Cefepime/enmetazobactam meets criteria for superiority in Phase III trial

Allecra Therapeutics, a France-based biopharmaceutical company dedicated to the development of novel antibiotics, today revealed that the prestigious Journal of the American Medical Association (JAMA) has published the final results from its Phase III ALLIUM trial investigating the combination of cefepime/enmetazobactam in patients with complicated urinary tract infections (cUTIs).

According to the company, this represents the first full analysis of the completed Phase III program, which showed that cefepime/enmetazobactam met criteria for non-inferiority and superiority compared to piperacillin/tazobactam in the primary outcome of clinical cure and microbiological eradication.

Among patients with cUTI or acute pyelonephritis caused by gram-negative pathogens, cefepime/enmetazobactam, compared with piperacillin/tazobactam, met criteria for non-inferiority as well as superiority with respect to the primary outcome of clinical cure and microbiological eradication. The primary outcome occurred in 79.1% (273/345) of patients receiving cefepime/enmetazobactam compared to 58.9% (196/333) receiving piperacillin/tazobactam in the primary analysis data set (between group difference: 21.2% [95% CI, 14.3% to 27.9%]). In the 20.9% (142/678) of patients with an ESBL-producing baseline pathogen, 73.7% (56/76) of patients in the cefepime/enmetazobactam group and 51.5% (34/66) of those in the piperacillin/tazobactam group achieved the composite outcome (difference 30.2% [95% CI, 13.4% to 45.1%]).