U.S. and British officials announced an ambitious collaboration Thursday designed to accelerate the discovery and development of new antibiotics in the fight against one of the modern era’s greatest health threats: antibiotic resistance.
CARB-X, for Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, will create one of the world’s largest public-private partnerships focused on preclinical discovery and development of new antimicrobial products.
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 could provide hundreds of millions of dollars over five years to increase the number of antibiotics in the drug-development pipeline, according to a HHS release.
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 Trust. Historically, only about one in five 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.
These life-saving 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.
“Increasingly, it is becoming clear that partnerships of global reach and efficiency are needed to address complex problems like antimicrobial resistance,” Richard Hatchett, acting director of the Biomedical Advanced Research and Development Authority, said in a statement.
BARDA is the agency within HHS that 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, in overseeing the project for this country.
“The establishment of CARB-X is a watershed moment,” Hatchett said. “Governments, academia, industry and nongovernment organizations have come together to operate under a common strategic framework to tackle a monumental public health threat of our time.”
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.
Public health leaders said the project has tremendous potential to jumpstart 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 in to 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.
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.
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 “further funding” and its expertise in overseeing projects of this kind, according to the HHS release.
– 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.