Developers of traditional and nontraditional agents intended against pathogens on the WHO BPPL and against other medically important pathogens are encouraged to submit their data
Introduction
In January 2020 WHO published its first global analyses of the preclinical antibacterial pipeline, based on publicly available data. The data were primarily gathered through an open data call, with planned annual updates.
The antibacterial pre-clinical pipeline was reviewed again in 2021, and the updates were published in 2022. The updated data are available on the open source WHO Global Health R&D Observatory, and the full updated analyses was also published in the WHO report entitled: 2021 antibacterial agents in clinical and preclinical development: an overview and analysis.
WHO 2023 data call for antibacterial agents in preclinical development pipeline aims to collect data on traditional and non-traditional antibacterial agents candidates intended against the WHO bacterial priority pathogens (WHO BPPL) and other antibacterial resistant pathogens of public health importance.
This year WHO is collecting information on antimicrobials relevant for AMR including other medically important resistant pathogens, that are not included in the 2017 WHO BPPL.
The 2023 preclinical data updates and analyses will feed into the open WHO source Global Health R&D Observatory and will be available for all stakeholders.
We would like to thank those who have responded to previous WHO data calls and encourage your participation in this year’s data call.
Scope and definitions
For this data call/review, the term “preclinical products” refers to all products* from lead-optimization (post hit expansion), preclinical candidate, to formal CTA/IND enabling studies prior to the commencement of human testing.
- Lead optimization: iterative in vitro and in vivo screens of lead compounds to generate suitable pharmacological, safety and pharmacokinetic profiles of one or more candidates to progress into preclinical development.
- Preclinical candidate: a lead compound, or a shortlist of compounds that are being actively compared, that have been evaluated in initial toxicology tests and demonstrates the required safety profile which when combined with a suitable understanding of pharmacological efficacy warrants advancement.
- CTA/IND-enabling studies: studies including detailed ADME (absorption, distribution, metabolism, and excretion) studies and GLP (good laboratory practice) toxicology, as well as formulation and manufacturing development necessary to obtain the permission from regulatory authorities to begin human clinical testing.
* Note: For any given program, if a medicinal chemistry backup program is ongoing in parallel with advancement of a lead compound(s) in the same chemical series then the development phase of the most advanced compound being actively studied should be recorded. Inclusion criteria and scope of WHO analysis for antibacterial agents in preclinical development
Products that are active against WHO bacterial priority pathogens, M. tuberculosis, C. difficile or other medically important bacterial pathogens should be included in the preclinical pipeline analysis. These include:
- Directly and indirectly acting small molecule antibacterial agents (including antimycobacterial drugs)
- Anti-virulence agents and biofilm disruptors
- Potentiators or enablers that improve activity of existing products (e.g., resistance modulating agents, BLI, penetration enablers, efflux inhibitors)
- Large molecules (natural products, e.g., antimicrobial peptides, biologics, e.g., antibodies, bacteriophages and bacteriophages derived products)
- Microbiome modifying agents
- Immunomodulators
- Repurposed non-antibiotics
- Repurposed from animal to human use antibiotics
- De-colonization agents
- Combination therapies
Companies, institutions, and individuals are invited to submit data on their products that are in the preclinical pipeline that fulfil the above inclusion criteria. Data submitted should be non-confidential and will be made available publicly on the WHO Global Health R&D Observatory.
Exclusion criteria (for antibacterial agents in preclinical development)
Products excluded from this analysis are diagnostics, vaccines, antivirals, antiparasitics and antifungals as they are covered through other WHO programmes/publications.
In addition, wound care products, unspecific supportive treatments, topical or locally administered products targeting mild skin or local infections, medical devices, industrial or animal use are also not included.
WHO 2023 survey on antibacterial agents in the preclinical developmental pipeline.
Opening date: 6 March 2023 at 12:00 Geneva time
Closing date: 17 April 2023 at 23:30 Geneva time
