Introduction
To have a robust clinical antifungal pipeline it's essential to invest and monitor its upstream development.
In November 2022 WHO released the WHO fungal priority pathogens list (FPPL), a catalogue of the 19 fungi that represent the greatest threat to public health. The list is the first global effort to systematically prioritize fungal pathogens, considering the unmet research and development (R&D) needs and the perceived public health importance. To evaluate the global preparedness against fungal infections and antifungal resistance, WHO is reviewing the antifungal clinical and preclinical pipeline and is inviting developers to share information on their preclinical research projects.
The objective is to strengthen the global response towards invasive fungal diseases, by driving R&D efforts, interest and funding opportunities towards the highest unmet medical needs.
WHO 2024 data call for antifungal agents in preclinical development pipeline
WHO 2024 data call aims to collect data on antifungal agents in the preclinical development pipeline using the survey link below.
The 2024 preclinical data analyses will feed into the WHO antifungal pipeline analysis and data will be available for all stakeholders including existing and future funders of R&D, through the WHO Global Health R&D Observatory.
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 for WHO analysis of antifungal agents in preclinical development
Products that are administered systemically or locally and are active against invasive infections due to the fungal pathogens on the WHO FPPL, 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 WHO analysis of antifungal agents in preclinical development
Products excluded from this analysis are diagnostics, antivirals and antiparasitic agents as they are covered through other WHO initiatives. Antibacterial agents in preclinical development are excluded as they will be covered by a separate data call that will be available on this website in the upcoming months.
Additional exclusions include wound care products, unspecific supportive treatments, products targeting fungi beyond the scope of the WHO FPPL, topical or locally administered products targeting mild skin or local infections, and medical devices. Products for 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 through the WHO antifungal pipeline analysis and the WHO Global Health R&D Observatory.