Multi-year analysis of the global preclinical antibacterial pipeline: trends and gaps

Author:

Gigante Valeria1ORCID,Alm Richard A.23ORCID,Melchiorri Daniela4,Rocke Tamarie3,Arias Cesar A.5ORCID,Czaplewski Lloyd6,Fernandes Prabhavathi7,Franceschi François8,Harbarth Stephan910,Kozlov Roman11,Lienhardt Christian12,Ohmagari Norio13,Ogilvie Lesley A.14,Paul Mical1516,Rex John H.17181920,Silver Lynn L.21ORCID,Spigelman Melvin22,Sati Hatim1,Cameron Alexandra M.1

Affiliation:

1. AMR Division, World Health Organization, Geneva, Switzerland

2. Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, Boston, Massachusetts, USA

3. WHO Consultants to the WHO AMR Division, Geneva, Switzerland

4. Department of Physiology and Pharmacology, Sapienza University, Rome, Italy

5. Center for Infectious Diseases Research, Houston Methodist Research Institute, Houston, Texas, USA

6. Chemical Biology Ventures Ltd., Abingdon, United Kingdom

7. National Biodefense Science Board, U.S. Department of Health and Human Services, Washington, DC, USA

8. Global Antibiotic Research & Development Partnership, Geneva, Switzerland

9. Infection Control Programme, Geneva University Hospitals, Geneva, Switzerland

10. Faculty of Medicine, WHO Collaborating Center for Patient Safety, Geneva, Switzerland

11. Institute of Antimicrobial Chemotherapy, Smolensk State Medical University, Smolensk, Russia

12. Université de Montpellier, INSERM, Institut de Recherche pour le Développement, Montpellier, France

13. National Center for Global Health and Medicine, Tokyo, Japan

14. Global Antimicrobial Resistance Research and Development Hub, Berlin, Germany

15. Infectious Diseases, Rambam Health Care Campus, Haifa, Israel

16. The Ruth and Bruce Rappaport Faculty of Medicine, Technion Israel Institute of Technology, Haifa, Israel

17. F2G, Limited, Eccles, United Kingdom

18. AMR Solutions, Boston, Massachusetts, USA

19. Advent Life Sciences, London, United Kingdom

20. McGovern Medical School, The University of Health Science Center at Houston, Houston, Texas, USA

21. LL Silver Consulting, Springfield, New Jersey, USA

22. Global Alliance for TB Drug Development, New York, New York, USA

Abstract

ABSTRACT Antimicrobial resistance (AMR) is a major global health threat estimated to have caused the deaths of 1.27 million people in 2019, which is more than HIV/AIDS and malaria deaths combined. AMR also has significant consequences on the global economy. If not properly addressed, AMR could immensely impact the world’s economy, further increasing the poverty burden in low- and middle-income countries. To mitigate the risk of a post-antibiotic society, where the ability to effectively treat common bacterial infections is being severely threatened, it is necessary to establish a continuous supply of new and novel antibacterial medicines. However, there are gaps in the current pipeline that will prove difficult to address, given the time required to develop new agents. To understand the status of upstream antibiotic development and the challenges faced by drug developers in the early development stage, the World Health Organization has regularly assessed the preclinical and clinical antibacterial development pipeline. The review identifies potential new classes of antibiotics or novel mechanisms of action that can better address resistant bacterial strains. This proactive approach is necessary to stay ahead of evolving resistance patterns and to support the availability of effective treatment options. This review examines the trends in preclinical development and attempts to identify gaps and potential opportunities to overcome the numerous hurdles in the early stages of the antibacterial research and development space.

Funder

European Commission

Publisher

American Society for Microbiology

Reference22 articles.

1. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis

2. The World Bank. 2017. Drug-resistant infections: a threat to our economic future. The World Bank/Topics/Health Geneva Switzerland. Available from: https://www.worldbank.org/en/topic/health/publication/drug-resistant-infections-a-threat-to-our-economic-future. Retrieved 26 Mar 2024.

3. OECD Publishing. 2023. Embracing a one health framework to fight antimicrobial resistance. OECD Health Policy Studies Paris France. Available from: https://doi.org/10.1787/ce44c755-en. Retrieved 26 Mar 2024.

4. World Health Organization. 2019. Ten threats to global health in 2019. WHO/Health topics Geneva Switzerland. Available from: https://www.who.int/news-room/spotlight/tenthreats-to-global-health-in-2019. Retrieved 26 Mar 2024.

5. World health organization. 2024. In 2023 Antibacterial agents in clinical and preclinical developmentand. Geneva, Switzerland.

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