Shionogi has announced positive results from the APEKs-cUTI* study which evaluated their novel antibiotic, cefiderocol (S-649266), for the treatment of patients with serious complicated urinary tract infection (cUTI) by Gram-negative bacteria.
APEKs-cUTI* was an international, multicenter, double-blind, randomized, non-inferiority trial evaluating the efficacy, safety, and tolerability of cefiderocol vs imipenem/cilastatin (IPM/CS) in 452 hospitalized adult patients with cUTI, with or without pyelonephritis, at test of cure (TOC), defined as approximately 7 days after end of treatment. Patients received either cefiderocol 2g IV every 8 hours or IPM/CS 1g IV every 8 hours for 7 to 14 days. Complicated patients, including the immunocompromised and renal transplants, were included in the study.
Results showed that cefiderocol met the FDA pre-specified primary endpoint for non-inferiority, demonstrating superiority to IPM/CS at TOC in patients with serious Gram-negative cUTI. The composite of clinical cure and microbiologic eradication at TOC was met in 72.6% of cefiderocol-treated patients, compared to 54.6% in the IPM/CS arm, a weighted difference of 18.58% (95% CI, 8.23 – 28.92). Data also showed that cefiderocol was well tolerated, with fewer patients experiencing adverse events compared to IPM/CS, 40% vs 50%, respectively. Detailed results from the APEKs-cUTI* study are anticipated for presentation in early 2017.
The FDA previously granted cefiderocol Qualified Infectious Disease Product (QIDP) designation which allows for priority review and provides eligibility for fast-track approval status. Shionogi intends to submit a New Drug Application (NDA) for cefiderocol to the FDA this year.
Cefiderocol is a novel siderophore cephalosporin with a more efficient mechanism of action. It penetrates the outer cell membrane of Gram-negative pathogens by binding to ferric iron, which becomes actively transported into the cells via the bacterial iron transporters, allowing for higher concentrations in the periplasmic space.
Shionogi announces positive top-line results for cefiderocol pivotal cUTI clinical trial [news release]. Osaka, Japan and Florham Park, NJ: Shionogi Inc. Published January 12, 2017. Accessed January 13, 2017.
This article originally appeared on MPR