The pace of development of new antibacterial drugs has not kept up with the growing resistance to them.
Antibiotics and other antimicrobials play a critical role in reducing morbidity and mortality in both humans and animals. However, as bacteria, viruses, fungi and parasites gradually mutate, new strains of micro-organisms develop that become resistant to these drugs, making treatment more difficult and increasing the risk of severe disease and death.
Today, antibiotic resistance is becoming a global problem that needs to be addressed urgently.
Many antibiotics don’t work
Almost all of the new antibiotics and other antimicrobial drugs that have come onto the market in recent decades are just varieties of previously discovered drugs. Many of them don’t work today. Thus, since 2017, only 12 antibiotics have been approved, 10 of which belong to existing classes with antimicrobial resistance.
As a result, millions of people die from infectious diseases caused by bacteria, parasites, viruses and fungi.
A 2021 WHO report describes clinical and preclinical development of antibacterial drugs as “stagnant” and far from meeting global demand.
«Существует серьезный пробел в открытии антибактериальных методов лечения, и еще больший – в открытии инновационных методов лечения, – сказала Ханан Балхи, помощник Генерального директора ВОЗ. – Это представляет собой серьезную проблему для преодоления нарастающей устойчивости к противомикробным препаратам и делает каждого из нас все более уязвимым к бактериальным инфекциям, включая самые простые».
Clinical Development
According to the WHO, only 27 new antibiotics against pathogens of priority diseases were in clinical development in 2021, compared with 31 drugs in 2017. At the preclinical stage – before the start of clinical trials – the number of drugs has remained relatively stable over the past 3 years.
Barriers to new drug development include long approval processes, high costs, and low success rates. Currently, the development of antibiotics from the preclinical to the clinical stage takes approximately 10-15 years. On average, only one out of every 15 drugs in preclinical development will reach patients. As for new classes of antibiotics – only one of 30 candidates.
Of the 27 antibiotics in clinical development for priority diseases, only six meet at least one of the WHO criteria for innovation. On average, resistance to most new drugs occurs 2-3 years after entering the market.
The COVID-19 pandemic has also hindered progress, delayed clinical trials and distracted investors. Much of the innovation in antibiotics comes from small and medium-sized companies that struggle to fund clinical development. Therefore, WHO believes that urgent and concerted investment in research and development of next-generation antibiotics is needed today.