The federal government is providing up to $97 million to help VenatoRx Pharmaceuticals develop a novel compound to target one of the world's fastest-growing health threats: superbugs.
The U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR) will collaborate with Department of Defense's (DOD's) Defense Threat Reduction Agency (DTRA) and the Pennsylvania-based pharmaceutical company to develop the novel antibiotic compound.
It will be aimed at treating infections caused by bacteria resistant to currently available drugs.
VenatoRx has a product that includes a novel compound called VNRX-5133, which when combined with cefepime, a currently marketed antibiotic, may overcome certain forms of antibiotic resistance to treat infections caused by some drug-resistant bacteria not susceptible to currently available antibiotics.
Officials said the combination would have the potential to be used as an intravenous treatment for drug-resistant gram-negative infections that cause complicated urinary tract infections, hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. It could also be used to target potential bioterrorism pathogens.
Antibiotic-resistant infections, such as carbapenem-resistant Enterobacteriaceae (CRE), have been named urgent public health threats by the Centers for Disease Control and Prevention (CDC). The CDC estimates antibiotic-resistant infections affect at least 2 million people every year and cost the healthcare industry $35 billion annually.
But officials said in a statement that ASPR’s interest in antibiotic-resistant infections stems from the need for biodefense preparedness against terrorists or nation-states that could develop antibiotic-resistant pathogens for use in bioterrorism.
“Developing new antibiotics that represent an improvement over standard of care antibiotics is essential to national health security and global health efforts to combat antibiotic-resistant infections,” said Rick Bright, director of the Biomedical Advanced Research and Development Authority (BARDA), in a statement. “This unique public-private partnership will focus on adding a new tool to healthcare providers’ toolkits and to help them save lives in an incident involving some of the serious bioterrorism threats our country faces.”
Under a cost-sharing agreement, BARDA will provide up to $20.7 million over two years to VenatoRx to support the development and studies needed for submission of a New Drug Application to the U.S. Food and Drug Administration (FDA).
They will also share the costs of planned pivotal phase 3 clinical trials to treat cUTI, hospital-acquired and ventilator-associated bacterial pneumonia, carbapenem-resistant pathogens and a data package to potentially support the use of the combination agent against bioterrorism.
The contract can be extended to a total cost share of $86.8 million over six years. VenatoRx will lead all regulatory activities needed to seek FDA approval.
At the same time, DTRA will provide up to $10 million to fund the nonclinical biodefense aspects of the interagency collaboration including the execution of nonclinical potency and efficacy studies to test cefepime/VNRX-5133 against biothreat bacterial pathogens.
"These joint programs will ensure that we deliver FDA-approved therapies to the U.S. military forces to combat the threat of antibiotic-resistant bioterrorism,” Ron Hann, director of the Chemical Biological Technologies Department in DTRA’s Research and Development Directorate, said in a statement.
If successful, this therapy would increase treatment options for patients with antibiotic-resistant gram-negative infections, potentially reducing the cost and complications associated with extended hospital stays. This project is the second under an ASPR-DTRA partnership agreement signed in October.