Why the new antibiotic development report is lacking innovations

Kampala, Uganda | THE INDEPENDENT | The World Health Organization (WHO) has released its latest report on antibacterial agents, including antibiotics, in clinical and preclinical development worldwide showing an increase in the number of agents in the pipeline from 80 in 2021 to 97. First released in 2017, this annual report evaluates whether the current research and development (R&D) pipeline properly addresses infections caused by the drug-resistant bacteria most threatening to human health.

The findings of the report show that while there is an increase in the number of drugs in the pipeline, the number is too small given how long research usually takes and the likelihood of failure. They also note that there are gaps across the entire pipeline, including in products for children, oral formulations more convenient for outpatients, and agents to tackle rising drug resistance, also referred to as anti-microbial resistance (AMR).

Currently, of the 32 antibiotics under development to address infections caused by pathogens that the WHO has listed as a priority, only 12 are considered innovative.  Furthermore, the report shows, just 4 of these 12 are active against at least 1 WHO ‘critical’ pathogens which have been ranked to present the highest risk. Looking at newly approved anti-bacterial since 1 July 2017, 13 new antibiotics have obtained marketing authorization but only 2 represent a new chemical class and can be termed innovative, as they are both approved as effective against bacteria and safe for humans.

“Antimicrobial resistance is only getting worse yet we’re not developing new trailblazing products fast enough to combat the most dangerous and deadly bacteria,” said Dr Yukiko Nakatani, WHO’s Assistant Director-General for Antimicrobial Resistance ad interim said in a statement accompanying the report. “Innovation is badly lacking yet, even when new products are authorized, access is a serious challenge. Antibacterial agents are simply not reaching the patients who desperately need them, in countries of all income levels.”

AMR occurs when bacteria, viruses, fungi, and parasites no longer respond to medicines, making people sicker and increasing the risk of spread of infections that are difficult to treat, illness, and death. AMR is driven largely by the misuse and overuse of antimicrobials.

The report shows that innovators are now resorting to non-traditional approaches to come up with effective solutions such as bacteriophages, antibodies, anti-virulence agents, immune-modulating agents, and microbiome-modulating agents to be used either as complements or alternatives to antibiotics.

With these findings, WHO is pushing for greater transparency and collaboration to help scientists and drug developers generate more interest and funding for drug development for novel antibacterial agents. When it comes to non-traditional approaches, the health body calls for more efforts to facilitate clinical studies and assessments of these products, to help determine when and how to use these agents clinically.

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