The World Health Organization (WHO) has released its latest report on the global state of antibacterial agents, highlighting both progress and ongoing challenges in the fight against antimicrobial resistance (AMR). The report indicates an increase in antibacterial agents in clinical development, rising from 80 in 2021 to 97 in 2023. However, there remains a critical need for innovative solutions to combat serious infections, especially as existing antibiotics lose effectiveness due to widespread misuse and overuse.
Key points from the WHO report include:
- Antibacterial R&D Pipeline:
- There are currently 97 antibacterial agents in clinical development.
- Of the 32 antibiotics under development targeting priority bacterial pathogens, only 12 are innovative.
- Only 4 of these 12 innovative antibiotics are effective against at least one WHO ‘critical’ pathogen.
- Innovative Agents:
- Despite some progress, the report highlights a significant lack of innovation in new antibacterial agents.
- Non-traditional agents, such as bacteriophages and microbiome-modulating agents, show promise but face regulatory and clinical study challenges.
- Recent Approvals:
- Since July 2017, 13 new antibiotics have received marketing authorization, with only 2 representing new chemical classes.
- Three non-traditional agents have been approved, all faecal-based products aimed at restoring gut microbiota to prevent recurrent Clostridioides difficile infection.
- Preclinical Pipeline:
- The preclinical pipeline remains stable and active, focusing on innovative approaches particularly against Gram-negative pathogens.
- These bacteria are especially concerning due to their high resistance to last-resort antibiotics and their ability to transfer drug resistance to other bacteria.
- Access and Innovation:
- Dr. Yukiko Nakatani, WHO’s Assistant Director-General for Antimicrobial Resistance ad interim, emphasizes the need for faster development of innovative antibacterial products and improved access for patients globally.
- There are significant gaps in the pipeline for pediatric formulations, convenient oral formulations for outpatients, and agents to address rising drug resistance.
The WHO’s annual report, which started in 2017, continues to evaluate the antibacterial R&D pipeline to ensure it aligns with the needs highlighted in the WHO bacterial priority pathogen list (BPPL). This alignment is crucial to effectively combat the growing threat of AMR and to guide future research and development efforts towards the most pressing health challenges.
