Antimicrobial resistance
Analysis of the antibacterial pipeline
WHO annually analyzes the pipeline for agents that target bacteria (antibacterials) to facilitate the setting of priorities for R&D. For this analysis, WHO reviews publicly available information on the current pipeline of antibacterial agents in preclinical and clinical (phase I-III) development to assess which of these drug candidates target the WHO identified bacterial priority pathogens, Mycobacterium tuberculosis, and Clostridium difficile.
Pipeline of antibacterial agents in clinical development
As of November 2021, a total of 80 products (46 antibiotics and 34 non-traditional antibacterial agents) were in clinical development, three of which were in the pre-registration phase. Of the 46 traditional antibiotics, 28 (61%) were reported to be active against WHO bacterial priority pathogens, 13 (28%) against M. tuberculosis and five (11%) exclusively against C. difficile.
The Observatory developed a data visualization of the analysis where candidate products can be explored by type, pathogen category, phase of clinical development, and expected activity against priority pathogens. There is also an assessment of their innovativeness and whether a new chemical entity is involved. The route of administration, antibiotic class and developers are also reported. See the link below, which also includes further details on the scope, analysis and limitations:
Data visualization of antibacterial agents in clinical development
Pipeline of antibacterial agents in preclinical development
As of September 2021, there were 217 antibacterial agents/programmes at a preclinical stage by 121 commercial and non-commercial entities. A total of 95 agents (43.8%) have been classified by the product developers as species specific. Of these, 44 agents target WHO critical Gram-negative bacteria: 21 target Pseudomonas aeruginosa, eight target Acinetobacter baumannii and 15 target Enterobacterales. In addition, 19 species-specific agents are directed against Staphylococcus aureus and 20 against M. tuberculosis. The annual analysis of the preclinical pipeline to date shows that from one year to the other, one third of the development programmes are discontinued.
The Observatory developed a data visualization for an overview of each preclinical pipeline project, which can be explored by country of development, type and size of developer, preclinical stage, infection stage being targeted, route of administration, treatment modality and mode of action. Some characteristics of the products are also reported such as whether the product is new or repurposed, is a new chemical class or if it has a new mechanism of action. Details of pathogen-specific products and activity against drug-resistant phenotypes are also reported:
Data visualization of antibacterial agents in preclinical development
Analysis of bacterial vaccines in clinical and preclinical development
In 2022, WHO produced the first analysis of the bacterial vaccine candidates in preclinical and clinical development against drug-resistant bacteria.
As of September 2021, a total of 155 candidate vaccines in active clinical (61) or preclinical development (94) were identified. Of the 61 candidate vaccines in an active status of clinical development, 10 candidate vaccines target “critical” priority pathogens. The majority of candidate vaccines were in phase II of development (43%; 26), while 30% (18) were in phase III and 28% (17) were in phase I of development. 84% (51) are for prophylactic use.
The Observatory developed an interactive data visualization for an overview of vaccine pipeline projects in clinical and preclinical development, which can be explored by stage of development, pathogen category, pathogen targeted, vaccine approach, whether the vaccine targets multiple pathogens, whether the vaccine is prophylactic or therapeutic, administration route, and characteristics of the vaccine developer:
Data visualization of bacterial vaccines in clinical and preclinical development