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The global shortage of innovative antibiotics encourages the emergence and spread of drug resistance
The world is still failing to develop much-needed antibacterial treatments, despite growing awareness of the urgent threat of antibiotic resistance, according to World Health Organization report. The WHO reveals that none of the 43 antibiotics currently in clinical development sufficiently address the problem of drug resistance in the world’s most dangerous bacteria.
“Persistent failure to develop, produce and distribute effective new antibiotics further fuels the impact of antimicrobial resistance (AMR) and threatens our ability to successfully treat bacterial infections,” says Dr. Hanan Balkhy, WHO Assistant Director-General for AMR.
Almost all of the new antibiotics introduced to the market in recent decades are variations of the class of antibiotics that were discovered in the 1980s.
The impact of AMR is most severe in environments with limited resources and among vulnerable groups such as infants and young children. Bacterial pneumonia and circulatory infections are one of the leading causes of infant mortality under 5 years of age. Approximately 30% of newborns with sepsis die from bacterial infections resistant to multiple first-line antibiotics. https://doi.org/10.1016/S2214-109X(17)30362-5
Findings report:
The WHO Annual Report on Antibacterial Pipelines provides an overview of antibiotics that are in the clinical phase of testing, as well as those in early product development. The aim is to assess progress and identify shortcomings related to urgent threats of drug resistance and to encourage measures to address them.
The report assesses the potential of candidates to address the most dangerous drug-resistant bacteria described in the WHO Priority Bacterial Pathogens (WHO PPL). This list, which includes 13 priority drug-resistant bacteria, has informed and led priority areas for research and development since its first publication in 2017.
The 2020 report reveals an almost static pipeline with regulatory agencies that have approved only a few antibiotics in recent years. Most of these developing agents offer limited clinical benefit over existing treatments, with 82% of recently approved antibiotics being derivatives of existing classes of antibiotics with well-established drug resistance. Therefore, rapid emergence of drug resistance to these new agents is expected.
Review concludes that “overall, the clinical pipeline and recently approved antibiotics are insufficient to address the challenges of the growing emergence and spread of antimicrobial resistance. “.
New solutions outside the traditional development path:
The lack of progress in the development of antibiotics underscores the need to explore innovative approaches in the treatment of bacterial infections. The WHO 2020 report includes for the first time a comprehensive review of non-traditional antibacterial drugs. It highlights 27 non-traditional antibacterial agents in preparation, from antibodies to bacteriophages and therapies that support the patient’s immune response and weaken the effect of bacteria.
High failure rates and impact on market dynamics:
The report notes that there are some promising products at different stages of development. However, only a fraction of them will ever be placed on the market due to economic and inherent scientific challenges in the drug development process. This, together with a 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 is still run by small and medium-sized enterprises. These companies often strive to fund their products in the late stages of clinical development or until regulatory approval is obtained.
Opportunity for COVID-19:
The COVID-19 crisis has deepened global understanding of the health and economic implications of an uncontrolled pandemic. He also highlighted gaps in sustainable funding to address these risks, including investment in research and development of antimicrobial drugs and vaccines, while revealing what rapid progress can be made when there is sufficient political will and enterprise.
“The opportunities arising from the COVID-19 pandemic must be harnessed to highlight the need for sustainable investment in research and development of new and effective antibiotics,” said Haileyesus Getahun, Director of AMR Global Coordination at WHO. “Antibiotics are the Achilles’ heel for universal health insurance and our global health security. We need a sustainable global effort, including pooling mechanisms and new and additional investments to meet the magnitude of the threat to AMR. “
Global initiatives:
To address funding shortfalls and launch sustainable investments in antibiotic development, the WHO and its partner Drugs for Neglected Diseases intimately (DNDI) established the Global Partnership for Antibiotic Research and Development (GARDP) develop some of the innovative treatments included in the report. In addition, the WHO works closely with other nonprofit funding partners, such as CARBON-X to “suppress” and accelerate antibacterial research.
Another important new initiative is AMR Equity Fund, a partnership established by a coalition of pharmaceutical companies, philanthropy, the European Investment Bank, with the support of the WHO, which aims to strengthen and accelerate the development of antibiotics through global joint funding. The Fund is expected to play an important role in ensuring that the most innovative and promising products receive the necessary funding.
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