Superiority of cefepime-enmetazobactam demonstrated in subgroups of patients with extended spectrum β-lactamase (ESBL)-producing baseline uropathogens.
SAINT-LOUIS, France and WEIL AM RHEIN, Germany, October 23, 2020 – Allecra Therapeutics today announced that summary data from the Phase 3 (ALLIUM) trial evaluating cefepime-enmetazobactam (FPE) compared to the first-line standard of care, piperacillin-tazobactam (PTZ), in complicated urinary tract infections (cUTI) are being presented at this week’s IDWeek 2020.
The late-breaker oral presentation, “Cefepime-Enmetazobactam Demonstrates Superiority to Piperacillin-Tazobactam in a Subgroup of Patients with Complicated Urinary Tract Infections/Acute Pyelonephritis Caused by Extended Spectrum β-Lactamase-Producing Enterobacterales,” is being given by Keith Kaye, M.D., MPH. Dr. Kaye’s live talk will be held:
Session Title: Late Breaking Abstracts
Session Date: Saturday, October 24, 2020
Presentation Time: 10:20-10:30 AM EDT
Channel: 1
The replay will be available following the live event to all registrants. Click here for the abstract.
Keith Kaye M.D., MPH, Professor of Medicine and Director of Research for Infectious Diseases at University of Michigan, said, “ESBL-producing bacteria represent a growing threat around the globe and have led to increased carbapenem use and carbapenem resistance. These issues have created an urgent need for novel, therapeutic options for ESBL-producers.” Explaining the potential significance of this new data from the ALLIUM Phase 3 study, Dr. Kaye commented: “The data presented today demonstrate that cefepime-enmetazobactam was superior to standard of care treatment and support the potential of cefepime-enmetazobactam as a first-line treatment in settings where ESBL-producers are prevalent. Importantly, cefepime-enmetazobactam represents a legitimate therapeutic alternative to carbapenems for the treatment of ESBL-producing bacteria.”
As previously announced, the trial demonstrated superiority in its primary endpoint, with FPE showing a significant improvement over PTZ in the composite success outcome of clinical cure and microbiological eradication at the test-of-cure visit1. The new data are from subgroup analyses of patients with ESBL-producing bacteria – those resistant to either FPE or PTZ and those not resistant to either treatment. In both analyses1, FPE demonstrated superiority over PTZ.
In the trial, FPE was well tolerated, with 4.3% of patients reporting serious adverse events vs. 3.7 % with PTZ (0.2% vs. 0.6% assessed as drug related), suggesting a comparable safety profile to PTZ.