None of the 43 antibiotics that are currently in clinical development sufficiently address the problem of drug resistance in the world’s most dangerous bacteria, according to a report from the World Health Organization (WHO).
“The persistent failure to develop, manufacture, and distribute effective new antibiotics is further fueling the impact of antimicrobial resistance (AMR) and threatens our ability to successfully treat bacterial infections,” says Hanan Balkhy, MD, WHO Assistant Director General on AMR.
Almost all the new antibiotics that have been brought to market in recent decades are variations of antibiotic drugs classes that had been discovered by the 1980s.
WHO’s annual Antibacterial Pipeline Report reviews antibiotics that are in the clinical stages of testing as well as those in early product development. The aim is to assess progress and identify gaps in relation to urgent threats of drug resistance and to encourage action to fill those gaps.
The report evaluates the potential of the candidates to address the most threatening drug-resistant bacteria outlined in the WHO Bacterial Priority Pathogens List (WHO PPL). This list, which includes 13 priority drug-resistant bacteria, has informed and guided priority areas for research and development since its first publication in 2017.
The 2020 report reveals a near static pipeline with only few antibiotics being approved by regulatory agencies in recent years. Most of these agents in development offer limited clinical benefit over existing treatments, with 82% of the recently approved antibiotics being derivatives of existing antibiotic classes with well-established drug resistance. Therefore, rapid emergence of drug resistance to these new agents is expected.
The review concludes that “overall, the clinical pipeline and recently approved antibiotics are insufficient to tackle the challenge of increasing emergence and spread of antimicrobial resistance.”
The report notes that there are some promising products in different stages of development. However, only a fraction of these will ever make it to the market due to the economic and inherent scientific challenges in the drug development process. This, along with the small return on investment from successful antibiotic products, has limited the interest of major private investors and most large pharmaceutical companies.
The report confirms that the preclinical and clinical pipeline continue to be driven by small- and medium-sized companies. These enterprises often struggle to finance their products to the late stages of clinical development or until regulatory approval is obtained.
