Millions earmarked to boost research into new life-saving products for the global population

(BOSTON: August 10, 2023) – During the 2023 World Health Assembly, the UK government announced support for cutting-edge research initiatives to develop new treatments to tackle antimicrobial resistance (AMR). Through its Global AMR Innovation Fund (GAMRIF), the UK government has committed up to £24 million to CARB-X over the next four years to support the continued early development of innovative products that aim to prevent, diagnose and treat drug-resistant bacterial infections which are estimated to have caused 1.27 million deaths in 2019, more deaths than from HIV/AIDS or malaria in that same year.

Preventing unnecessary deaths and disease around the world, with a direct benefit for people in low- and middle-income countries (LMICs), the ultimate objective of this investment is to reduce the threat of AMR and save lives. The UK government had already given £20 million of its ringfenced Official Development Assistance (ODA) budget to the initiative which, together with other funders, has resulted in CARB-X accelerating 92 R&D projects since 2017. Among them, 18 have entered or completed first-in human clinical trials, 13 are in active clinical development, seven have secured advanced development partnerships, and two are on the market.

The UK government has a strong track record of bolstering international efforts aimed at addressing AMR. For example, it made AMR one of the priorities for its G7 Presidency in 2021. At the Carbis Bay Summit, G7 leaders committed to “act now to strengthen the global health and health security system to be better prepared for future pandemics and to tackle long standing global health threats, including Antimicrobial Resistance.” The G7 Health Ministers recognised “the importance of the research and development in new and innovative antimicrobials as well as alternatives to antimicrobials; vaccines, diagnostics and other countermeasures” highlighting initiatives including CARB-X. In June 2023, the United States and the United Kingdom announced the Atlantic Declaration for a Twenty-First Century U.S.-UK Economic Partnership, where the two governments committed to increase their “collaboration to overcome the market failures that prevent vital research and development of anti-microbial vaccines, therapeutics, and diagnostics – via mechanisms such as CARB-X.”

“AMR threatens modern medical systems for current and future generations,” said Professor Dame Sally Davies, UK Special Envoy on AMR. “I am proud that CARB-X’s global partnership and commitment to cutting-edge innovation, equitable global access, and sustainable stewardship will bring exciting new treatments, preventatives and diagnostics to those across the world who most need them. I am delighted that the UK government and our international partners are supporting CARB-X to accelerate solutions to the grand pandemic of AMR.”

Aligned with its mission, the UK government, through GAMRIF, have funded CARB-X projects that could benefit everyone, especially people living in LMICs, where the AMR burden is the greatest. Since 2018, GAMRIF has supported antibacterial products and vaccines that are designed for affordability and to overcome common infrastructure challenges. Active portfolio projects include:

• The GSK Vaccines Institute for Global Health (GVGH) iNTS-TCV vaccine aims to affordably protect against both invasive non-typhoidal Salmonella (iNTS) and typhoid fever, which are associated with antibiotic resistance, and in extreme cases can result in bloodstream infections. No vaccine is currently available for iNTS, a major cause of death in sub-Saharan Africa. In 2022, GVGH began administering the iNTS-TCV vaccine in a Phase 1 clinical trial that will include patients in Europe and Africa.
• The Jenner Institute’s Native Outer Membrane Vesicles (NOMV) vaccine aims to affordably prevent global gonorrhea infections, including those caused by drug-resistant strains. Gonorrhea affected an estimated 82 million people in 2020–the burden disproportionately impacts people of marginalized sexual, gender, racial and ethnic groups. Once there were many antibiotics that could treat gonorrhea. Today only ceftriaxone remains effective.
• Lumen Bioscience’s oral antibody-based cocktail targets Campylobacter jejuni and enterotoxigenic Escherichia coli (ETEC) to prevent life-threatening diarrheal diseases which kill over 800,000 children per year, more than malaria, measles and HIV/AIDS combined. Lumen uses a spirulina-based platform, derived from food algae. The low-cost oral product could be easily shipped and stored without cold chain distribution.
• Macro Biologics’ Amicidin-β synthetic protein aims to treat orthopedic and trauma-related infections, including from emergency surgeries, like cesarean deliveries. These represent more than 50% of surgical procedures in sub-Saharan Africa, where up to 20% of mothers develop infections. The team has developed formulations of the protein that will enable optimal coverage, cleansing and killing bacteria in infected body sites.

Furthermore, CARB-X leads a series of research projects called Portfolio Acceleration Tools (PATs) to address common challenges and share knowledge that could benefit the AMR ecosystem. GAMRIF funded a PAT that provided CARB-X product developers with global bacterial strains, genotypic data, and blinded challenge panels to optimize their antibiotics, preventatives and rapid diagnostics. The goal was to ensure that CARB-X projects will work effectively in populations around the world, and to help advance them more affordably and quickly to patients.

“We are deeply grateful that the UK government and our international partners serve as world leaders on AMR action and awareness,” said Kevin Outterson, Executive Director of CARB-X and Austin B. Fletcher Professor of Law at Boston University. “Millions of people around the world, especially in LMICs, are vulnerable to bacterial infections which are failing to respond to existing antibiotics. CARB-X is committed to accelerate a pipeline of products which meet their needs.”

CARB-X is funded in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; under Agreement number: 75A50122C00028. CARB-X is also funded by awards from Wellcome (WT224842), Germany’s Federal Ministry of Education and Research (BMBF), the UK Global Antimicrobial Resistance Innovation Fund (GAMRIF) funded by the UK Government Department of Health and Social Care (DHSC), and the Bill & Melinda Gates Foundation. 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: Robin Berghaus, 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/ | 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 HHS in preparing the nation to respond to and recovery from the adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security. 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. 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.

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 UK 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 Boston University
Founded in 1839, Boston University is an internationally recognized institution of higher education and research. With nearly 37,000 students, it is the third-largest independent university in the United States. BU consists of 17 schools and colleges and the interdisciplinary Faculty of Computing & Data Sciences, along with 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 65 leading research universities in the United States and Canada. For further information, please contact Kim Miragliuolo at kmira@bu.edu. www.bu.edu