Government to partner with pharma company to develop antibiotic for drug-resistant infections

July 23, 2019

The Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) announced it will collaborate with the Department of Defense’s Defense Threat Reduction Agency (DTRA) and VenatoRx Pharmaceuticals, Inc. of Malvern, PA, to develop a novel antibiotic to treat infections caused by bacteria resistant to currently available agents.

The Centers for Disease Control and Prevention designated antibiotic-resistant infections, including infections such as carbapenem-resistant Enterobacteriaceae (CRE), as urgent public health threats. CDC estimates that antibiotic-resistant infections affect at least two million people in the United States each year and drive $35 billion in healthcare system costs annually.

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.

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VenatoRx’s product includes a novel compound, VNRX-5133, which when combined with cefepime, a currently marketed antibiotic, may overcome certain forms of antibiotic resistance. This approach could enable cefepime/VNRX-5133 to treat infections caused by some drug-resistant bacteria not susceptible to currently available antibiotics.

Cefepime/VNRX-5133 holds potential as an intravenous treatment for drug-resistant gram-negative infections that cause complicated urinary tract infections (cUTI), hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, as well as the potential bioterrorism pathogens that cause glanders and melioidosis.

ASPR’s interest in antibiotic-resistant infections stems from the need for biodefense preparedness. Terrorists or nation states can develop antibiotic-resistant pathogens for use in bioterrorism. In addition, after chemical, biological, radiological or nuclear emergencies, survivors can develop secondary infections that are resistant to antibiotics. In this way, antibiotic resistance complicates any emergency.

BARDA will provide up to $20.7 million over two years to VenatoRx under a cost-sharing contract to support the development and studies needed for submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing authorization of cefepime/VNRX-5133 to treat cUTI. The contract can be extended to provide up to a total cost-share of $86.8 million over six years.

BARDA and VenatoRx will share the costs of all studies needed to bring the drug to market, including 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 cefepime/VNRX-5133 in the treatment of melioidosis and glanders. VenatoRx will lead all regulatory activities needed to seek FDA approval of cefepime/VNRX-5133 under this cost-sharing contract.

In parallel with the BARDA-supported work, DTRA will provide up to $10 million through its bacterial Rapid Acquisition Platform program to fund the nonclinical biodefense aspects of the inter-agency collaboration. This work includes execution of non-clinical potency and efficacy studies to test cefepime/VNRX-5133 against biothreat bacterial pathogens, beginning with Burkholderia pseudomallei, which causes melioidosis.

This project is the second under an ASPR-DTRA partnership agreement signed in October 2018. With cefepime/VNRX-5133, BARDA’s development portfolio includes 15 products to combat antimicrobial resistant infections that pose bioterrorism and urgent public health threats, in addition to 29 therapeutics, one vaccine, and five diagnostics being developed with BARDA funding under the CARB-X partnership.