Work to develop new antibiotics is ‘stagnant’ and does not meet global needs, a new report from the World Health Organization has warned.
The 2021 annual report says since 2017 only 12 antibiotics have been approved, 10 of which belong to existing classes with established mechanisms of antimicrobial resistance (AMR).
In 2021 there were 27 new antibiotics in clinical development against priority pathogens – down from 31 products in 2017 – while the number of products in the preclinical stage has remained constant over the past three years.
Dr Hanan Balkhy, WHO assistant director general on AMR, said: “There is a major gap in the discovery of antibacterial treatments, and more so in the discovery of innovative treatments.
“This presents a serious challenge to overcoming the escalating pandemic of antimicrobial resistance and leaves every one of us increasingly vulnerable to bacterial infections including the simplest infections.”
The report says of the 77 anti-bacterial agents in clinical development, 45 are ‘traditional’ direct-acting small molecules and 32 are ‘non-traditional’ agents.
It takes about 10-15 years to progress an antibiotic candidate from the preclinical to the clinical stages and for antibiotics in existing classes, on average, one of every 15 drugs in preclinical development reaches patients. For new classes of antibiotics, one in 30 candidates reaches patients.
Of the 27 antibiotics in the clinical pipeline that address priority pathogens, six fulfil at least one of WHO’s criteria for innovation.
Dr Haileyesus Getahun, WHO director of AMR global coordination, warned that time is running out to get ahead of antimicrobial resistance.
“The pace and success of innovation is far below what we need to secure the gains of modern medicine against age-old but devastating conditions like neonatal sepsis,” he added.
The COVID-19 pandemic has also hampered progress, delayed clinical trials, and diverted attention of the already limited investors, but most of the innovation in antibiotics is driven by small- and medium-sized companies and they are struggling to find investors to finance late-stage clinical development up to regulatory approval.
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