Article published on September 29, 2021, on the World Health Organization website
Opening date: 30 September 2021 at 12:00 Geneva time
Closing date: 30 October 2021 at 23:30 Geneva time
Introduction
In January 2019 and 2020, the World Health Organization (WHO) released its first performed global reviews of the preclinical antibacterial pipeline, based on publicly available data primarily gathered through a WHO data call.
A 2020 update of the antibacterial preclinical data analyses report was performed and is available on the open source WHO Global Health R&D Observatory, and was published in the WHO Report 2020 antibacterial agents in clinical and preclinical development: an overview and analysis.
WHO 2021 data call for antibacterial, and antifungal agents in preclinical development pipeline
WHO 2021 data call aims to collect data on:
- The 2021 update of WHO analysis and review antibacterial agents in the preclinical development pipeline.
- The first WHO analysis of antifungal agents in the preclinical development pipeline.
The 2021 preclinical data analyses will feed into the WHO Global Health R&D Observatory. The analyses and data will be available for all stakeholders including existing and future funders of R&D.
We would like to thank those who have responded to previous WHO data calls and encourage their and others continued participation, without which this review would not be possible.
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 of regulatory authorities to begin human clinical testing.
*Note:For any given program, if a medicinal chemistry backup program is ongoing in parallel with the 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, or C. difficile 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 or biologics like for example 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
Exclusion criteria (for antibacterial agents in preclinical development)
Products excluded from this analysis are diagnostics, antivirals and antiparasitics as they are covered through other WHO programmes. Antifungals are also excluded form and are covered by a separate data collection form (Please see at the end of this page the form links).
In addition, wound care products, unspecific supportive treatments, topical or locally administered products targeting mild skin or local infections, products targeting bacteria beyond the scope of the WHO priority pathogens list, M. tuberculosis and C. difficile, medical devices, industrial or animal use are also not included.
Inclusion criteria and scope of WHO analysis for antifungal agents in preclinical development
Products that are administered systemically or locally and are active against invasive infections due to selected fungal pathogens (pathogens and indications are included in the survey form), including:
- Small molecule – direct acting
- Small molecule – indirect acting
- Peptide – direct acting
- Peptide – indirect acting
- Large molecule – direct acting
- Large molecule – indirect acting
- Antibody-drug conjugate (ADC)
- Biologic (Antibody or other biotherapeutics)
- Immunomodulators
- Others
Exclusion criteria (for antifungals agents in preclinical development):
Products excluded from this analysis are diagnostics, antivirals and antiparasitic agents as they are covered through other WHO programs. Antibacterial agents in preclinical development are excluded as they’re covered by a separate data collection form (please see at the end of this page the form links).
In addition, excluded are wound care products, unspecific supportive treatments, products targeting fungi beyond the scope of the review (as outlined in the data collection form), topical or locally administered products targeting mild skin or local infections, medical devices, industrial or animal use are also not included.
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.
Data collection form links:
WHO 2021 survey on antibacterial agents in the preclinical development pipeline
WHO 2021 survey on antifungal agents in the preclinical development pipeline