Positive Phase 3 Results for Cefepime-Taniborbactam in Treating Complicated UTIs Published in NEJM

A recent publication in The New England Journal of Medicine highlighted the effectiveness of cefepime-taniborbactam, a new antibiotic, in treating complicated urinary tract infections (cUTI) and acute pyelonephritis (AP) in adults. The study, known as CERTAIN-1, involved a comparison between cefepime-taniborbactam and the widely used meropenem.

The research indicated that cefepime-taniborbactam outperformed meropenem in terms of composite efficacy, which is a measure of both microbiological and clinical response. The drug demonstrated a response rate of 70.6% compared to meropenem's 58.0%. Furthermore, the superiority of cefepime-taniborbactam was statistically significant, with a 12.6% higher response rate at the Test of Cure visit.

Cefepime-taniborbactam is a combination of cefepime, a fourth-generation cephalosporin, and taniborbactam, a novel beta-lactamase inhibitor. This combination provides broad coverage against various types of bacteria, including those that are resistant to multiple classes of antibiotics. The drug has shown promise in treating infections caused by Enterobacterales and Pseudomonas aeruginosa, which are common in cUTI cases.

The safety profile of cefepime-taniborbactam was found to be on par with meropenem, with treatment-emergent adverse events occurring in 35.5% of patients treated with cefepime-taniborbactam and 29.0% of those treated with meropenem. Serious adverse events were rare, occurring in only 2.0% of patients on cefepime-taniborbactam and 1.8% on meropenem.

The CERTAIN-1 study was a randomized, multicenter, double-blind, active-controlled, non-inferiority trial involving 661 hospitalized patients. The primary endpoint was the composite microbiologic and clinical response at the Test of Cure visit. The study concluded that cefepime-taniborbactam not only met the non-inferiority margin but also showed superiority over meropenem.

The results of the CERTAIN-1 study are significant as they offer a new treatment option for patients with serious bacterial infections, particularly those caused by drug-resistant gram-negative pathogens. The findings are expected to contribute to the ongoing efforts to combat antibiotic resistance and provide more effective treatments for complicated urinary tract infections.

The development of cefepime-taniborbactam has been supported by various funding partners and collaborations, including the National Institute of Allergy and Infectious Diseases and the Wellcome Trust. The drug is currently under review by the FDA for the treatment of cUTI, and if approved, it could become an important addition to the arsenal against antibiotic-resistant infections.