Lack of innovation set to undermine antibiotic performance and health gains

Development of new antibacterial treatments is inadequate to address the mounting threat of antibiotic resistance, according to the annual pipeline report by the World Health Organization. The 2021 report describes the antibacterial clinical and preclinical pipeline as stagnant and far from meeting global needs. Since 2017 only 12 antibiotics have been approved, 10 of which classes have established mechanisms of antimicrobial resistance (AMR).

“There is a major gap in the discovery of antibacterial treatments, and more so in the discovery of innovative treatments,” said Dr. Hanan Balkhy, WHO Assistant Director General on AMR. “This presents a serious challenge to the pandemic of antimicrobial resistance and leaves us vulnerable to bacterial infections including the simplest infections.”

According to WHO annual analyses, in 2021 there were only 27 new antibiotics in clinical development against priority pathogens, down from 31 products in 2017. In the preclinical stage – 3 years.

More broadly the report describes that, of the 77 anti-bacterial 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. Antibiotics have shown that antimicrobial infections are resistant to bacteria from different angles because they can be used complementary and synergistically or as alternatives to established therapies.

Barriers to development of new products include the length of route to approval, high cost and low success rates. It takes approximately 10-15 years to progress the antibiotic candidate from the preclinical to the clinical stages. Antibiotics will reach patients. For new classes of antibiotics, only one in 30 candidates will reach patients.

Of the 27 antibiotics in the clinical pipeline that address priority pathogens, only six fulfill at least one of WHO’s criteria for innovation. The lack of innovation rapidly undermines the effectiveness of the limited number of new antibiotics that reach the market. 2-3 years post market entry.

“Time is running out of antimicrobial resistance, the pace and success of innovation is where we need to secure the benefits of modern medicine against old age but devastating conditions like neonatal sepsis,” said Dr. Haileyesus Getahun, WHO Director of AMR Global Coordination. Approximately 30% of newborns with sepsis due to bacterial infections resistant to first-line antibiotics.

The COVID-19 pandemic has also hampered progress, delayed clinical trials, and diverted attention from the already limited investors. Much of the innovation in antibiotics is driven by small- and medium-sized companies, which are struggling to find investors to finance late-stage clinical development up to regulatory approval. It is not uncommon for companies to suspend product development for several years, in the hope of securing the financing to continue development at a later stage or that the product may be purchased by another company. Many go bankrupt.

Urgent and concerted investments in research and development by the private sector are therefore needed to accelerate and expand the pipeline for antibiotics, especially those which are worst-affected by AMR. Countries should work together to find sustainable solutions and incentives for research, development, innovation and to create a viable ecosystem for antibiotics.

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