The World Health Organization (WHO) reported that only twelve new antibiotics have been approved since 2017, ten of which belong to existing classes that have already been proven to have resistance to some bacteria.
He did so in his work "Antibacterial agents in clinical and preclinical development: overview and analysis" , which evaluates approved and investigational drugs during the period 2017-2021.
"There is a significant gap in the discovery of antibacterial treatments, and even more so in the discovery of innovative treatments," said Hanan Balkhy, WHO Assistant Director-General on Antimicrobial Resistance (AMR).
He continued: "This presents a serious challenge to overcoming the growing pandemic of antimicrobial resistance and leaves us increasingly vulnerable to bacterial infections, including simpler infections."
According to the WHO’s annual analyses, in 2021 there were only 27 new antibiotics in clinical development (human testing) against priority pathogens, compared to 31 products that were being tested in 2017.
In the preclinical stage, before clinical trials can begin, the number of products has remained relatively constant over the past few years.
More generally, the report describes that "of the 77 antibacterial agents in clinical development, 45 are ’traditional’ direct-acting small molecules and 32 are ’non-traditional’ agents."
Examples of the latter are monoclonal antibodies and bacteriophages, which are viruses that can destroy bacteria.
"Given that antibiotics have a limited shelf life before drug resistance emerges, non-traditional approaches offer new opportunities to address infections caused by antimicrobial-resistant bacteria from different angles, as they can be used in a complementary and synergistic or as alternatives to established therapies," the agency said in a statement.
The WHO warned that "barriers to the development of new products include the long path to approval, high cost and low success rates."
It currently takes approximately 10 to 15 years for an antibiotic candidate to progress from the preclinical stage to the clinic.
For antibiotics from existing classes, on average, only one in 15 drugs in preclinical development will reach patients, while for new classes of antibiotics, only one in 30 candidates will reach patients.
Of the 27 antibiotics in clinical development that address priority pathogens, only six meet at least one of the WHO innovation criteria.
Lack of innovation quickly undermines the effectiveness of the limited number of new antibiotics that come to market.
On average, resistance to most new agents is reported 2-3 years after market entry.
As an example of the problem, approximately 30% of newborns with sepsis die due to bacterial infections resistant to first-line antibiotics.
The Covid-19 pandemic has also hampered progress, delayed clinical trials and diverted the attention of already limited investors.
"Urgent and concerted investments in research and development are needed by governments and the private sector to accelerate and expand the pipeline of antibiotics, especially those that can have an impact in low-resource settings, which are most affected by AMR. "said the WHO.
And he concluded: "Countries must work together to find sustainable solutions and incentives for research, development, innovation and to create a viable ecosystem for antibiotics."
