On the verge of a post-antibiotic reality, there is an urgent clinical need for new antibiotics. Luckily, new candidates are in the pipeline and older agents are getting a second breath of life through combination therapy. 

In this episode of Communicable, host Erin McCreary invites Dr. Markus Zeitlinger of the University of Vienna (Austria) and scientific expert for the European Medicines Agency (EMA) and Dr. Michael Dudley, president and CEO of Qpex Biopharma, to discuss antimicrobials in the clinical development pipeline.  Together they unpack how the WHO curate the priority list of pathogens and how companies adapt such lists into their antimicrobial development business plans. They also discuss the unique challenges and complexities of developing antibiotics, from return on investments and defining the ‘novelty’ of an agent to the conundrum of balancing post-market approval and antimicrobial stewardship. Beta-lactamase inhibitors and oral carbapenems in the pipeline targeting ‘the big three’ (Enterobacterales, Pseudomonas and Acinetobacter) are the primary focus.

This episode was edited by Kathryn Hostettler and peer-reviewed by Dr. Benjamin Berinson of the Medical Centre Hamburg-Eppendorf (UKE), Germany. For more information on the WHO Priority Pathogens List and its 2024 update, check out our previous episode, Communicable E3 (see Literature). 

Literature 

Communicable E3 - The New WHO Priority Pathogens List: which bugs to target first? 17 June 2024. https://communicable.transistor.fm/episodes/communicable-e3-the-new-who-priority-pathogens-list-which-bacteria-to-target-first 

WHO Bacterial Priority Pathogens List, 2024: bacterial pathogens of public health importance to guide research, development and strategies to prevent and control antimicrobial resistance. Geneva: World Health Organization; 17 May 2024. https://www.who.int/publications/i/item/9789240093461 

C. Le Terrier et al, NDM-9 resistance to taniborbactam. Lancet Infect Dis 23, 401-402 (2023). doi 10.1016/S1473-3099(23)00069-5     

P. B. Eckburg et al, Oral Tebipenem Pivoxil Hydrobromide in Complicated Urinary Tract Infection. N Engl J Med 386, 1327-1338 (2022). doi: 10.1056/NEJMoa2105462 

A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) (PIVOT-PO). https://clinicaltrials.gov/study/NCT06059846

Meiji Seika Pharma Initiated the Global Phase III Clinical Trials of OP0595, a Novel beta-Lactamase Inhibitor for Combatting Antimicrobial Resistance (AMR). Tokyo: Meiji Seika Pharma Ltd; 26 April 2023. https://www.meiji.com/global/news/2023/pdf/230426_01.pdf