Cubist Pharmaceuticals, Inc. (NASDAQ: CBST), a leading acute care therapeutics company, today announced that the recently-completed Phase 2 study of CXA-101, a novel cephalosporin, compared to ceftazidime for the treatment of complicated urinary tract infections (cUTI) in adults met its study objectives. 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 is a combination of CXA-101 and the beta-lactamase inhibitor tazobactam. Cubist acquired rights to CXA-101, and products which incorporate CXA-101, through its purchase of Calixa Therapeutics Inc. in December 2009.
“We are pleased with the results of this trial, which provide information that we intend to utilize in developing appropriate Phase 3 registration studies for CXA-201 in cUTI in consultation with the FDA.”
The study met its objectives of assessing safety and efficacy of CXA-101 in comparison to ceftazidime. CXA-101 additionally demonstrated favorable microbiological and clinical outcomes at the Test of Cure Visit, 6 - 9 days after end of therapy, which were the primary and secondary outcome measures in this study, respectively.
Cubist's Chief Medical Officer, Santosh Vetticaden, PhD, MD said, "We are pleased with the results of this trial, which provide information that we intend to utilize in developing appropriate Phase 3 registration studies for CXA-201 in cUTI in consultation with the FDA."
Steve Gilman, PhD, Cubist's Chief Scientific Officer, said, "We are pleased with the safety and microbiological response data from this study, which we believe supports the further development of CXA-201 as a useful therapeutic agent for the treatment of certain serious Gram-negative bacterial infections."
Cubist Pharmaceuticals, Inc.