Cubist制药公司正在开发的抗生素已进入Ⅲ期临床研究计划的第二阶段，该公司表示，这对它向FDA递交申请铺平了道路。

 Cubist披露，其ceftolozane/tazobactam（他唑巴坦）治疗复杂性腹腔内感染达到了主要终点指标，在启动治疗后26~30天临床治愈率不劣于标准治疗药美罗培南。副作用发生率与标准治疗药大致相同，最常见的不良反应为恶心、腹泻和发热。

 2013年12月，ceftolozane/tazobactam被证明对于复杂性尿路感染不劣于左氧氟沙星（levofloxacin）。Cubist 始终保持数据完整，该公司认为这是获得美国后欧盟批准所必须的。Cubist计划于2014年上半年提交两种适应症的新药申请。

Cubist Pharmaceuticals Inc : Cubist Updates on Positive Top-Line Results from Phase 3 Trial of Ceftolozane/Tazobactam in Intra-Abdominal Infections

Cubist Pharmaceuticals, Inc. announced positive top-line results from the Company's pivotal Phase 3 clinical trial of its antibiotic candidate ceftolozane/tazobactam in complicated intra-abdominal infections (cIAI).

According to a release, Ceftolozane/tazobactam, in combination with metronidazole, met the U.S. Food and Drug Administration (FDA) and theEuropean Medicines Agency (EMA) 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; the non-inferiority margin was 10 percent; and the lower and upper bounds of the 95 percent confidence interval were -8.9 percent and 0.5 percent, respectively. For the EMA, the primary analysis population was Clinically Evaluable (CE) patients; the non- inferiority margin was 12.5 percent; and the lower and upper bounds of the 99 percent confidence interval were -4.2 percent and 4.3 percent, respectively. Results of the secondary analysis were consistent with and supportive of the primary outcome.

The treatment emergent adverse event rate for ceftolozane/ tazobactam, in combination with metronidazole, was 44.0 percent and for meropenem was 42.7 percent. In this trial, the most commonly reported adverse events for ceftolozane/tazobactam in combination with metronidazole were nausea (7.9 percent), diarrhea (6.2 percent), fever (5.2 percent), insomnia (3.5 percent), and vomiting (3.3 percent). This adverse event profile is consistent with that seen with other cephalosporin antibiotics and comparable to meropenem in this trial.

In the cIAI trial, the spectrum of pathogens seen was typical with that seen in other pivotal trials in patients with these types of complicated infections. The most common Gram-negative pathogens observed in this trial included Escherichia coli (E. coli), Klebsiella pneumoniae (K. pneumoniae) and Pseudomonas aeruginosa (P. aeruginosa).

The cIAI trial results follow the positive data reported last month from a Phase 3 trial of ceftolozane/tazobactam compared to levofloxacin in patients with complicated urinary tract infections (cUTI).

"This is a significant and exciting milestone in our quest to provide new antibiotics to treat patients with serious and often life-threatening infections caused by drug-resistant bacteria," said  Steven Gilman , Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Cubist Pharmaceuticals. "With positive results from Phase 3 clinical trials of ceftolozane/ tazobactam in both cUTI and cIAI, we look forward to submitting these data to global regulatory authorities and presenting the full results at upcoming medical meetings."

According to  Philip S. Barie , M.D., M.B.A., Professor of Surgery and Public Health at Weill Cornell Medical College, attending surgeon at New York-Presbyterian Hospital/Weill Cornell Medical Center, and Executive Director of the Surgical Infection Society Foundation for Research and Education, "These data are encouraging as we face alarmingly increasing rates of bacterial resistance. There is an urgent need for new antibiotics, especially in the hospital setting, in order to be able to manage effectively those conditions complicated by serious infections, including those caused by resistant Gram-negative bacteria."

Based on the success of the 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. In the second half of 2014, the Company plans to submit a Marketing Authorization Application (MAA) to the EMA.

Additionally, ceftolozane/tazobactam is being developed for the potential treatment of Hospital-Acquired Bacterial Pneumonia (HABP)/ Ventilator-Associated Bacterial Pneumonia (VABP). The Company expects to initiate a pivotal Phase 3 trial to assess the safety and efficacy of ceftolozane/tazobactam in this indication during the first half of 2014.

Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address significant unmet medical needs in the acute care environment.

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