Broad Spectrum Antimicrobials
Under the Project BioShield Act (2004) (PDF - 191 KB), Pandemic and All-Hazards Preparedness Act (2006) (PDF -248 KB), and Pandemic and All-Hazards Reauthorization Act (2013) (PDF - 284 KB), BARDA’s strategy to support advanced development of critical medical countermeasures targets biothreats that have been determined by the Department of Homeland Security as Material Threats. Guided by the BARDA Strategic Plan (2011-2016) (PDF - 2.31 MB) and PHEMCE Strategy and Implementation Plans (2012 and 2014), BARDA’s Broad Spectrum Antimicrobials Program uses novel public-private partnerships to incentivize research and development of novel antimicrobial drug candidates primarily through advanced development of drug candidates toward FDA approval. The product candidates funded by this program typically have broad spectrum activity across biothreats, including Bacillus anthracis (anthrax), Yersinia pestis (plague), Francisella tularensis (tularemia), Burkholderia mallei (glanders), B. pseudomallei (melioidosis) and other pathogens that could pose a threat to national or global security. Program investments ensure that therapeutic options are available in the event of drug resistance to antibiotics in the Strategic National Stockpile. Novel treatment options, as well as diagnostics to detect resistance, are critical to ensure timely, appropriate treatment of microbial infections.
To date, the Broad Spectrum Antimicrobials Program has supported advanced development of twelve (12) antimicrobial drug candidates. Four (4) of these are currently in Phase 3 clinical development for commercial indications (e.g. bacterial pneumonitis). In addition, the commercial indications have provided robust human safety datasets that are important for any biothreat indication. New Drug Application submissions for one (1) of these product candidates occurred in 2016 with two (2) additional applications anticipated in 2017.
This program also utilizes HHS’ Other Transactional Authority—the first usage since it was authorized through PAHPA in 2006. To-date, BARDA has established four (4) agreements with large pharmaceutical companies; GlaxoSmithKine (GSK), AstraZeneca, The Medicines Company, and Hoffmann-La Roche. The 5-year Other Transaction Agreements are flexible, innovative projects that allow BARDA to support a portfolio of candidate products in a novel way: resources and product candidates can move in and out of the program as technical risk and programmatic needs vary over time. These partnerships allow collaborative decisions on the strategic direction and composition of research and development portfolios to be made by BARDA and industry together. BARDA's strategy of addressing biothreats and pathogens that may pose a threat to national or global security has provided non-dilutive capital to companies that previously would have exited the antibiotic space because of the high risk and low return on investment.
The Combating Antimicrobial Resistant Bacteria (CARB) Initiative incorporates many of BARDA’s Broad Spectrum Antimicrobial Program’s efforts and directs BARDA to address antimicrobial resistance in pathogens of urgent or serious public health concern. This program will add to BARDA’s portfolio and encourage connections among MCM projects that are making available new diagnostic platforms and antimicrobials for bioterrorism threats, with added benefits for antimicrobial drug resistance in high priority public health pathogens.
In addition to supporting the CARB Initiative, BARDA launched CARB-X (combating antimicrobial resistant bacteria accelerator) in 2016. The Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, or CARB-X, was created to help address the threat of antibiotic resistance. CARB-X is one of the world’s largest public-private partnerships focused on preclinical discovery and development of new antimicrobial products.
CARB-X is a collaboration between NIAID and BARDA and four life science accelerators including the Wellcome Trust of London, the California Life Sciences Institute, Massachusetts Biotechnology Council, and the AMR Centre in the United Kingdom. Boston University is the lead institution for CARB-X. RTI International and the Broad Institute of MIT and Harvard have joined the partnership with RTI providing technical and research support services and Broad conducting early antibiotic discovery.
CARB-X partners are working together to accelerate antibacterial product development over the next 25 years. This partnership promotes innovation and could provide hundreds of millions of dollars over five years to increase the number of antibiotics in the drug-development pipeline.
CARB-X is working to set up a diverse portfolio with more than 20 high-quality antibacterial products. That’s dozens more than a company normally can take on. So the chances of getting innovative products into clinical testing within five years are higher than normal.
The end goal of CARB-X is to move promising antibiotic candidates through earlier stages of research and development, so that they merit private or public investment to advance to approval by the U.S. Food and Drug Administration and/or the Medicines and Healthcare products Regulatory Agency of the United Kingdom.