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WHO: ‘Serious lack’ of antibiotics in development to address resistance
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In a new report, WHO warned of a “serious lack” of new antibiotics in development to address the growing threat of antimicrobial resistance.
The world health agency said that as of May, the antibiotic pipeline included 51 antibiotics and 11 biologicals but few innovative solutions. It said the pipeline is filled with short-term fixes — drugs that are modifications of existing classes of antibiotics.
A dried-up pipeline and insufficient investment in basic science, drug discovery and clinical development means there are fewer potential treatments for important antibiotic-resistant infections like drug-resistant tuberculosis, which kills 250,000 people each year, according to WHO.
The agency also singled out gram-negative pathogens Pseudomonas aeruginosa, Acinetobacter baumannii and Enterobacteriaceae, including Klebsiella pneumoniae and Escherichia coli, as “the most critical priority for antibiotic research and development” because “strains are emerging worldwide that cannot be treated with any of the antibiotics currently on the market.”
“Antimicrobial resistance is a global health emergency that will seriously jeopardize progress in modern medicine,” WHO Director Tedros Adhanom Ghebreyesus, PhD, said in a statement. “There is an urgent need for more investment in research and development for antibiotic-resistant infections including TB, otherwise we will be forced back to a time when people feared common infections and risked their lives from minor surgery.”
According to WHO, seven new agents for TB are currently in clinical trials, including just one in phase 3 development.
The agency said nine of 11 biologicals in early-stage development target priority pathogens Staphylococcus aureus and P. aeruginosa, but it is unclear if such treatments could serve as real alternatives to antibiotics. It said the pipeline includes few oral antibiotics, which are essential for treating infections outside of the hospital or in resource-limited settings.
According to WHO, based on the average 7-year development time from phase 1 to approval, the current pipeline could lead to the approval of 10 antibiotics or biologicals over the next 5 years, which the agency said is insufficient to tackle the impending threat of antimicrobial resistance.
It said cooperation by the pharmaceutical industry will be key to bringing new options onto the market and that new treatments must be combined with infection prevention and control and antimicrobial stewardship efforts. – by Gerard Gallagher
Reference:
WHO. Antibacterial agents in clinical development — an analysis of the antibacterial clinical development pipeline, including Mycobacterium tuberculosis. 2017. http://www.who.int/medicines/en/. Accessed September 19, 2017.
Disclosure: Tedros reports no relevant financial disclosures.
Perspective
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Amesh Adalja, MD, FIDSA
The WHO report “Antibacterial Agents in Clinical Development” provides important evidence of the dire situation the world faces with antimicrobial resistance. This pipeline analysis importantly notes that of the products identified in the pipeline, only eight are truly innovative. With bacteria, resistance is the norm, is inevitable, and should be expected. Medications with new mechanism of action that are not modifications of existing drugs are one way to forestall the development of resistance, and more of this type of countermeasure is needed. Additionally, the breaking out of biological agents such as antibody- and phage-based treatments are important because these treatments change the paradigm of the treatment of infectious disease by being narrowly targeted. These nontraditional products have the capacity, if their efficacy can be shown, to revolutionize the treatment of infections. The report underscores the need for the world’s best minds to address antimicrobial resistance with the urgency that it deserves because the status quo is not sufficient to tame billions of years of evolution.
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