(HELLERUP and BOSTON: January 9, 2024) – The Novo Nordisk Foundation is committing up to USD 25 million to support the early-stage development of innovative tools to prevent, diagnose and treat the most dangerous drug-resistant bacterial infections. The three-year grant will go to the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), the leading global non-profit public-private partnership in this space.
Antimicrobials, including antibiotics, are the world’s primary defence against infections. But when the bacteria, viruses, fungi or parasites that cause those infections mutate and become resistant to existing treatments, simple infections can lead to severe illness or death.
Antimicrobial resistance (AMR) threatens to unravel societies and the global economic system by increasing the risks of performing routine medical procedures such as caesarean sections, hip replacements and chemotherapy, impairing our food chain, and diminishing productivity. The most comprehensive assessment of the burden of AMR to date found that drug-resistant bacterial infections alone caused an estimated 3,500 deaths every day in 2019, a number on the rise and already higher than both HIV/AIDS and malaria. According to the World Bank, in a high AMR-impact scenario, the world would lose 3.8 percent of its annual GDP by 2050, with an annual shortfall of $3.4 trillion by 2030.
A key part of the solution is the development of new vaccines, diagnostic tools, antibiotics, and other innovative interventions that can help prevent these infections, diagnose them quickly and accurately, and treat them effectively. Yet, most major pharmaceutical companies have exited the market and those left in the early development space tend to be academic spinouts and small companies in need of grants and guidance.
CARB-X, a global non-profit partnership funded by four G7 governments and three of the world’s biggest foundations, is a leading provider of support to these product developers. The partnership, therefore, plays a crucial role in moving promising ideas for cutting-edge antibacterial products from basic research to clinical development and through Phase 1 clinical trials. Since 2016, CARB-X has funded 93 projects in 12 countries. Nineteen 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.
“Like CARB-X, the Novo Nordisk Foundation is committed to driving innovation in the fight against drug-resistant infections,” says Peter Lawætz Andersen, Senior Vice President in Infectious Disease at the Foundation. “By partnering, we can help ensure that the best research gets translated into effective, scalable and affordable medical interventions that can help end this growing pandemic.”
“CARB-X is grateful for this generous contribution from the Novo Nordisk Foundation, a key ally in CARB-X’s mission,” says Kevin Outterson, Executive Director of CARB-X and Austin B. Fletcher Professor of Law at Boston University. “This new funding is a testament to our shared commitment to supporting the pioneering efforts of antibacterial product developers, mainly university spinoffs and small biotech companies, in advancing much-needed innovation to prevent, diagnose and treat the most dangerous drug-resistant bacterial infections.”
Battling a broken market
Despite the importance of antibiotics in modern medicine, only two new classes (types) have reached the market since 1962 and there are very few in clinical development. According to the World Health Organization, “the clinical pipeline and the recently approved antibacterial agents are insufficient to tackle the challenge of increasing emergence and the spread of AMR.”
Private investments in innovative antibiotics are poor partly because doctors use them only when older and cheaper drugs fail. This is important to prolong their effectiveness, but it also limits their sales. This broken market has created a huge funding gap in antibacterial product development. A report for the European Commission has recently estimated that an additional global investment of USD 250 to 400 million from public and philanthropic sources is needed every year for the R&D of products that counter drug resistance, and that this investment should focus in the early phase of development, which is where CARB-X operates.
Novo Holdings – the Foundation’s wholly owned subsidiary – established the REPAIR (Replenishing and Enabling the Pipeline for Anti-Infective Resistance) Impact Fund in 2018 to address this early-stage funding gap. While continuing to support the existing portfolio, REPAIR has paused new investments due to the challenging market conditions, with the Foundation now supporting the critical early-stage pipeline via the philanthropic grant to CARB-X.
Developing cutting-edge products
The grant is also part of a broader commitment from the Foundation and Novo Holdings to fight drug resistance through the development of innovative products. The organisations are engaged in a range of activities from early development to advocating for payment models that can help rejuvenate the market for antimicrobials. The Foundation is also funding a major new initiative – the Novo Nordisk Foundation Initiative for Vaccines and Immunity – that will reduce the use of antibiotics and thus the spread of AMR by developing vaccines against respiratory infections.
With this grant, the Novo Nordisk Foundation joins major governments and foundations in supporting the work of CARB-X. Efforts are focused on the most dangerous bacteria which have been prioritized by the World Health Organization and the United States Centers for Disease Control and Prevention (CDC), the syndromes with the greatest morbidity and mortality across the world, and the performance characteristics that clinicians and patients need the most. Beyond non-dilutive funding, CARB-X provides grantees with scientific, clinical, regulatory, and business development guidance and access to tools that aim to accelerate product development.
Novo Nordisk Foundation Contact:
Judith Vonberg, +45 4172 7925, jvo@novo.dk
CARB-X Contact: Genevieve Holmes, carbxpr@bu.edu
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.
www.novonordiskfonden.dk/en
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
CARB-X is supported by 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; under agreement number 75A50122C00028, and by awards from Wellcome (WT224842) and 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), 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.
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 disasters 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 and is one of the leading public sector funders of advanced development of antimicrobial therapeutics and diagnostics.
As part of HHS, the National Institutes of Health (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. Within NIH, the National Institute of Allergy and Infectious Diseases conducts and supports research — 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 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