The federal government today issued a contract for advanced research and development of a dual-purpose broad spectrum antibiotic with potential to treat illnesses caused by bioterrorism threats such as plague and tularemia, as well as more certain life-threatening infections, known as Gram-negative infections, associated with prolonged hospitalization.
The U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) awarded the contract to GlaxoSmithKline of Philadelphia for advanced research and development for an antibiotic called GSK2251052. The drug would represent the first new class of antibacterial agent to treat Gram-negative infections in 30 years.
The contact is for $38.5 million in the first two years and can be extended for a total of four years, up to a total of $94 million. Under the contract, BARDA will provide technical and financial support for the development of GSK2251052, sharing the cost and drug development risk.
“To help providers protect health and save lives in an emergency and every day, we will need to develop the next generation of antibiotics,” says BARDA Director Robin Robinson, Ph.D. “This commercial-plus-biodefense strategy creates a sustainable, cost-effective business model for private industry and taxpayers, and it promotes a warm base manufacturing capability for use in a public health emergency.”
GlaxoSmithKline had been developing GSK2251052 for ventilator-associated pneumonia, complicated urinary tract infections, and complicated intra-abdominal infections, in which an operation would not remove all of the infected tissue.
Today’s contract support studies to evaluate the efficacy of GSK2251052 against bioterrorism threats, Phase II clinical trials using the drug to treat ventilator-associated pneumonia, and Phase III clinical trials using the drug to treat complicated intra-abdominal infections.
In addition, the contract will support initial laboratory testing to determine if the drug also provides protection against multi-drug resistant pathogens, including those containing the New Delhi Metallo-beta-lactamase-1 (NDM-1) resistance gene. Bacteria that carry the NDM-1 gene are resistant to almost all routine antibiotics healthcare providers use for these infections.
This contract aligns with the new approach to developing medical countermeasures recommended last year in the medical countermeasure review requested by HHS Secretary Kathleen Sebelius. One element of this new approach is to develop broad spectrum medical countermeasures for biological threat agents that can also address common public health threats such as multi-drug resistant bacterial infections.
The contract is the third to be funded under the resulting new Broad Spectrum Antimicrobials Program led by BARDA. BARDA is seeking additional proposals for broad-spectrum antimicrobials that could potentially treat or prevent illness due to biological threat agents.
BARDA, within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides a comprehensive integrated portfolio approach to the advanced research and development, stockpile acquisition, innovation, and manufacturing infrastructure building for vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products necessary to respond to public health medical emergencies. This includes response activities for chemical, biological, radiological, and nuclear threats, as well as pandemic influenza and emerging infectious diseases.