a pharmaceutical company that hit bottom recently, looking for a big leg up now. 10Q was released on 05/02/2014.
65 HAYDEN AVENUE
LEXINGTON MA 02421
65 HAYDEN AVENUE
LEXINGTON MA 02421
Cubist Pharma presents detailed results from positive Phase 3 trials of Ceftolozane/Tazobactam
Co announces 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.
Phase 3 clinical trial in cUTI
Ceftolozane/tazobactam met its primary endpoint of statistical non-inferiority compared to levofloxacin (10% non-inferiority margin). The primary endpoint was a composite of microbiological eradication and clinical cure rate (composite cure rate) at 5 - 9 days after end of therapy-the Test of Cure (TOC) visit. The composite cure rates at TOC in the Microbiological Modified Intent-to-Treat (mMITT) and Per Protocol (PP) populations were 76.9% versus (vs.) 68.4% and 83.3% vs. 75.4%, respectively. Although this trial was not prospectively designed to demonstrate superiority, the finding that the lower bound of the confidence interval around the positive treatment differences in favor of ceftolozane/tazobactam was greater than zero, indicated statistical superiority over levofloxacin in this trial. Results of the secondary analyses were consistent with and supportive of the primary outcome. Microbiological eradication rates for ceftolozane/tazobactam vs. levofloxacin were 80.4% vs. 72.1% in the mMITT population and 86.2% vs. 77.6% in the PP population. Clinical trial data showed the following per-pathogen microbiological eradication rates in the Microbiologically Evaluable (ME) population for ceftolozane/tazobactam vs. levofloxacin:
Phase 3 clinical trial in cIAI
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-the TOC visit. For the FDA, the primary analysis was conducted in the Modified Intent-to-Treat (MITT) population where the overall clinical cure rate was 83.0% for ceftolozane/tazobactam in combination with metronidazole vs. 87.3% for meropenem. For the FDA, statistical non-inferiority was defined at a pre-specified 10% non-inferiority margin. For the EMA, the primary analysis was conducted in the Clinically Evaluable (CE) population where the overall clinical cure rate was 94.1% for ceftolozane/tazobactam in combination with metronidazole vs. 94.0% for meropenem. For the EMA, statistical non-inferiority was defined at a pre-specified 12.5% non-inferiority margin. Results of the secondary analyses were consistent with and supportive of the primary outcome. Per-pathogen microbiological eradication rates for ceftolozane/tazobactam vs. meropenem were comparable between groups. Clinical cure in patients infected with ESBL-producing Enterobacteriaceae was achieved in 86.2% and 82.8% of patients in the ceftolozane/tazobactam in combination with metronidazole and meropenem treatment groups, respectively. Clinical trial data showed the following per-pathogen microbiological eradication rates in Gram-negative aerobes in the ME population for ceftolozane/tazobactam in combination with metronidazole vs. meropenem: E. coli (n=426): 96% vs. 95% Klebsiella pneumoniae (n=53): 100% vs. 88% Pseudomonas aeruginosa (n=53): 100% vs. 100% The most commonly reported adverse events for ceftolozane/tazobactam in combination with metronidazole were nausea (7.9%), diarrhea (6.2%), and fever (5.2%). In this trial, other adverse events for ceftolozane/tazobactam included insomnia (3.5%) and vomiting (3.3%). This adverse event profile is consistent with that seen with other cephalosporin antibiotics and comparable to meropenem in this trial.