The undertaking includes two agencies within the U.S. Health and Human Services Department that focus on biomedical research and Britain’s Wellcome Trust, a London-based global biomedical research charity. It also includes academic, industry and other nongovernmental organizations.
The partnership is committed to providing $44 million in funding in the first year and up to $350 million in new funds over five years to increase the number of antibiotics in the drug-development pipeline. The ultimate goal, officials said, is to move promising antibiotic candidates through the critical early stages so they can attract enough private or public investment for advanced development and win approval by U.S. and British regulatory agencies.
Biomedical innovations often take place in small companies and academic labs that don’t have the resources and expertise to move products to clinical development. CARB-X aims to provide necessary funding for research and development and technical assistance to move products from proof of concept through preclinical development.
Only 37 antibiotics are currently in clinical development in the United States, according to the Pew Charitable Trusts. Historically, only about 1 in 5 infectious-disease drugs that enter Phase 1 trials will receive approval from the Food and Drug Administration. There have been no new classes of antibiotics discovered since 1984, according to Pew’s antibiotic-resistance project.
“The establishment of CARB-X is a watershed moment,” Nicole Lurie, a top HHS official in charge of preparedness and response, said during a press briefing Thursday.
These lifesaving drugs are fundamental to modern medicine. They are essential for treating everything from routine skin infections to strep throat and for protecting vulnerable patients receiving chemotherapy or those hospitalized in intensive care units. But the speedy rise of antibiotic-resistant bacteria, which experts say is a result of decades of overuse in animal agriculture and human medicine combined with lagging drug development and innovation, has put people everywhere on the brink of what many public health leaders say is a “post-antibiotic” world. In such a world, even the most simple surgical procedure could have fatal consequences.
Overseeing the project on the U.S. side is the Biomedical Advanced Research and Development Authority, or BARDA. The HHS agency works on national preparedness for chemical and biological threats. It will be joined by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
On the British side, oversight will be led by the Wellcome Trust and the AMR Centre, a public-private initiative formed in February to spur development of new antibiotics and diagnostics.
“Today the world can be a little more optimistic that we can together tackle this challenge,” said Stephen Caddick, director of innovation for the Wellcome Trust.
Public health leaders said the project has tremendous potential to jump-start drug development.
“There are a lot of companies that have potential new antibiotics or other therapies, but it's a very tough environment to raise funds in,” said Allan Coukell, one of Pew’s top antibiotic experts. “The market for these products are generally small. Creating an economic incentive where they can tap into capital to get these products developed and also access some expertise has the potential to have a real impact.”
CARB-X will be headquartered at Boston University’s School of Law, where the project’s executive team will be led by Kevin Outterson, a leading health law researcher who will serve as principal investigator on the cooperative agreement.
Outterson said the initial focus will be on superbugs and other pathogens that the Centers for Disease Control and Prevention has deemed to be serious or urgent threats to public health. They include a particularly dangerous family of bacteria known as CRE, or carbapenem-resistant Enterobacteriaceae, which health officials have dubbed “nightmare bacteria.”
Two U.S. nonprofit life-science accelerators will provide support for early-stage antibiotic development projects: Massachusetts Biotechnology Council in Cambridge, Mass., and the California Life Sciences Institute of South San Francisco.
BARDA is already working directly with drug companies to support nine new antibiotics that could move into the market in the next one to three years, said Joe Larsen, acting deputy director at BARDA. The goal for CARB-X is to work on about 20 different drug candidates at any given time. “Our target is that at a minimum, two products make it to human testing in five years,” he said.
During the planning process, Larsen said industry and venture capital executives identified preclinical development as the largest need. Securing funding to conduct studies in animals is particularly challenging, and many trials fail in that phase.
NIAID Director Anthony Fauci said his institute would be able to provide the in-kind research and support services, such as animal models, for that crucial preclinical investigation.
Here is what each organization is committing:
•BARDA will provide $30 million during the first year and up to $250 million during the five-year project.
•The AMR Centre aims to provide $14 million in the first year and up to $100 million over five years.
•The Wellcome Trust will contribute additional funding from its existing resources and expertise in overseeing projects of this kind.
•NIAID, which leads the U.S. government in biomedical research on infectious diseases, will provide in-kind research support and technical support related to early-stage antibiotic drug discovery and product development.