WHO 2020 preclinical antibacterial pipeline data call open

30 April 2020

Companies, institutions and individuals are invited to submit data on their products that are in the preclinical pipeline that fulfil the below inclusion criteria. Data submitted should be non-confidential and will be made available publicly on the WHO Global Health R&D Observatory.


Submit your data here
User name: antibacterial-pipeline
Password: antibacterial-p


Background

In January 2020, WHO released its first global review of the preclinical antibacterial pipeline. The review captured 252 antibacterial products that are being developed in 145 institutions around the world. These products target WHO priority pathogens, Mycobacterium tuberculosis or Clostridioides difficile. This is the first comprehensive overview of the preclinical antibacterial pipeline to date that is based on publicly available data primarily gathered through a WHO data call. The review identified a broad geographic distribution and diversity of projects. Overall the preclinical pipeline suggests that the ecosystem is relatively innovative (e.g. many projects pursue non-traditional approaches, particularly phages and antimicrobial peptides), though the size of the preclinical pipeline is likely insufficient to adequately generate the therapeutics needed to ensure availability of effective antibacterials. WHO will update this overview on an annual basis. This data call is for the 2020 update of the preclinical antibacterial pipeline review.

We would like to sincerely thank all respondents of the first WHO data call and encourage their continued participation, without which this review would not be possible.

The 2019 preclinical data is available on the open source WHO Global Health R&D Observatory, and published in the WHO report Antibacterial agents in preclinical development: an open access database. We invite all interested parties to access this interactive database via the link below. The 2020 update will feed into the WHO Global Health R&D Observatory and shared with multiple stakeholders including existing and future funders of R&D. Link to the WHO Global Health R&D Observatory: (https://www.who.int/research-observatory/monitoring/processes/antibacterial_products_preclinical/en

Definition of ‘preclinical’ for this analysis

For this review, preclinical products include 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 a sufficient 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.

* If in a given program, 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 Analysis

Products that are active against WHO 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)
  • Antivirulence agents and biofilm disruptors
  • Potentiators or enablers that improve activity of existing products (e.g. resistance modulating agents, BLIs, penetration enablers, efflux inhibitors)
  • Large molecules (natural products, e.g. antimicrobial peptides, biologics, e.g. antibodies, bacteriophages and bacteriophage derived products)
  • Microbiome modifying agents
  • Immunomodulators
  • Repurposed non-antibiotics
  • Repurposed from animal to human use antibiotics
  • De-colonisation agents
  • Combination therapies

New for 2020 update: Vaccines and other preventative agents to prevent infection or bacterial transmission

Exclusion Criteria

Products excluded from this analysis are diagnostics, antifungals, antivirals and antiparasitics as they are covered through other WHO programmes. In addition, wound care products, unspecific supportive treatments, 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.

If you have any questions please email: [email protected].