HHS Pledges up to $300 Million to Combat Antibiotic Resistance Bacteria

In a recent announcement, the Department of Health and Human Services (HHS) has pledged $20 million this year, and up to $300 million over the next 10 years, to combat antibiotic microbial resistance (AMR) infections through the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X). This collaboration is designed to advance the development of preventatives, therapeutics, and diagnostics for AMR infections.

“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 Dawn O’Connell, HHS Assistant Secretary for Preparedness and Response. “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,” she continued.

In 2016, CARB-X was developed 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 Gary Disbrow, PhD, BARDA Director. “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,” he added.

In agreement with BARDA, Wellcome will invest up to $70 million over the next three years to combat the escalating threat of drug-resistant infections.

While CARB-X, led by Boston University, is the world’s largest private–public partnership devoted to the early development of AMR products, additional funding partners include the governments of Germany and the United Kingdom and the Bill & Melinda Gates Foundation. These organizational agreements could be renewed in 2022 and 2023 to provide additional CARB-X support.

Since the start of the CARB-X program in 2016, private and public partnerships have invested a total of $503 million. Among the founding partners, BARDA and Wellcome have provided $200 million and $155 million, respectively, while the NIAID offers product development support.

Additionally, CARB-X offers wrap-around technical, business, and regulatory support to businesses for early-stage development, ensuring that a pipeline of candidates is positioned for advanced research and development by late-stage development funders.

As a part of its scientifically diverse portfolio, CARB-X has financially supported the advancement of 92 innovative projects in 12 countries, and 11 CARB-X-supported products related to antibiotic-resistant infections have progressed into first-in-human clinical trials, with more on the way for next year. Four diagnostics are primed for clinical trials and have been moved into the validation and verification stage. Two companies, formerly supported by CARB-X, have advanced to later stages of development and are now 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,” he explained.