HHS funds late-stage development, potential purchase of new antibiotic to combat a biothreat, treat antibiotic resistant infections

As part of ongoing national preparedness efforts for biological emergencies, the U.S. Department of Health and Human Services (HHS) will fund the late-stage development of an antibiotic being developed by Venatorx Pharmaceuticals, Inc., of Malvern, Pennsylvania. HHS also will purchase a supply of the drug if specific development milestones are met.

The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Administration for Strategic Preparedness and Response (ASPR), used authority under the 2004 Project Bioshield Act to award approximately $72 million in Project BioShield funding for this contract. If all options are awarded, the total contract value will be $318.6 million.

“Antimicrobial-resistant biothreats pose a risk to national health security due to limited treatment options and corresponding high mortality,” said BARDA Director Gary Disbrow, Ph.D. “Supporting the development of medical countermeasures for both emergency use and common medical needs reduces development and preparedness costs for taxpayers and expands the U.S. preparedness posture during emergency responses.”

The product combines a novel compound, taniborbactam, with cefepime, a marketed antibiotic, to overcome certain forms of antibiotic resistance. The antibiotic combination has potential to treat infections caused by bacteria that are resistant to carbapenems, an antibiotic class commonly used to treat severe bacterial infections.

With HHS support, cefepime-taniborbactam is being developed as a potential treatment for patients with melioidosis, a bacterial infection that also poses a potential bioterrorism threat to the U.S. Venatorx also is developing cefepime-taniborbactam to treat drug-resistant, complicated urinary tract infections in adults, as well as hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia.

Under the Project BioShield contract, Venatorx will conduct additional development activities including clinical, non-clinical, and CMC activities to support submission of a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for the use of cefepime-taniborbactam to treat melioidosis in adults. In addition, the contract supports post-licensure commitments as required by the FDA.

This contract follows an advanced research and development contract awarded to Venatorx in 2019 for development of cefepime-taniborbactam as a therapeutic option for treatment of melioidosis and pathogens classified as urgent drug-resistant public health threats by the Centers for Disease Control and Prevention (CDC).

Melioidosis, or Whitmore’s disease, can occur in people and animals and is caused by the bacterium Burkholderia pseudomallei, which can be found in contaminated soil and water. People become infected by bacteria during direct contact with the contaminated source. The disease often occurs in tropical climates; although considered a rare disease in the United States, B. pseudomallei was found along the Mississippi Gulf Coast in 2022. The bacterium is also a CDC Class B biothreat.

This contract is BARDA’s second Project Bioshield award to expand the nation’s preparedness posture to combat antibacterial biothreat pathogens and make life-saving products readily available to treat secondary drug-resistant bacterial infections following public health emergencies, such as chemical, biological, radiological, or nuclear incidents.

The contract is the latest step for ASPR in implementing components of the National Action Plan for Combating Antibiotic-Resistant Bacteria as well as the National Biodefense Strategy; both call for accelerating research and development of new antibiotics to combat antibiotic resistant infections.

Antimicrobial resistance is an urgent global public health threat, killing at least 1.27 million people worldwide and associated with nearly 5 million deaths in 2019, according to a report released earlier this year. In the U.S., more than 2.8 million antimicrobial-resistant infections occur each year and more than 35,000 people die as a result. According to a CDC collaborative study, the estimated national cost to treat infections caused by six multidrug-resistant germs frequently found in health care can be more than $4.6 billion annually.

About HHS, ASPR and BARDA

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products – needed to combat health security threats.