Cubist commences enrollment in Phase 2 study of CXA-201 for complicated intra-abdominal infections

Jul 1 2010

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST), a leading acute care therapeutics company, today announced the enrollment of the first patient in a Phase 2 study with CXA-201. This multicenter, double-blind, randomized, study will compare the safety and efficacy of intravenous CXA-201 with an active comparator in patients with complicated intra-abdominal Infections (cIAI). This international study is expected to enroll 120 patients.

“Multi-drug resistant Gram-negative infections represent a very important unmet medical need. CXA-201 has broad spectrum activity against Gram-negative pathogens, including multi-drug resistant Pseudomonas aeruginosa as well as most strains of ESBL-producing Enterobacteriaceae, which are serious pathogens for which limited therapeutic alternatives exist.”

Cubist acquired rights to develop and commercialize CXA-201 worldwide except in select Asia-Pacific and Middle East territories through Cubist's purchase of Calixa Therapeutics Inc. in December 2009. CXA-201 is the combination of a novel cephalosporin (CXA-101) with the beta-lactamase inhibitor tazobactam. Cubist is developing CXA-201 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. CXA-201 has demonstrated potency against P. aeruginosa in in vitro studies, and the company believes that this is predictive of a highly differentiated profile versus marketed antibiotics.

Cubist's Chief Medical Officer, Santosh Vetticaden, PhD, MD, said, "This clinical milestone represents an important advance in the development of CXA-201 and for our pipeline as we continue to build a portfolio of potential new therapies for acutely ill patients."

Steve Gilman, PhD, Cubist's Chief Scientific Officer said, "Multi-drug resistant Gram-negative infections represent a very important unmet medical need. CXA-201 has broad spectrum activity against Gram-negative pathogens, including multi-drug resistant Pseudomonas aeruginosa as well as most strains of ESBL-producing Enterobacteriaceae, which are serious pathogens for which limited therapeutic alternatives exist."