[Ip-health] WHO 2018 Update of Antibacterial agents in clinical development an analysis of the antibacterial clinical development pipeline, including tuberculosis

PAULIN, Sarah paulins at who.int
Wed Oct 24 08:22:44 PDT 2018


WHO has updated its clinical antibacterial pipeline analysis and published both a WHO publication and a Lancet ID publication.

WHO publication: 2018 Update of Antibacterial agents in clinical development an analysis of the antibacterial clinical development pipeline, including tuberculosis

  *   Link: http://apps.who.int/iris/bitstream/handle/10665/275487/WHO-EMP-IAU-2018.06-eng.pdf

Key messages:
As of 1 July 2018, a total of 48 antibiotics (including combinations) and 10 biologicals that target the WHO priority pathogens, Mycobacterium tuberculosis and Clostridium difficile were in the pipeline. The biggest gap and need is for innovative antibacterials to treat the priority pathogens, in particular critical Gram-negative bacteria. The antibacterial agents in the pipeline are the following:
■ 38 new therapeutic entities (30 antibiotics and 8 biologicals) and 4 combinations targeting priority pathogens.
■ 10 agents targeting Mycobacterium tuberculosis.
■ 6 agents (4 antibiotics and 2 biologicals) targeting Clostridium difficile.
■ Of the 30 antibiotics targeting priority pathogens:
- 15 are oral formulations;
- 11 are expected to have some activity against at least one critical Gram-negative priority pathogen; and
- 5 fulfill at least one of the four criteria for innovation, 1 agent against Gram-negative bacteria.
■ 3 antibiotics and combinations containing a new chemical entity have gained market authorization between 2 May 2017 and 1 July 2018.

Lancet ID publication: Analysis of the clinical antibacterial and antituberculosis pipeline

  *   Link: https://doi.org/10.1016/S1473-3099(18)30513-9

Abstract:
This analysis of the global clinical antibacterial pipeline was done in support of the Global Action Plan on Antimicrobial Resistance. The study analysed to what extent antibacterial and antimycobacterial drugs for systemic human use as well as oral non-systemic antibacterial drugs for Clostridium difficile infections were active against pathogens included in the WHO priority pathogen list and their innovativeness measured by their absence of cross-resistance (new class, target, mode of action). As of July 1, 2018, 30 new chemical entity (NCE) antibacterial drugs, ten biologics, ten NCEs against Mycobacterium tuberculosis, and four NCEs against C difficile were identified. Of the 30 NCEs, 11 are expected to have some activity against at least one critical priority pathogen expressing carbapenem resistance. The clinical pipeline is dominated by derivatives of established classes and most development candidates display limited innovation. New antibacterial drugs without pre-existing cross-resistance are under-represented and are urgently needed, especially for geographical regions with high resistance rates among Gram-negative bacteria and M tuberculosis.

Thank you
Best wishes,
Sarah Paulin, PhD
Technical Officer, Innovation, Access and Use
Essential Medicines and Health Products
Medicines, Vaccines and Pharmaceuticals
World Health Organization
Geneva, Switzerland




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