Positive results for cefiderocol in cUTI clinical trial

Japanese drugmaker Shionogi (TYO: 4507) has announced positive top-line trial results for cefiderocol (S-649266), a novel siderophore cephalosporin in late-stage development,

The drug met the US Food and Drug Administration pre-specified primary endpoint for non-inferiority versus imipenem/cilastatin (IPM/CS) in patients with serious complicated urinary tract infection (cUTI) with Gram-negative bacteria. Cefiderocol was superior to IPM/CS at test of cure (TOC), the company noted.

The study APEKs-cUTI enrolled 452 patients with cUTI. The median duration of treatment was nine days for both cefiderocol and IPM/CS for all populations. Cefiderocol met the FDA primary efficacy endpoint of composite of clinical cure and microbiologic eradication at test of cure (TOC) in 72.6% of patients (n=252) which was superior to IPM/CS at 54.6% (n=119), a weighted difference of 18.58% (95% CI: 8.23, 28.92).