Combination of candidate antibiotics shows promise for resistant UTIs
Venatorx Pharmaceuticals of Malvern, Pennsylvania, yesterday released promising data from a Phase 3 trial of its investigational new drug for patients with complicated urinary tract infections (cUTI).
The drug, cefepime-taniborbactam, combines a fourth-generation cephalosporin antibiotic with a beta-lactamase inhibitor and targets hard-to-treat drug-resistant gram-negative bacteria, including carbapenem-resistant Enterobacteriaceae and carbapenem-resistant Enterobacteriaceae. . Pseudomonas aeruginosa. It has received Qualified Infectious Disease Product and Fast Track designation from the United States Food and Drug Administration (FDA).
In the phase 3 randomized, double-blind study, which included 661 patients, researchers found that cefepime-taniborbactam met the primary efficacy endpoint of non-statistical inferiority to meropenem in patients with cUTI, including acute pyelonephritis.
In the microbiologic intention-to-treat test-of-cure (TOC) population, combined microbiologic and clinical success occurred in 70% of cefepime-taniborbactam-treated patients and 58% of meropenem-treated patients (treatment difference: 11.9 95% confidence interval [CI], 2.4 to 21.6). A pre-specified superiority test demonstrated the statistical superiority of cefepime-taniborbactam for the composite TOC endpoint.
Treatment-emergent adverse event rates were 35.5% for cefepime-taniborbactam and 29.9% for meropenem, with serious events occurring in 2% and 1.8% of patients, respectively.
“These data demonstrate that cefepime-taniborbactam may represent a significant improvement over the standard of care and could support global healthcare efforts to combat antibiotic-resistant infections,” said Venatorx President and CEO. , Christopher Burns, PhD, in a company press release. “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 developed cefepime-taniborbactam with funding from the National Institutes of Health, Department of Health and Human Services, Biomedical Advanced Research and Development Authority, and Wellcome Trust. In 2020, the company announced an agreement with the Global Antibiotic Research and Development Partnership to accelerate development and access to the drug for adult and pediatric populations.
The company said it plans to submit a new drug application to the FDA later this year.
March 10 Press release
Rise in sales of fluoroquinolone for food animals linked to resistance Salmonella
A review of fluoroquinolone sales data for food-producing animals and retail meat sample isolates found a link between increased fluoroquinolone sales and increased quinolone resistance in Salmonellatoday reported researchers in the Journal of Global Antimicrobial Resistance.
In the study, researchers from Penn State and the Pennsylvania Department of Health analyzed FDA data on antimicrobial sales for food-producing animals from 2013 to 2018 and examined susceptibility data to antibiotics from 4,138 non-typhoid animals. Salmonella (NTS) from retail samples of chicken, ground turkey, ground beef and pork chops. Samples were collected from 2009 to 2018 through the FDA’s National Antimicrobial Resistance Surveillance System. The investigators used the Pearson correlation to examine the association.
After adjusting for increased beef and pork production, the researchers found that sales of fluoroquinolones increased by 41.67% from 2013 to 2018, from 0.72 kilograms (kg) per kg meat production in 2013 to 1.02 in 2018. The prevalence of quinolone resistance The NTS of beef and pork samples increased from 0.62% in 2009 to 12.75% in 2018. The increase in quinolone resistant isolates in retail meats since 2016 was primarily linked to Salmonella Infants and Salmonella Enteritidis.
The correlation between the annual percentage of quinolone resistant NTS from beef and pork samples with the adjusted annual sales of fluoroquinolones was 0.67 (n = 6, P = 0.1449).
NTS is a major cause of foodborne illness worldwide, and although most NTS infections are self-limiting, approximately 5% of those infected develop invasive infections, for which the quinolone antibiotic ciprofloxacin is a treatment. of first intention. Antibiotic-resistant TNS are associated with excess bloodstream infections, longer hospital stays, higher healthcare costs, and increased mortality.
“Our results indicate a moderately positive correlation of annual sales of standardized fluoroquinolones with the annual prevalence of quinolone-resistant NTS in retail meats,” the study authors write. “The results of our study underscore the need for integrated surveillance to monitor antimicrobial resistance trends and detect the emergence of clinically relevant pathogens in humans and food animals.”
March 11 J Glob Antimicrobial Resist study