Cubist product meets in Phase III cIAI trials

Cubist Pharmaceuticals Inc. (NASDAQ:CBST) said IV ceftolozane/tazobactam every eight hours plus IV metronidazole for 4-14 days met the FDA-defined primary endpoint and the EMA-defined primary endpoint in pooled data from 993 patients in a pair of identical, double-blind Phase III trials to treat complicated intra-abdominal infections (cIAIs). The FDA-defined primary endpoint was non-inferiority to meropenem in the proportion of patients in the microbiological intent-to-treat (MITT) population who achieved clinical cure at the test-of-cure (TOC) visit. The EMA-defined primary endpoint was non-inferiority to meropenem in the proportion of patients in the clinically evaluable population who achieved clinical cure at the TOC visit .

Last month, Cubist reported that IV ceftolozane/tazobactam met the FDA- and EMA-defined primary endpoints of non-inferiority to IV levofloxacin in a pair of identical Phase III trials to treat complicated urinary tract infection (cUTI) (see BioCentury Extra, Nov. 25). ...