Positive results were announced from a phase 3 study evaluating cefepime-taniborbactam for the treatment of adults with complicated urinary tract infections (cUTI), including acute pyelonephritis.

The investigational drug is a combination of cefepime, a cephalosporin antibiotic, and taniborbactam, a novel beta-lactamase inhibitor. The Company believes that the combination may provide another therapeutic option for difficult-to-treat drug resistant gram-negative bacteria, such as carbapenem-resistant Enterobacterales and carbapenem-resistant Pseudomonas aeruginosa.

The global, randomized, double-blind, active-controlled CERTAIN-1 study (ClinicalTrials.gov Identifier: NCT03840148) compared the efficacy and safety of cefepime-taniborbactam to meropenem in 661 adults with cUTI, including acute pyelonephritis. Patients were randomly assigned 2:1 to receive cefepime-taniborbactam 2.5 mg intravenously (IV) every 8 hours or meropenem 1 g IV every 8 hours for 7 days (up to 14 days for patients with bacteremia). 


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The primary endpoint was the composite of microbiological eradication and symptomatic clinical success at the test of cure (TOC) visit (days 19-23) in the microbiological intent-to-treat (microITT) population.

Results showed that treatment with cefepime-taniborbactam met the primary endpoint achieving statistical noninferiority to meropenem at the TOC visit in the microITT population. Composite microbiologic and clinical success occurred in 70% of patients treated with cefepime-taniborbactam compared with 58% of patients treated with meropenem (treatment difference 11.9%; 95% CI, 2.4-21.6). Moreover, cefepime-taniborbactam demonstrated statistical superiority to meropenem for the composite endpoint at TOC, which was sustained at the Late-Follow-Up visit (days 28-35).

Treatment-emergent adverse events (TEAEs) occurred in 35.5% of patients treated with cefepime-taniborbactam and 29% of patients treated with meropenem. Serious TEAEs occurred in 2% of patients treated with cefepime-taniborbactam and 1.8% of patients treated with meropenem.

Complete study results will be presented at an upcoming scientific meeting. The Company plans to submit a New Drug Application to the Food and Drug Administration (FDA) later this year.

“These data demonstrate that cefepime-taniborbactam may represent a significant improvement over the standard of care and could support global health efforts to combat antibiotic-resistant infections,” said Christopher J. Burns, PhD, President and CEO of Venatorx. “Cefepime-taniborbactam, if approved by the FDA, may offer a new treatment option for patients with infections caused by highly resistant bacteria, even those resistant to widely used carbapenem antibiotics.” 

Reference

Venatorx Pharmaceuticals announces positive results for phase 3 clinical trial (CERTAIN-1) of cefepime-taniborbactam for treatment of cUTI. News release. Venatorx Pharmaceuticals. Accessed March 10, 2022. https://www.businesswire.com/news/home/20220310005341/en/Venatorx-Pharmaceuticals-Announces-Positive-Results-for-Phase-3-Clinical-Trial-CERTAIN-1-of-Cefepime-Taniborbactam-for-Treatment-of-cUTI

This article originally appeared on MPR