New funding will support multilateral efforts to save lives globally
(BOSTON: October 16, 2024) – The Government of Italy has announced a commitment of US$21 million over the next three years to support the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X). The announcement was made at the G7 Joint Finance and Health Ministers’ Meeting in Ancona on October 10, 2024.
The grant from Italy will enhance CARB-X’s efforts to advance the early-stage development of innovative products aimed at preventing, diagnosing, and treating drug-resistant bacterial infections, a leading cause of death around the world, particularly in low- and middle-income countries (LMICs). New data published in September 2024 estimates that a regular release of new, potent antibiotics targeting Gram-negative bacteria, which is part of CARB-X’s mission, could avert 11.1 million cumulative deaths caused by antimicrobial resistance (AMR) in the coming 25 years, with the largest reductions in South Asia, Southeast Asia, East Asia and Oceania, and sub-Saharan Africa. The economic benefits would also be significant: introducing new Gram-negative antibiotics would reduce health care costs by US$84 billion, generate improved health outcomes worth US$174 billion, and add US$740 billion to global GDP per year by 2050.
Building on the initiatives of previous G7 Presidencies, AMR has been a central focus of the Italian Presidency this year. In May in Stresa, G7 Finance Ministers agreed to “continue discussing instruments to … promote research, including into new antimicrobials as well as alternatives to their use, through push and pull incentives.” In June in Apulia, G7 leaders confirmed that they will “implement push and pull incentives, support public-private partnerships and explore innovative instruments to accelerate research and development on new antimicrobials, their alternatives, and diagnostics.” In October in Ancona, G7 Health Ministers committed to “support funding for push incentives, including contributing to existing global pooled efforts to accelerate R&D of novel antimicrobials, vaccines and diagnostics and alternative therapeutics.”
Prof. Kevin Outterson, CARB-X Executive Director, was invited by the Italian Government to deliver the keynote address at the G7 Joint Finance and Health Ministers’ Meeting in Ancona on October 10, 2024. He presented the latest evidence on the status of the global antibacterial pipeline and the projected burden of drug-resistant bacterial infections at current funding levels. Prof. Outterson also showcased a simulation exercise illustrating the potential impact of various investment scenarios on future antibiotic approvals and key health and economic indicators. The presentation underscored the inadequacy of the clinical pipeline to address the threat of drug-resistant infections and highlighted the need for urgent action by governments around the world.
“We are profoundly grateful to the Italian Government for their generous support,” said Kevin Outterson, Executive Director of CARB-X and Austin B. Fletcher Professor of Law at Boston University. “Italy’s investment is a powerful addition to the support we receive from our global consortium of funders, including other G7 governments and leading global health foundations. This collective effort underscores the critical importance of international collaboration in the fight against AMR. Together, we are driving innovation and ensuring that the most promising research can be translated into life-saving treatments for patients worldwide.”
When CARB-X was founded in 2016, the early-stage antibiotic pipeline was stalled. Since its inception, CARB-X has supported 104 R&D projects in 13 countries, and CARB-X product developers have made significant progress: 18 projects have advanced into or completed clinical trials; 12 remain active in clinical development, including late-stage clinical trials; and two diagnostic products have reached the market. Additionally, at least 9 product developers with active R&D projects have already secured advanced development partnerships to support their clinical development after leaving the CARB-X portfolio. All CARB-X-funded product developers are contractually obligated to develop a Stewardship and Access Plan for their funded product, outlining strategies to ensure responsible stewardship and appropriate access in LMICs.
CARB-X focuses on the most serious drug-resistant bacteria and the syndromes with the highest degrees of mortality and morbidity, both of which also have a particularly high burden in LMICs. In the 2022-2023 funding round, CARB-X accepted applications for vaccines for neonatal sepsis. The BARNARDS study estimated that 2.5 million neonates or infants in the first month of life die annually of sepsis, with the greatest burden in LMICs. The funding round also called for products to treat, diagnose, and prevent gonorrhea, a sexually-transmitted infection that infected 82 million people globally in 2020, with the highest prevalence of infection in LMICs. In the 2024 funding round, CARB-X called for applications to demonstrate proof-of-concept for alternative sample types for diagnosing lower-respiratory tract infections, which have been estimated to have killed 2.6 million people in 2019 globally. Lower-respiratory tract infections cause a substantial mortality, morbidity and economic burden for vulnerable people in LMICs.
CARB-X is funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under agreement number 75A50122C00028 and by awards from Wellcome (WT224842), Germany’s Federal Ministry of Education and Research (BMBF), the Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Public Health Agency of Canada (PHAC), the Bill & Melinda Gates Foundation, and the Novo Nordisk Foundation. The U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in HHS, provides support in the form of in-kind services through access to a suite of preclinical services for product development. The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of any CARB-X funders.
CARB-X Contact: Marissa Novel, carbxpr@bu.edu
About CARB-X
CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) is a global non-profit partnership dedicated to supporting early-stage antibacterial research and development to address the rising threat of drug-resistant bacteria. CARB-X supports innovative therapeutics, preventatives and rapid diagnostics. CARB-X is led by Boston University and funded by a consortium of governments and foundations. CARB-X funds only projects that target drug-resistant bacteria highlighted on the CDC’s Antibiotic Resistant Threats list, or the Priority Bacterial Pathogens list published by the WHO, with a priority on those pathogens deemed Serious or Urgent on the CDC list or Critical or High on the WHO list. https://carb-x.org/ | X (formerly Twitter) @CARB_X
About BARDA and NIAID
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. The Administration for Strategic Preparedness and Response (ASPR) leads the nation’s medical and public health preparedness for, response to and recovery from disaster and other public health emergencies. Within ASPR, the Biomedical Advanced Research and Development Authority (BARDA) invests in innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products – needed to combat health security threats. BARDA is one of the leading public sector funders of advanced development of antimicrobial therapeutics and diagnostics worldwide, having invested more than $2.4 billion in antimicrobial products since 2010. This investment has supported the development of over 160 antimicrobial products and led to the U.S. Food and Drug Administration (FDA) approval of four new antibiotics and FDA 510(k) clearance of eight diagnostics.
As part of HHS, 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. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.
As part of HHS, 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. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.
About Wellcome
Wellcome supports science to solve the urgent health challenges facing everyone. We support discovery research into life, health and wellbeing, and we’re taking on three worldwide health challenges: mental health, infectious disease and climate and health.
About the German Federal Ministry of Education and Research (BMBF)
Education and research are crucial foundations for our future. Thus, the promotion of education, science and research is a policy priority of the German Federal Government. The German Federal Ministry of Education and Research (BMBF) strengthens education at all stages of life and provides support for scientific research and innovation.
About the Global AMR Innovation Fund (GAMRIF)
The Global AMR Innovation Fund (GAMRIF) is a One Health aid fund that supports research and development around the world to reduce the threat of antimicrobial resistance (AMR) in humans, animals and the environment for the benefit of people in low- and middle-income countries (LMICs). GAMRIF core objectives are to develop innovative One Health solutions to tackle AMR; increase availability of context-specific, accessible, and affordable innovations for LMICs; establish international research partnerships with industry, academia, and governments; and collaborate with and leverage additional funding from other global donors.
About the Public Health Agency of Canada
The Public Health Agency of Canada is an agency of the Government of Canada that is responsible for public health, emergency preparedness and response, and infectious and chronic disease control and prevention. Created in 2004 with a mission to promote and protect the health of Canadians through leadership, partnership, innovation and action in public health, the Agency’s activities focus on preventing disease and injuries, responding to public health threats, promoting good physical and mental health, and providing information to support informed decision making. The Agency has a long history of working with domestic and international partners on combatting health threats, including AMR. Most recently, the Agency released the Pan-Canadian Action Plan on AMR, a multijurisdictional effort that emphasizes One Health collaboration to make progress on AMR.
About the Novo Nordisk Foundation
Established in Denmark in 1924, the Novo Nordisk Foundation is an enterprise foundation with philanthropic objectives. The vision of the Foundation is to improve people’s health and the sustainability of society and the planet. The Foundation’s mission is to progress research and innovation in the prevention and treatment of cardiometabolic and infectious diseases as well as to advance knowledge and solutions to support a green transformation of society.
About Boston University
Founded in 1839, Boston University is an internationally recognized institution of higher education and research. With nearly 37,000 students, it is one of the largest private residential universities in the United States. BU consists of 17 schools and colleges, along with the Faculty of Computing & Data Sciences and a number of multi-disciplinary centers and institutes integral to the University’s research and teaching mission. In 2012, BU joined the Association of American Universities (AAU), a consortium of leading research universities in the United States and Canada. For further information, please contact Kim Miragliuolo at kmira@bu.edu. www.bu.edu