LEXINGTON, Mass.--(BUSINESS WIRE)-- Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced the initiation of a pivotal Phase 3 trial of CXA-201 (ceftolozane/tazobactam) in patients with complicated intra-abdominal infections (cIAI). CXA-201 is being developed as a first-line intravenous therapy for the treatment of serious Gram-negative bacterial infections in the hospital, including those caused by multi-drug resistant Pseudomonas aeruginosa. Earlier this year Cubist initiated two Phase 3 trials of CXA-201 in patients with complicated urinary tract infections.
This trial is the first of two multicenter, global, double-blind, randomized Phase 3 studies to compare the safety and efficacy of CXA-201 (in combination with metronidazole) relative to the comparator, meropenem, in patients with cIAI. The primary objective of the study is to establish non-inferiority of CXA-201 to the comparator with respect to the proportion of patients who achieve clinical cure 26-30 days after initiation of the study drug. Cubist expects to enroll approximately 780 patients in this trial, which will also assess the safety of CXA-201 and investigate other pre-specified secondary endpoints.
Cubist’s Chief Medical Officer Santosh Vetticaden, PhD, MD, said, “We are extremely pleased that we have been able to rapidly advance the development of CXA-201 and that within the space of a few months we are now concurrently engaged in four pivotal Phase 3 trials with CXA-201 for 2 separate indications. There is a dire need for antibiotics for serious infections and in particular for infections caused by Gram-negative bacteria. CXA-201, assuming approval by regulatory authorities, will provide clinicians with an important new therapeutic option in the battle against Gram-negative bacteria, especially Pseudomonas aeruginosa.”
About Gram-negative bacteria
The diseases caused by Gram-negative bacteria include peritonitis, septicemia, pneumonia, neonatal meningitis, urinary tract infections, intra-abdominal infections, and burn and wound infections. In the US in 2003, Gram-negative bacteria were associated with many of the most frequent types of hospital-acquired infections including 71% of urinary tract infections, 65% of pneumonia episodes, 34% of surgical site infections, and 24% of bloodstream infections. Important Gram-negative bacteria include P. aeruginosa, Escherichia coli, Klebsiella pneumoniae, and Acinetobacter baumannii.
About Pseudomonas aeruginosa
Recent medical literature identifies P. aeruginosa as one of the most prevalent Gram-negative pathogens responsible for hospital-acquired infections, and points to its significant virulence and steeply increasing incidences in intensive care units (ICUs). Data from the National Nosocomial Infections Surveillance of ICUs in the United States identified P. aeruginosa as the most frequently isolated Gram-negative strain, with an incidence almost doubling between 1975 and 2003. For example, an increase of P. aeruginosa from 9.6% to 16.3% was shown in nosocomial pneumonia and from 9.3% to 16.3% in urinary tract infections. Similar increases in P. aeruginosa-related infections were shown by the SENTRY Antimicrobial Surveillance Program for Europe, comparing data between 1997 and 2002. Pseudomonal infections can involve any part of the human body, but among the most common are urinary tract, lung, bloodstream, wound/burn, and intra-abdominal infections. Resistance to current treatment regimens for such infections is growing, with the increasing appearance of P. aeruginosa strains expressing multi-drug resistance against the commonly used first-line anti-pseudomonal antibiotics.
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. Cubist is headquartered in Lexington, Mass. Additional information can be found at Cubist’s web site at www.cubist.com.
Cubist Safe Harbor Statement
This press release contains forward-looking statements regarding the clinical development of CXA-201, including plans to run Phase 3 clinical trials for this compound in cUTI and cIAI and the therapeutic potential of CXA-201. There are many factors that could cause actual results to differ materially from those in these forward-looking statements. These factors include the following: CXA-201 may not show sufficient therapeutic effect or an acceptable safety profile in Phase 3 clinical trials; CXA-201 may not act in the way expected based on prior clinical and pre-clinical trials; clinical trials of CXA-201 may not be successful or initiated or conducted in a timely manner and the timing of initiation and conduct of subsequent trials is dependent on our ability to successfully work with regulatory authorities, including the FDA on the design of the trials, among other things; we plan to rely, to a significant extent, on third party clinical research organizations, or CROs, to help us conduct clinical trials so the success and timing of the trials is dependent our ability to work with such CROs and their performance; the commercial market for the intended use of CXA-201 may not be as large as Cubist anticipates; if approved, CXA-201 will compete with products currently on the market and may also compete with products currently in development which may have superior efficacy and/or safety profiles as CXA-201 or have other attributes that make it difficult for CXA-201 to succeed commercially in such markets; technical difficulties or excessive costs relating to the manufacture or supply of CXA-201; we plan to rely, to a significant extent, on third party contract manufacturers and suppliers to manufacture and supply CXA-201 on our behalf so our ability to obtain adequate supplies of CXA-201 is dependent on our ability to work with such third parties and on their performance; we, and Astellas Pharma Inc., from which we have licensed the rights underlying CXA-201 and which has an interest in the intellectual property protecting CXA-201, may not be able to maintain and enforce such intellectual property; and we may encounter other unanticipated or unexpected risks with respect to the development or manufacture of CXA-201. Drug development involves a high degree of risk. Success in pre-clinical trials or early stage clinical trials does not mean that later stage trials will be successful. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in Cubist's recent periodic filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in such filings. These statements speak only as of the date of this release, and Cubist undertakes no obligation to update or revise these statements, except as may be required by law.
Cubist Pharmaceuticals, Inc.
Eileen C. McIntyre, 781-860-8533
Senior Director, Investor Relations
Cubist Pharmaceuticals, Inc.
Francis McLoughlin, 781-860-8777
Director, Corporate Communications
KEYWORDS: United States North America Massachusetts
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Hospitals Infectious Diseases Pharmaceutical Research Science