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 2.5mg intravenously (IV) every 8 hours or meropenem 1g IV every 8 hours for 7 days (up to 14 days for patients with bacteremia).
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.”
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