Lack of innovation risks compromising performance of antibiotics (WHO)

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This report describes the clinical and preclinical portfolio of antibacterials as “stagnant and far from meeting global needs”. Since 2017, only 12 antibiotics have been approved, 10 of which belong to existing classes with established mechanisms of antimicrobial resistance (AMR).

“There is a large gap in the discovery of antibacterial treatments, and even more so in the discovery of innovative treatments,” said Dr Hanan Balkhy, WHO Deputy Director-General for AMR.

“This presents a serious challenge to overcoming the growing pandemic of antimicrobial resistance and leaves each of us increasingly vulnerable to bacterial infections, including the simplest infections,” Dr Balkhy said.

Monoclonal antibodies and other non-traditional approaches are in order

According to WHO annual analyses, in 2021 there were only 27 new antibiotics in clinical development against priority pathogens, compared to 31 in 2017. In the preclinical stage – before clinical trials can begin – the number of products has remained relatively constant over the past 3 years.

It currently takes about 10 to 15 years to bring a candidate antibiotic from preclinical to clinical stage.

More broadly, 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. Among the latter, we can cite monoclonal antibodies and bacteriophages, which are viruses capable of destroying bacteria.

Since antibiotics now have a limited lifespan before drug resistance emerges, non-traditional approaches offer new opportunities to tackle infections due to antimicrobial resistant bacteria from different angles, as they can be used in a complementary and synergistic way or as alternatives to established therapies.

1 in 15 drugs in preclinical development will reach patients

Barriers to new product development include lengthy approval process, high cost, and low success rates.

It currently takes about 10 to 15 years to bring a candidate antibiotic from preclinical to clinical stage.

For existing classes of antibiotics, on average, only one in 15 drugs in preclinical development will reach patients. For new classes of antibiotics, only one in 30 candidates will reach patients.

Of the 27 antibiotics in clinical development that attack priority pathogens, only six fulfill at least one of the WHO innovation criteria.

Resistance is reported within three days of release

The lack of innovation quickly compromises the effectiveness of the limited number of new antibiotics that come to market. On average, resistance is reported for most new agents two to three years after their introduction to the market.

“The pace and success of innovation is well below what we need to preserve the gains of modern medicine against age-old but devastating diseases like neonatal sepsis,” said the Global Coordinating Director of the RAM at WHO, Dr Haileyesus Getahun. About 30% of newborns with sepsis die due to bacterial infections resistant to first-line antibiotics.

SMEs that lack support

The Covid-19 pandemic has also hampered progress, delayed clinical trials and diverted attention from already constrained investors.

Much of the innovation in antibiotics is driven by small and medium-sized companies, which struggle to find investors to fund the late stages of clinical development through regulatory approval.

It is not uncommon for companies to suspend development of their products for several years, hoping to secure the necessary funding to continue development at a later stage or for the product to be purchased by another company. Many go bankrupt.

There is therefore an urgent need for governments and the private sector to make concerted investments in research and development to accelerate and expand the portfolio of antibiotics, especially those that can have an impact in low-resource settings, which are most affected by RAM.

The WHO believes that countries “must work together to find sustainable solutions and incentives for research, development and innovation and to create a viable ecosystem for antibiotics”.

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