Since 2016, CARB-X has accelerated a diverse portfolio of projects along the antibiotic pipeline
(BOSTON: March 5, 2024) — The Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) is celebrating support provided to 100 projects that address antibiotic resistance. Since it was founded in 2016, CARB-X has awarded US$452.6 million in non-dilutive funding to develop vaccines, diagnostics and therapeutics.
The award to the Helmholtz Institute for Pharmaceutical Research Saarland (HIPS) is the 100th project CARB-X has funded. CARB-X is awarding US$1.06 million to HIPS based in Saarbrücken, Germany, to develop a new class of small-molecule inhibitors of bacterial sliding clamp (DnaN), a pivotal component of DNA replication machinery, which is a clinically unproven but promising novel mechanism for targeting bacteria. These two degrees of novelty offer a potential advantage where the development of antibiotic resistance is concerned. The compounds display promising antibacterial activities against several pathogens that cause community-acquired bacterial pneumonia (CABP) and have the properties consistent with an oral therapy. With CARB-X support, HIPS will optimize these new molecules with the goal of advancing them into human clinical studies.
“With this 100th project, we are doubling-down on our support of novel approaches to deliver antibiotics that clinicians and patients need,” said Erin Duffy, PhD, R&D Chief of CARB-X. “If successful, the HIPS project will offer a workhorse antibiotic for community-acquired infections that will also take the pressure off antibiotics in the WHO model list of essential medicines.”
Lower respiratory tract infections, including CABP, are among the world’s deadliest communicable diseases. They are estimated to have killed 2.6 million people in 2019 globally, and they cause a substantial mortality, morbidity and economic burden for vulnerable people in low-income countries, where they are the second leading cause of death. More than 400,000 people globally died in 2019 due to lower respiratory tract infections attributable to drug-resistant bacteria, and even in a high-income country like the US, 22% of CABP cases result in treatment failure due to antibiotic resistance.
“Community-acquired pneumonia can be caused by a number of different pathogens,” explains Anna Hirsch, PhD, Department Head at HIPS and Full Professor at Saarland University. “With a molecular target that has not yet been clinically exploited, we aim for a new oral antibiotic for CABP to fill gaps left as our workhorse therapeutics have been rendered ineffective due to resistance.”
Since 2016, CARB-X has supported R&D projects in 13 countries, and CARB-X product developers have made tremendous progress: 18 projects have advanced into or completed first-in-human clinical trials; 12 remain active in clinical development, including in late-stage clinical trials; and two diagnostic products have reached the market. Additionally, at least nine product developers with active R&D projects have already secured advanced development partnerships which can help support their clinical development after leaving the CARB-X portfolio.
“When CARB-X started in 2016, the antibacterial pre-clinical pipeline looked promising but vulnerable. Even the teams with the most impactful ideas lacked the capital and support needed to advance their R&D products towards patients,” says Kevin Outterson, Executive Director of CARB-X and Austin B. Fletcher Professor of Law at Boston University. “CARB-X stood in the gap and, eight years later, we have clear proof that our model is working. Universities, research institutes, and small companies are innovating with powerful programs and CARB-X is here to translate the cream of the crop into human clinical trials. We are extremely grateful for the support of the growing number of funders to CARB-X for making this progress possible.”
An estimated 1.27 million people died due to drug-resistant bacterial infections in 2019, a death toll that exceeded HIV/AIDS (864,000) and malaria (643,000) in that same year. CARB-X is building a pipeline of high-value products to prevent, diagnose and treat bacterial infections, including those that have become resistant to antibiotics. CARB-X emphasizes performance characteristics that will allow the broadest use of these products against infections driving the greatest global morbidity and mortality.
In 2022, CARB-X launched funding rounds to support R&D projects and fill critical gaps in the antibacterial pipeline. These include oral therapeutics to replace the workhorse antibiotics that are failing; vaccines for neonatal sepsis, which kills 2.5 million infants annually; and oral therapeutics, vaccines and rapid diagnostics for gonorrhea. Resistant strains of gonorrhea have evaded all but one existing antibiotic. Stay tuned for CARB-X announcements and register for the CARB-X newsletter to learn about funding calls that will be announced in 2024.
CARB-X funding for this research 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), Germany’s Federal Ministry of Education and Research (BMBF), the UK Department of Health and Social Care as part of 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: Genevieve Holmes, carbxpr@bu.edu
HIPS Contact: hips.medien@helmholtz-hips.de
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 Helmholtz Centre for Infection Research
Scientists at the Helmholtz Centre for Infection Research (HZI) in Braunschweig and other locations in Germany study bacterial and viral infections and the body’s defense mechanisms. They have in-depth expertise in natural product research and its use as a valuable source for novel anti-infectives. As a member of the Helmholtz Association and the German Centre for Infection Research (DZIF), the HZI conducts translational research to lay the foundations for the development of novel therapies and vaccines against infectious diseases. www.helmholtz-hzi.de
About Helmholtz Institute for Pharmaceutical Research Saarland
The Helmholtz Institute for Pharmaceutical Research Saarland (HIPS) in Saarbrücken was founded jointly by the HZI and Saarland University in 2009. Scientists at HIPS develop and employ experimental and computational approaches to provide new active substances against infectious diseases, optimise them for use in humans and investigate how they can best be transported to their site of action in the human body. A special focus of the institute is on microbial natural products from soil bacteria and the human microbiota as well as innovative medicinal chemistry-driven approaches. www.helmholtz-hips.de
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 preparednessfor, 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 and is one of the leading public sector funders of advanced development of antimicrobial therapeutics and 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.
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 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 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 71 leading research universities in the United States and Canada. For further information, please contact Kim Miragliuolo at kmira@bu.edu. www.bu.edu