US Food and Drug Administration, Centers for Disease Control and Prevention, and National Institutes of Health Co-Sponsored Public Workshop Summary—Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea-Reference-Cited by-同舟云学术

US Food and Drug Administration, Centers for Disease Control and Prevention, and National Institutes of Health Co-Sponsored Public Workshop Summary—Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea

Published:2024-07-24 Issue: Volume: Page:
ISSN:1058-4838
Container-title:Clinical Infectious Diseases
language:en
Short-container-title:

Author:

Hiruy Hiwot¹,Bala Shukal¹,Byrne James M²,Roche Kerian Grande¹,Jang Seong H³,Kim Peter¹,Nambiar Sumathi¹,Rubin Dan⁴,Yasinskaya Yuliya¹,Bachmann Laura H⁵,Bernstein Kyle⁶,Botgros Radu⁷,Cammarata Sue⁸,Chaves Ricardo L⁹,Deal Carolyn D¹⁰,Drusano George L¹¹,Duffy Erin M¹²,Eakin Ann E¹³,Gelone Steve¹⁴,Hiltke Thomas¹⁵,Hook Edward W¹⁶,Jerse Ann E¹⁷,McNeil Candice J¹⁸,Newman Lori¹⁹,O’Brien Seamus²⁰,Perry Caroline²¹,Reno Hilary E L²²,Romaguera Raul A⁶,Sato Junko²³,Unemo Magnus²⁴,Wi Teodora E C²⁵,Workowski Kimberly²⁶,O’May Graeme A²⁷,Shukla Sunita J²,Farley John J²

Affiliation:

1. Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring , Maryland , USA

2. Office of Infectious Diseases, Office of New Drugs, CDER, FDA , Silver Spring, Maryland , USA

3. Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA , Silver Spring, Maryland , USA

4. Division of Biometrics IV, Office of Biostatistics, Office of Translational Sciences, CDER, FDA , Silver Spring, Maryland , USA

5. Division of STD Prevention, National Center for HIV/AIDs, Viral Hepatitis, STD and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC) , Atlanta, Georgia , USA

6. Division of STD Prevention, NCHHSTP, CDC , Atlanta, Georgia , USA

7. Office of Biological Health Threats and Vaccines Strategy, Clinical Studies and Manufacturing Task Force, European Medicines Agency , Amsterdam , The Netherlands

8. Department of Clinical Development, Melinta Therapeutics , Parsippany, New Jersey , USA

9. Department of Clinical Development, Debiopharm International SA , Lausanne , Switzerland

10. Enteric and Sexually Transmitted Infections Branch, Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) , Bethesda, Maryland , USA

11. Institute for Therapeutic Innovation, College of Medicine, University of Florida , Lake Nona, Florida , USA

12. Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), Boston University , Boston, Massachusetts , USA

13. Office of Biodefense, Research Resources & Translational Research, DMID, NIAID, NIH , Bethesda, Maryland , USA

14. Office of the President - Clinical Research and Development, Nabriva Therapeutics plc , Fort Washington, Pennsylvania , USA

15. Enteric and Sexually Transmitted Infections Branch, DMID, NIAID, NIH , Bethesda, Maryland , USA

16. Department of Medicine, University of Alabama at Birmingham , Birmingham, Alabama , USA

17. Department of Microbiology and Immunology, Uniformed Services University , Bethesda, Maryland , USA

18. Department of Medicine, Section on Infectious Diseases, Wake Forest University School of Medicine, Southeast STD/HIV PTC, Forsyth County Department of Public Health, and North Carolina Strengthening the United States Response to Resistant Gonorrhea , Winston-Salem, North Carolina , USA

19. Enteric and Sexually Transmitted Infections Branch, DMID, NIAID, NIH , Rockville, Maryland , USA

20. - Research and Development, Global Antibiotic Research & Development Partnership Director , Geneva , Switzerland

21. Department of Clinical Research and Early Programs, GlaxoSmithKline , Collegeville, Pennsylvania , USA

22. Washington University School of Medicine in St. Louis, St. Louis STD/HIV Prevention Training Center, St. Louis STI Regional Response Coalition , St. Louis, Missouri , USA

23. Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA) , Tokyo , Japan

24. World Health Organization (WHO) Collaborating Centre for Gonorrhea and Other STIs, Örebro University , Örebro , Sweden

25. Global HIV, Hepatitis and STIs Programmes, WHO , Geneva , Switzerland

26. Department of Medicine, Emory University , Atlanta, Georgia , USA

27. DRT Strategies, Inc , Arlington, Virginia , USA

Abstract

Abstract There is an unmet need for developing drugs for the treatment of gonorrhea due to rapidly evolving resistance of Neisseria gonorrhoeae against antimicrobial drugs used for empiric therapy, an increase in globally reported multidrug-resistant cases, and the limited available therapeutic options. Furthermore, few drugs are under development. Development of antimicrobials is hampered by challenges in clinical trial design, limitations of available diagnostics, changes in and varying standards of care, lack of robust animal models, and clinically relevant pharmacodynamic targets. On 23 April 2021, the US Food and Drug Administration, Centers for Disease Control and Prevention, and National Institute of Allergy and Infectious Diseases of the National Institutes of Health co-sponsored a workshop with stakeholders from academia, industry, and regulatory agencies to discuss the challenges and strategies, including potential collaborations and incentives, to facilitate the development of drugs for the treatment of gonorrhea. This article provides a summary of that workshop.

Funder

Center for Drug Evaluation and Research

US FDA

CARB-X

US Department of Health and Human Services

Administration for Strategic Preparedness and Response

Biomedical Advanced Research and Development Authority

Wellcome Trust

Federal Ministry of Education and Research

BMBF

Federal Republic of Germany

Publisher