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 7–14 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.
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