Lack of innovation set to undermine antibiotic performance and health gains

The development of new antibacterial treatments is insufficient to counter the growing threat of antibiotic resistance, according to the World Health Organization’s annual pipeline report. A 2021 report describes clinical and preclinical antibacterial pipelines as stagnant and far from meeting global needs. Since 2017, only 12 antibiotics have been approved, 10 of which belong to current classes with well-established mechanisms of antimicrobial resistance (AMR).

“There is a huge gap in the discovery of antibacterial treatments, and even more so in the discovery of innovative treatments,” Dr Hanan Balkhi, Assistant Director-General of the World Health Organization (WHO) on antimicrobial resistance said. “This presents a serious challenge to overcome the escalating pandemic of antimicrobial resistance and leaves each of us increasingly vulnerable to bacterial infections, including the simplest.”

According to the World Health Organization’s annual analyzes, in 2021 there were only 27 new antibiotics in clinical development against priority pathogens, down from 31 products in 2017. In the preclinical phase – before clinical trials began – the number of products remained constant relatively over the past. 3 years.

More broadly, the report describes that of the 77 antibacterial agents in clinical development, 45 are direct-acting ‘conventional’ small molecules and 32 are ‘unconventional’ agents. Examples of the latter include monoclonal antibodies and phages, which are viruses that can destroy bacteria. Since the lifespan of antibiotics is now limited before the emergence of drug resistance, unconventional approaches offer new opportunities to treat infections from antimicrobial resistant bacteria from different angles as they can be used complementary and synergistically or as alternatives to established therapies.

Barriers to developing new products include the long approval process, high cost, and low success rates. It currently takes approximately 10-15 years for an antibiotic candidate to progress from preclinical to clinical stages. For antibiotics in existing classes, on average, only 1 in 15 patients will reach preclinical development. For new classes of antibiotics, only one in 30 candidates will reach patients.

Of the 27 antibiotics in the pipeline that address priority pathogens, only six meet at least one of the WHO’s criteria for innovation. A lack of innovation undermines the effectiveness of the limited number of new antibiotics that reach the market. On average, resistance to most new agents is reported 2-3 years after market entry.

“Time is running out to advance antimicrobial resistance, and the pace and success of innovation is far less than we need to secure the gains of modern medicine against ancient and devastating conditions such as neonatal sepsis,” Dr Heilisos Getahun, Director of the Global Coordination of Antimicrobial Resistance at the World Health Organization. Approximately 30% of newborns with sepsis die from first-line antibiotic-resistant bacterial infections.

The COVID-19 pandemic has also stymied progress, delayed clinical trials, and distracted already limited investors. Much of the innovation in antibiotics is driven by small and medium-sized companies, which are struggling to find investors to fund late-stage clinical development until regulatory approval. It is not uncommon for companies to halt product development for several years, hoping to secure funding to continue development at a later stage or that the product may be purchased by another company. Many people go bankrupt.

Therefore, urgent and coordinated investment in research and development by governments and the private sector is needed to accelerate and expand the supply line of antibiotics, especially those that can have an impact in low-resource settings, which are most affected by antimicrobial resistance. Countries must work together to find sustainable solutions and incentives for research, development and innovation and to create a viable antibiotic ecosystem.

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