There are scientific and technical challenges in discovering novel antibacterials that are both effective against bacteria and safe for humans.
The World Health Organisation (WHO) has released its latest report setting out the state of development of antibacterials. The WHO notes that although the number of antibacterial agents in the clinical pipeline increased from 80 in 2021 to 97 in 2023, there is urgent need for ‘new innovative agents to treat serious infections, as well as replacing existing treatments that are becoming ineffective due to widespread use.’
The report: 2023 Antibacterial agents in clinical and preclinical development: an overview and and analysis, which has been published each year since 2017, evaluates whether the current R&D pipeline properly addresses infections caused by the drug-resistant bacteria most threatening to human health, as listed in the 2024 WHO Bacterial Priority Pathogen List (BPPL). The WHO said that both documents are aimed at steering antibacterial R&D to better counter the growing threat of antimicrobial resistance (AMR).
The report highlights concerns that along with the low number of new antibacterials in the pipeline, there is also a lack of innovation. ‘Of the 32 antibiotics under development to address BPPL infections, only 12 can be considered innovative,’ the WHO said. The WHO added that of the 12 considered innovative, four of these are active against at least one BPPL high-risk pathogen.
‘Antimicrobial resistance is only getting worse,’ said Dr Yukiko Nakatani, the WHO’s interim assistant director general for antimicrobial resistance. ‘Innovation is badly lacking, yet even when new products are authorised, access is a serious challenge. Antibacterial agents are simply not reaching the patients who desperately need them, in countries of all income levels.’
The WHO’s concerns were echoed last month at the SCI/RSC Symposium on Anti-Infectives in Drug Discovery where Dr Clive Mason, programme director (AMR) at LifeArc warned of the ‘deepening crisis in antibiotic R&D.’ ‘Much of the work on new treatments we are seeing is being done by universities and small companies,’ Mason said. This was attributed, in part, to the lack of financial incentives, which has led large pharmaceutical companies to leave the market, Mason added.
Commenting on development of new antibacterials, the WHO said: ‘Looking at newly approved antibacterials since 1 July 2017, 13 new antibiotics have obtained marketing authorisation, but only two represent a new chemical class, and can be termed innovative, underscoring the scientific and technical challenge in discovering novel antibacterials that are both effective against bacteria and safe for humans.’
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