Shionogi & Co., Ltd. (hereafter "Shionogi") announced today that The Lancet Infectious Diseases journal has published clinical results from the pivotal randomized controlled trial evaluating cefiderocol for the treatment of complicated urinary tract infection (cUTI) in patients at risk of multidrug-resistant Gram-negative infections.
The paper is titled "Cefiderocol versus imipenem-cilastatin for the treatment of complicated urinary tract infections caused by Gram-negative pathogens: a phase 2, randomized, double-blind, non-inferiority trial."
Results from the study demonstrated treatment with cefiderocol met non-inferiority versus imipenem/cilastatin (IPM/CS) in patients with cUTI at test of cure (TOC). In the study, 73 percent (183/252) of patients in the cefiderocol group met the primary endpoint (combination of clinical response and microbiological response at TOC) versus 55 percent (65/119) in the IPM/CS group, with an adjusted treatment difference of 18.58 percent. These results in a post-hoc analysis showed that cefiderocol was superior to IPM/CS. The study enrolled 452 patients with cUTI and patients were randomly assigned 2:1 to cefiderocol and IPM/CS with a median duration of treatment of nine days for both groups.
The microbiologic response rate at TOC for the cefiderocol group was 73 percent (184/252) versus 56 percent (67/119) in the IPM/CS group, with the difference between groups at TOC at 17.25 percent. Although the study was designed to determine non-inferiority, the findings showed that cefiderocol resulted in a clinically meaningful microbiological eradication rates and outperformed IPM/CS. Additionally, cefiderocol exhibited a safety profile consistent with that of other cephalosporins.
"The data presented in The Lancet Infectious Diseases shows the potential of cefiderocol, particularly in a complicated patient population with comorbidities and at greater risk of multidrug-resistant infection with difficult to treat Gram-negative bacteria," said Dr. Tsutae "Den" Nagata, Chief Medical Officer, Shionogi & Co. Ltd. "Once approved, cefiderocol will be an important, new antibiotic option for providers caring for these very sick patients who may have very limited treatment options."