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The U.S. Department of Health and Human Services (HHS) announced it will commit $20 million this year and can provide up to $300 million over the next 10 years to fight antimicrobial resistant (AMR) infections through the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X). This public-private partnership is dedicated to accelerating the early development of therapeutics, preventatives and diagnostics for AMR infections.
While medications help treat and manage a wide variety of health issues, it’s important to understand that there is often a cost in the form of side effects that vary in intensity, antibiotics resistance being one of the most dangerous adverse reactions.
Antibiotic resistance happens when germs like bacteria and fungi develop the ability to defeat the drugs designed to kill them. That means the germs are not killed and continue to grow. More than 2.8 million antibiotic-resistant infections occur in the U.S. each year.
“Antibiotic resistance continues to grow at an alarming rate worldwide, killing an estimated 1.27 million people each year and affecting the U.S. and global economies,” said HHS Assistant Secretary for Preparedness and Response Dawn O’Connell. “To save lives and keep pace with that growing threat, we need to accelerate the development and delivery of innovative and effective antibiotics. CARB-X partners are responding to this challenge by reinvigorating the pipeline of early-stage AMR candidates to help fight deadly infections.”
CARB-X, led by Boston University, was launched in 2016 by the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR); the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health; and Wellcome, a global charitable foundation.
“AMR infections complicate the response to public health emergencies,” said BARDA Director Gary Disbrow, Ph.D. “We see a wealth of valuable basic and early discovery AMR research from around the world. Alongside our CARB-X global partners, we are helping transform this research into preclinical and clinical candidates that could be further developed into approved products to prevent and treat bacterial infections and, ultimately, save lives.”
In addition to non-dilutive funding, CARB-X provides wrap-around technical, regulatory, and business support to companies for early-stage development. This approach helps ensure that a pipeline of candidates is poised for advanced research and development by late-stage development funders.
Public and private partners have invested a total of $503 million in the CARB-X program since 2016. Among the founding partners, BARDA provided $200 million; Wellcome provided $155 million, and NIAID provided in-kind services to support product development through CARB-X.
Additional CARB-X funders and partners include the UK and German governments (the Global AMR Innovation Fund and the Federal Ministry of Education and Research), and the Bill & Melinda Gates Foundation. These additional organizations have agreements to support CARB-X that could be renewed in 2022 and 2023.
Alongside BARDA, Wellcome has agreed to provide up to $70 million over the next three years as part of its continued commitment to address the escalating threat of drug-resistant infections. The renewed funding from HHS and Wellcome will support the existing portfolio and allow for new funding rounds for CARB-X.
Since 2016, CARB-X has grown to become the world’s largest public-private partnership dedicated to early development of AMR products. CARB-X has funded the advancement of 92 innovative projects in 12 countries as part of a scientifically diverse portfolio.
Eleven CARB-X supported products to treat or prevent antibiotic-resistant infections have progressed into first-in-human clinical trials, with more expected to begin trials within the next year. Four diagnostics have progressed into the validation and verification stage, which primes them for pivotal clinical trials. Two companies formerly supported by CARB-X have advanced to later stages of development supported by BARDA.
“We are grateful for the leadership and commitment demonstrated by BARDA, NIAID, and Wellcome in addressing the global challenge of AMR bacteria,” said Kevin Outterson, executive director of CARB-X and professor of law at Boston University. “We now know that AMR kills more people each year than HIV or malaria, and a similar number to tuberculosis. With today’s funding announcements, CARB-X will continue to support early-stage research and development for new antibacterial therapies, preventives, and diagnostics.”
The U.S. Department of Health and Human Services 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. Within HHS, ASPR’s mission is to save lives and protect against health security threats. ASPR leads the nation’s medical and public health preparedness for, response to, and recovery from disasters and public health emergencies. As part of ASPR, BARDA provides a comprehensive, integrated, portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear agents, pandemic influenza, and emerging infectious diseases. NIH is the primary U.S. federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses.
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