Cubist said that CXA-201, a combined product of CXA-101 and the beta-lactamase inhibitor tazobactam, is being developed by the company 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.
Cubist got access to CXA-101 and products which incorporate CXA-101 by acquiring Calixa Therapeutics in December 2009.
Cubist claimed that CXA-201 Phase 2 study assessing safety and efficacy of the drug in comparison to ceftazidime has met its objectives. Additionally CXA-201 showed avorable microbiological and clinical outcomes at the Test of Cure Visit, 6 to 9 days after end of therapy, which were the primary and secondary outcome measures in this study, respectively.
Santosh Vetticaden, chief medical officer of Cubist, said: “We are pleased with the results of this trial, which provide information that we intend to utilise in developing appropriate Phase 3 registration studies for CXA-201 in cUTI in consultation with the FDA.”