A new report from the World Health Organization (WHO) has highlighted the ongoing global failure to develop desperately needed antibacterial treatments despite growing awareness of the threat of antibiotic resistance.
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. In this new report, the WHO has revealed that 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.
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.”
Dr Hanan Balkhy, WHO Assistant Director General on AMR, said: “The persistent failure to develop, manufacture, and distribute effective new antibiotics is further fuelling the impact of antimicrobial resistance (AMR) and threatens our ability to successfully treat bacterial infections.”
Antibiotic development
The annual Antibacterial Pipeline Report reviews antibiotics that are in the clinical stages of testing as well as those in early product development, evaluating the potential of the candidates to address the most threatening drug-resistant bacteria outlined in the WHO Bacterial Priority Pathogens List (WHO PPL).
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.
This lack of process highlights the need to explore innovative approaches to treat bacterial infections and the report includes a comprehensive overview of non-traditional antibacterial medicines.
It highlights 27 non-traditional antibacterial agents in the pipeline ranging from antibodies to bacteriophages and therapies that support the patient’s immune response and weaken the effect of the bacteria.
Financial incentive
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. It 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.
To address gaps in funding and drive sustainable investments in antibiotics development, the WHO and its partner Drugs for Neglected Diseases initiative (DNDi) have set up the Global Antibiotic R&D Partnership (GARDP). In addition, the WHO has been working closely with other non-profit funding partners such as the CARB-X to accelerate antibacterial research.
COVID-19
The COVID-19 pandemic has highlighted the health and economic implications of an uncontrolled pandemic, as well as the gaps in sustainable funding to address these risks, including investments in R&D of antimicrobial medicines and vaccines, whilst revealing what rapid progress can be made when there is enough political will and enterprise.
Haileyesus Getahun, Director of AMR Global Coordination at WHO, said: “Opportunities emerging from the COVID-19 pandemic must be seized to bring to the forefront the needs for sustainable investments in R&D of new and effective antibiotics.
“Antibiotics present the Achilles heel for universal health coverage and our global health security. We need a global sustained effort including mechanisms for pooled funding and new and additional investments to meet the magnitude of the AMR threat.”
Another important new initiative is the AMR Action Fund, a partnership that was set up by a coalition of pharmaceutical companies, philanthropies, the European Investment Bank, with the support of the WHO, that aims to strengthen and accelerate antibiotic development through global pooled funding.
