Venatorx Pharmaceuticals and the Global Antibiotic Research and Development Partnership (GARDP) today announced a collaboration to accelerate the development of, and access to, cefepime-taniborbactam (formerly cefepime/VNRX-5133). Cefepime-taniborbactam is an investigational combination of the fourth-generation antibiotic cefepime with taniborbactam, a novel, broad-spectrum beta-lactamase inhibitor that restores the activity of cefepime against carbapenem-resistant Enterobacterales (CRE) and carbapenem-resistant Pseudomonas aeruginosa (CRPA).
GARDP will collaborate with Venatorx to complete the development of cefepime-taniborbactam, which includes a phase 3 complicated urinary tract infection (cUTI) trial, which is already in progress; additional clinical trials in adults with multidrug-resistant infections; and clinical development activities and trials to enable cefepime-taniborbactam to be used for children, including newborns with serious bacterial infections.
Venatorx is committed to working with GARDP to distribute cefepime-taniborbactam on an affordable basis worldwide. Venatorx has granted GARDP exclusive rights to distribute and sub-distribute cefepime-taniborbactam, once it is approved for clinical use, in most low- and lower middle-income countries.
The World Health Organization has identified CRE and CRPA as 'critical-level' pathogens posing the greatest threat to global health and urgently requiring new antibiotics. These pathogens are most common in healthcare settings and are among the major causes of disability and death in these places. Bacteria can enter the body through wounds and surgery sites, ventilators and catheters, potentially leading to lung, urinary tract, abdominal and bloodstream infections.
In Europe, hospital infections are responsible for 37,000 attributable deaths annually, whereas in the United States, 98,000 deaths are attributed to hospital infections annually. While there are limited surveillance systems in low- and middle-income countries, indicators point to a higher burden of hospital infections.
Many of the pathogens responsible for these infections have become increasingly resistant to first-line antibiotics and are often treated with the carbapenem class of antibiotics, usually reserved for the most serious infections including multidrug-resistant infections. However, since the introduction of this class of antibiotics in the 1980s, pathogens have progressively developed carbapenem-resistance.
Antibiotic resistance presents a growing public threat and is exacerbated by global pandemics such as COVID-19. A recent study published in The Lancet showed that 98% of hospitalized COVID-19 patients received concomitant antibiotic therapy and that 50% of those who died also had secondary bacterial infections. The need for effective, broad spectrum antibiotics - both intravenous and oral - is critical, now more than ever. Our partnership with GARDP comes at a vital time to safeguard our ability to advance cefepime-taniborbactam through phase 3 clinical trials and afford access to patients, including children, who are more susceptible to hard-to-treat bacterial infections."
Christopher J. Burns, Ph.D., President and CEO of Venatorx Pharmaceuticals
"More than a hundred thousand people die every year in high-income countries due to hospital infections and indicators point to a significantly higher burden in low- and middle-income countries," said Dr. Manica Balasegaram, Executive Director of GARDP. "Our collaboration with Venatorx enables us to accelerate the development of a critically needed treatment for antibiotic-resistant infections in adults and children. Significantly, we are committed to working together to ensure this treatment is available to everyone who needs it, wherever they live. Just like COVID-19, antibiotic resistance is a health security crisis that moves silently and doesn't stop at national borders. No single country, company or organization can fight drug resistance alone. It can only be done in partnership."