Venatorx Scores Victory over AMR in Phase III UTI Study
Venatorx Pharmaceuticals shared that its Phase III trial on the investigational treatment for complicated urinary tract infections in adults delivered positive outcomes.
Cefepime-taniborbactam is a combination of cefepime, a fourth-generation cephalosporin used against many gram-negative and gram-positive bacteria, and taniborbactam, a beta-lactamase inhibitor that works with the former to help treat severe bacterial infections. The duo is known for its ability to address infections caused by difficult-to-treat gram-negative bacteria that are typically resistant to drugs, such as Enterobacterales and Pseudomonas aeruginosa. Because of this resistance, treatments have been very limited.
Data from the U.S. Centers for Disease Control and Prevention show high resistance rates for many gram-negative bacteria, with more than 2.8 million infections reported annually. Antimicrobial resistance (AMR) is mostly seen in bacteremia, cUTI and acute pyelonephritis. The CDC projects that if this issue is not addressed promptly and no treatment is found, the number of AMR-related deaths could balloon to 10 million per year by 2050, even surpassing the 8.2 million deaths recorded under cancers.
In the Phase III CERTAIN-1 trial, researchers tested for the drug's safety, efficacy and tolerability in 661 adult participants who were divided into two groups, randomized 2:1. The first group received 2.5g of the medication every eight hours, while the other group received 1g of meropenem every eight hours for seven days. Participants with bacteremia had to take either drug for up to 14 days.
At the end of the tests, those given cefepime-taniborbactam demonstrated a 70% statistical noninferiority to meropenem, the trial's primary endpoint, compared to only 58% in those who took meropenem. The combination's superiority was sustained when the patients were re-evaluated on days 28 to 35.
"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. 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," said Christopher J. Burns, Ph.D., the president and chief executive officer of Venatorx, in a statement.
Venatorx is creating the drug alongside its exclusive global licensing partner Everest Medicines, which has the rights to develop and commercialize it in most Asian countries, including Mainland China, Macau, Singapore, Philippines, South Korea and Indonesia.
Cefepime-taniborbactam already has Fast Track and Qualified Infectious Disease Product designations from the U.S. Food and Drug Administration. It was developed from funds that the National Institute of Allergy and Infectious Disease, Department of Health and Human Services and the National Institutes of Health granted, as well as support from the Office of the Assistant Secretary for Preparedness and Response and the Biomedical Advanced Research and Development Authority.