WHO 2020 preclinical antibacterial pipeline data call open

  02 May 2020

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

Further reading: WHO
Author(s): WHO
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