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Lack of innovation that would undermine the effect of antibiotics and health
According to the World Health Organization’s annual report, the development of new antibacterial treatments is not appropriate to address the growing threat of antibiotic resistance. 2021 report describes the antibacterial clinical and preclinical system as stagnant and far from meeting global needs. As of 2017, only 12 antibiotics have been approved, of which 10 belong to existing classes with established mechanisms of antimicrobial resistance (AMR).
“There is a big gap in the detection of antibacterial treatments, and even more in the detection of innovative treatments,” said Dr. Hanan Balkhy, WHO Assistant Director General for AMR. “This poses a serious challenge to overcoming an escalating pandemic of antimicrobial resistance and makes each of us increasingly vulnerable to bacterial infections, including the simplest infections.”
According to WHO annual analyzes, in 2021 there were only 27 new antibiotics in clinical development against priority pathogenswhich is less than the 31 products in 2017. In the preclinical phase – before clinical trials can begin – the number of products has remained relatively constant over the last 3 years.
In a broader sense, the report describes that, of the 77 antibacterial agents in clinical development, 45 are traditional small molecules of direct action and 32 are non-traditional agents. Examples of the latter are monoclonal antibodies and bacteriophages, which are viruses that can kill bacteria. Because antibiotics now have a limited lifespan before drug resistance emerges, nontraditional approaches offer new opportunities to fight resistant bacterial infections from different angles because they can be used complementary and synergistically or as alternatives to established therapies.
Obstacles to new product development include a long road to approval, high prices, and low success rates. It currently takes approximately 10-15 years for an antibiotic candidate to progress from preclinical to clinical stages. For antibiotics in existing classes, on average, only one in every 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 the clinical trial that address priority pathogens, only 6 meet at least one of the WHO innovation criteria. The lack of innovation is rapidly undermining the effectiveness of the limited number of new antibiotics coming on the market. On average, resistance to most new agents was noted 2-3 years after entering the market.
“Time is running out to be ahead of antimicrobial resistance, the pace and success of innovation is far below what we need to ensure the success of modern medicine against old but devastating conditions like neonatal sepsis,” said Dr. Haileyesus Getahun, director of the Global AMR Coordination of the World Health Organization. Approximately 30% of newborns with sepsis they die from bacterial infections resistant to first-line antibiotics.
The COVID-19 pandemic also prevented progress, delayed clinical trials and drew the attention of already limited investors. Much of the innovation in antibiotics has been driven by small and medium-sized companies, which are struggling to find investors to fund the late stages of clinical development until regulatory approval. It is not uncommon for companies to suspend product development for a few years, hoping to secure funding to continue development at a later stage or that the product could be purchased by another company. Many go bankrupt.
Therefore, urgent and coordinated investment by governments and the private sector in research and development is needed to accelerate and expand the supply of antibiotics, especially those that may be affected in low-resource environments, which are most affected by AMR. Countries should work together to find sustainable solutions and incentives for research, development, innovation and the creation of a sustainable antibiotic ecosystem.
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Sources 2/ https://www.who.int/news/item/22-06-2022-22-06-2022-lack-of-innovation-set-to-undermine-antibiotic-performance-and-health-gains The mention sources can contact us to remove/changing this article |
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