CARB-X

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Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) is a global nonprofit partnership focused on supporting the development of new antibacterial products. Its mission is to strengthen the pipeline of vaccines, rapid diagnostics, antibiotics and non-traditional products to prevent, diagnose and treat life-threatening bacterial infections. [1]

Contents

CARB-X was launched in summer of 2016 at the Boston University School of Law, where Kevin Outterson, CARB-X Executive Director and Professor of Law, teaches health law, corporate law, and co-directs the Health Law Program. [2]

Antimicrobial resistance background

Bacteria are constantly evolving to evade death. Even the most powerful "last resort" drugs are becoming less effective due to resistance. [3] Without an arsenal of effective antibiotics to treat infections, modern medical procedures – such as chemotherapy and surgeries – are more risky and put patients' lives at risk. [4] Approximately 1.27 million people died [5] globally in 2019 due to drug-resistant bacterial infections. CARB-X supports projects that are focused on the most dangerous bacteria [6] identified by the World Health Organization (WHO) [7] and Centers for Disease Control and Prevention (CDC) priority lists. [8]

On average, it costs more than $1 billion and takes 1–15 years to develop a new antibiotic for use in patients. [9] A strong economic model to incentivize a steady supply of new antibiotics does not exist. Without enough revenue to recover research and development expenses, small antibiotic companies have been filing for bankruptcy, and large pharmaceutical companies are shuttering their antibiotics divisions. [10] New economic models, support from organizations like CARB-X, and increased investment are needed to drive innovation.

Funding

CARB-X receives funding from four governments and two nonprofit organizations. These include the US Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR); Wellcome Trust, a global charitable foundation; Germany's Federal Ministry of Education and Research (BMBF); the UK Government's Global Antimicrobial Resistance Innovation Fund (UK GAMRIF); the Bill & Melinda Gates Foundation; the government of Canada; and the Novo Nordisk Foundation. CARB-X also receives in-kind support from the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH). [11]

In its first five years, from 2016 to 2021, CARB-X awarded $361 million to 92 projects. [12] In 2022, BARDA and Wellcome renewed committed renewed funding up to an additional $370 million to CARB-X. [13] In 2023, the German and UK governments renewed funding to CARB-X, committing an additional €41 million [14] and £24 million; [15] the government of Canada committed CAD$6.3 million over two years; and The Novo Nordisk Foundation committed USD$25 million over three years.

In addition to awarding non-dilutive funding, CARB-X partners with a Global Accelerator Network (GAN) of experts who offer product developers advice on a range of issues, including drug development, business strategy, policy and regulatory affairs. [16]

At the 2024 G7 Joint Finance and Health Ministers’ Meeting, Italy announced a $21 million investment in CARB-X, a partnership that funds early-stage antibiotic research. [17] This funding aims to accelerate the development of new products for preventing, diagnosing, and treating drug-resistant infections. Italy joins five other G7 governments and major global health foundations, and CARB-X has already supported 104 R&D projects globally, with 18 advancing to clinical trials and some reaching the market.

Global Recognition

The G7 Health Ministers have cited CARB-X [18] among the critical initiatives to support as the G7 governments renew their 2021 commitment to address the most dangerous drug-resistant infections. In May 2023, the global threat of Antimicrobial Resistance and the importance of supporting CARB-X as a global push incentive that coordinates and accelerates much-needed antibacterial innovation was featured in G7 Hiroshima Leaders’ Communiqué [19] and the G7 Nagasaki Health Ministers’ Communiqué. [20] The same year, G20 Health Ministers cited CARB-X as playing a critical role in accelerating antimicrobial R&D and access. [21] In October 2024, the importance of supporting CARB-X as a global push incentive that accelerates the research and development of antibacterial products was featured in G7 Health Ministers' Communiqué.< [22]

In May 2024, the Antimicrobial Resistance (AMR) Multi-Stakeholder Partnership Platform issued a call for actionable steps to address the rising threat of AMR ahead of the United Nations General Assembly High-Level Meeting on AMR in September 2024. The call recommended increasing public investment in push incentives to catalyze global antimicrobial R&D efforts and cited CARB-X as a push mechanism that should be mobilized due to CARB-X’s critical role in supporting the discovery and development or new antimicrobials. [23]  

CARB-X also was named in the Political Declaration on antimicrobial resistance (AMR) approved by United Nations Member States during the High-Level Meeting on September 26, 2024 at the 79th Session of the UN General Assembly. “The research and development pipeline for vaccines, diagnostics, therapeutics, especially antimicrobials and alternatives to the use of antimicrobials, to prevent and address antimicrobial resistance, especially antibiotics, are insufficient,” UN Member States note with concern in the declaration. As a consequence, they openly “recognize the benefits of public-private partnerships in the development of and access to antimicrobials, vaccines, diagnostics and alternatives to antimicrobials and in contributing to supply chain sustainability, and take note of the work of the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) and the Global Antibiotic Research and Development Partnership (GARDP).” [24]

Related Research Articles

<span class="mw-page-title-main">Antibiotic</span> Antimicrobial substance active against bacteria

An antibiotic is a type of antimicrobial substance active against bacteria. It is the most important type of antibacterial agent for fighting bacterial infections, and antibiotic medications are widely used in the treatment and prevention of such infections. They may either kill or inhibit the growth of bacteria. A limited number of antibiotics also possess antiprotozoal activity. Antibiotics are not effective against viruses such as the ones which cause the common cold or influenza. Drugs which inhibit growth of viruses are termed antiviral drugs or antivirals. Antibiotics are also not effective against fungi. Drugs which inhibit growth of fungi are called antifungal drugs.

<span class="mw-page-title-main">Antimicrobial resistance</span> Resistance of microbes to drugs directed against them

Antimicrobial resistance occurs when microbes evolve mechanisms that protect them from the effects of antimicrobials. All classes of microbes can evolve resistance to the point that one or more drugs used to fight them are no longer effective. Fungi evolve antifungal resistance, viruses evolve antiviral resistance, protozoa evolve antiprotozoal resistance, and bacteria evolve antibiotic resistance. Together all of these come under the umbrella of antimicrobial resistance.

<i>Klebsiella pneumoniae</i> Species of bacterium

Klebsiella pneumoniae is a Gram-negative, non-motile, encapsulated, lactose-fermenting, facultative anaerobic, rod-shaped bacterium. It appears as a mucoid lactose fermenter on MacConkey agar.

An antimicrobial is an agent that kills microorganisms (microbicide) or stops their growth. Antimicrobial medicines can be grouped according to the microorganisms they act primarily against. For example, antibiotics are used against bacteria, and antifungals are used against fungi. They can also be classified according to their function. The use of antimicrobial medicines to treat infection is known as antimicrobial chemotherapy, while the use of antimicrobial medicines to prevent infection is known as antimicrobial prophylaxis.

Multiple drug resistance (MDR), multidrug resistance or multiresistance is antimicrobial resistance shown by a species of microorganism to at least one antimicrobial drug in three or more antimicrobial categories. Antimicrobial categories are classifications of antimicrobial agents based on their mode of action and specific to target organisms. The MDR types most threatening to public health are MDR bacteria that resist multiple antibiotics; other types include MDR viruses, parasites.

<span class="mw-page-title-main">Global health</span> Health of populations in a global context

Global health is the health of populations in a worldwide context; it has been defined as "the area of study, research, and practice that places a priority on improving health and achieving equity in health for all people worldwide". Problems that transcend national borders or have a global political and economic impact are often emphasized. Thus, global health is about worldwide health improvement, reduction of disparities, and protection against global threats that disregard national borders, including the most common causes of human death and years of life lost from a global perspective.

<span class="mw-page-title-main">Health in Thailand</span>

Thailand has had "a long and successful history of health development," according to the World Health Organization. Life expectancy is averaged at seventy years. Non-communicable diseases form the major burden of morbidity and mortality, while infectious diseases including malaria and tuberculosis, as well as traffic accidents, are also important public health issues.

<span class="mw-page-title-main">One Health Trust</span> Public health research organization

One Health Trust, formerly the Center for Disease Dynamics, Economics & Policy, is a public health research organization with offices in Washington, D.C., New Delhi, and Bangalore, India.

<span class="mw-page-title-main">Antibiotic use in livestock</span> Use of antibiotics for any purpose in the husbandry of livestock

Antibiotic use in livestock is the use of antibiotics for any purpose in the husbandry of livestock, which includes treatment when ill (therapeutic), treatment of a group of animals when at least one is diagnosed with clinical infection (metaphylaxis), and preventative treatment (prophylaxis). Antibiotics are an important tool to treat animal as well as human disease, safeguard animal health and welfare, and support food safety. However, used irresponsibly, this may lead to antibiotic resistance which may impact human, animal and environmental health.

<span class="mw-page-title-main">British Society for Antimicrobial Chemotherapy</span> British-based academic scientific society

The British Society for Antimicrobial Chemotherapy (BSAC) is a UK-based multi-professional organisation committed to preventing infectious diseases and tackling the growing threat of drug-resistant infections – one of the one of the top global public health and development threats.

The Community for Open Antimicrobial Drug Discovery (CO-ADD) is a not-for-profit initiative created in 2015 reaching out to chemists in academia and research organisations who have compounds that were not designed as antibiotics and would not otherwise be screened for antimicrobial activity. These academic compounds are screened against a key panel of drug-resistant bacterial strains -superbugs. Multi-drug resistant microbes are a serious health treat, and exploration of novel chemical diversity is essential to find new antibiotics.

Kevin Outterson is a lawyer, a professor of law and the Austin B. Fletcher Professor Boston University School of Law (2023-present). He is also the executive director of Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator, a global non-profit partnership that supports companies developing new antibiotics, diagnostics, vaccines and other products to address drug-resistant bacterial infections.

ESKAPE is an acronym comprising the scientific names of six highly virulent and antibiotic resistant bacterial pathogens including: Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter spp. The acronym is sometimes extended to ESKAPEE to include Escherichia coli. This group of Gram-positive and Gram-negative bacteria can evade or 'escape' commonly used antibiotics due to their increasing multi-drug resistance (MDR). As a result, throughout the world, they are the major cause of life-threatening nosocomial or hospital-acquired infections in immunocompromised and critically ill patients who are most at risk. P. aeruginosa and S. aureus are some of the most ubiquitous pathogens in biofilms found in healthcare. P. aeruginosa is a Gram-negative, rod-shaped bacterium, commonly found in the gut flora, soil, and water that can be spread directly or indirectly to patients in healthcare settings. The pathogen can also be spread in other locations through contamination, including surfaces, equipment, and hands. The opportunistic pathogen can cause hospitalized patients to have infections in the lungs, blood, urinary tract, and in other body regions after surgery. S. aureus is a Gram-positive, cocci-shaped bacterium, residing in the environment and on the skin and nose of many healthy individuals. The bacterium can cause skin and bone infections, pneumonia, and other types of potentially serious infections if it enters the body. S. aureus has also gained resistance to many antibiotic treatments, making healing difficult. Because of natural and unnatural selective pressures and factors, antibiotic resistance in bacteria usually emerges through genetic mutation or acquires antibiotic-resistant genes (ARGs) through horizontal gene transfer - a genetic exchange process by which antibiotic resistance can spread.

Antimicrobial resistance (AMR) directly kills about 1,600 people each year in Australia. This is a currently serious threat to both humans and animals in the country. Antimicrobial resistance occurs when a microorganism evolves and gains the ability to become more resistant or completely resistant to the medicine that was previously used to treat it. Drug-resistant bacteria are increasingly difficult to treat, requiring replacement or higher-dose drugs that may be more expensive or more toxic. Resistance can develop through one of the three mechanisms: natural resistant ability in some types of microorganisms, a mutation in genes or receiving the resistance from another species. Antibodies appear naturally due to random mutations, or more often after gradual accumulation over time, and because of abuse of antibiotics. Multidrug-resistance, or MDR, are the microorganisms that are resistant to many types of antimicrobials. "Superbugs" is the term also used for multidrug-resistant microbes, or totally drug-resistant (TDR).

The Society of Infectious Diseases Pharmacists (SIDP) is a non-profit organization comprising pharmacists and other allied health professionals specializing in infectious diseases and antimicrobial stewardship. According to the Board of Pharmaceutical Specialties, clinical pharmacists specializing in infectious diseases are trained in microbiology and pharmacology to develop, implement, and monitor drug regimens. These regimens incorporate the pharmacodynamics and pharmacokinetics of antimicrobials for patients.

Alison Helen Holmes is a British infectious diseases specialist, who is a professor at Imperial College London and the University of Liverpool. Holmes serves as Director of the National Institute for Health Research (NIHR) Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance and Consultant at Hammersmith Hospital. Holmes is on the Executive Committee of the International Society of Infectious Diseases, and she serves on a variety of World Health Organization (WHO) expert groups related to antimicrobial use, Antimicrobial Resistance (AMR), infection prevention and sepsis. Her research considers how to mitigate antimicrobial resistance.

The Centre for Genomic Pathogen Surveillance is a computational genomics research institute in Oxfordshire.

The Global Leaders Group on Antimicrobial Resistance consists of world leaders and experts from across sectors working together to accelerate political action on antimicrobial resistance (AMR).

<span class="mw-page-title-main">Fabimycin</span> Antibiotic

Fabimycin is an newly developed antibiotic candidate which is effective against gram-negative bacterias, an unusually problematic class of bacteria that uses thicker cell walls and molecular efflux pumps to protect themselves by preventing the antibiotics reaching inside the cells.

<span class="mw-page-title-main">Cresomycin</span> Chemical compound

Cresomycin is an experimental antibiotic. It binds to the bacterial ribosome in both Gram-negative and Gram-positive bacteria, and it has been found to be effective against multi-drug-resistant stains of Staphylococcus aureus, Escherichia coli, and Pseudomonas aeruginosa. It belongs to the bridged macrobicyclic oxepanoprolinamide antibiotics, which have similarities with lincosamides antibiotics.

References

  1. ↑ "Overview". Carb-X. Retrieved 2022-01-14.
  2. ↑ "CARB-X Global Partnership". Boston University . Archived from the original on 2016-08-02. Retrieved 2021-06-18.
  3. ↑ CDC (2021-11-22). "How do germs become resistant?". Centers for Disease Control and Prevention. Retrieved 2022-01-14.
  4. ↑ "Wellcome Trust Report: "How is modern medicine being affected by drug-resistant infections?"" (PDF). Archived (PDF) from the original on 2021-10-29.
  5. ↑ "Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis".
  6. ↑ "Overview". Carb-X. Retrieved 2022-01-14.
  7. ↑ "WHO Priority List of Antibiotic Resistant Bacteria" (PDF). Archived (PDF) from the original on 2017-02-27.
  8. ↑ CDC (2021-11-23). "The biggest antibiotic-resistant threats in the U.S." Centers for Disease Control and Prevention. Retrieved 2022-01-14.
  9. ↑ "Why is it so hard to develop new antibiotics?". Wellcome. Retrieved 2022-01-14.
  10. ↑ Jacobs, Andrew (2019-12-25). "Crisis Looms in Antibiotics as Drug Makers Go Bankrupt". The New York Times. ISSN   0362-4331 . Retrieved 2022-01-14.
  11. ↑ "Overview". Carb-X. Retrieved 2022-01-14.
  12. ↑ "2020-2021 CARB-X Annual Report" (PDF). Archived (PDF) from the original on 2021-10-12.
  13. ↑ "U.S. government and Wellcome commit up to an additional US$370 million to CARB-X". Carb-X. Retrieved 2022-08-24.
  14. ↑ "GERMAN GOVERNMENT RENEWS COMMITMENT TO CARB-X".
  15. ↑ "UK GOVERNMENT BOLSTERS PARTNERSHIP WITH CARB-X".
  16. ↑ "Accelerators / Other Partners". Carb-X. Retrieved 2022-01-14.
  17. ↑ "Documents of the Health Ministers' Meeting in Ancona | G7 Italia". G7 Italia 2024. Retrieved 2024-10-18.
  18. ↑ "G7 Health Ministers' Communiqué" (PDF). G7 Germany. May 20, 2022.
  19. ↑ G7 Hiroshima Leaders’ Communiqué (PDF). G7 Japan. May 20, 2023
  20. ↑ G7 Nagasaki Health Ministers’ Communiqué (PDF). G7 Japan. May 13, 2023.
  21. ↑ G20 Health Ministers' Outcome Document (PDF). G20 India. August 19, 2023.
  22. ↑ "G7 Health Ministers' Communiqué" (PDF). G7 Italy. Retrieved 18 October 2024.
  23. ↑ Call for actionable steps in response to the rising threat of antimicrobial resistance (AMR) Antimicrobial Resistance (AMR) Multi-Stakeholder Partnership Platform. May 2024.
  24. ↑ Political Declaration of the High-level Meeting on Antimicrobial Resistance. September 2024


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