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CIDRAP- Stewardship / Resistance Scan for Jun 22, 2022- Global antibiotic pipeline;  AMR surveillance data sharing

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  • CIDRAP- Stewardship / Resistance Scan for Jun 22, 2022- Global antibiotic pipeline;  AMR surveillance data sharing

    Stewardship / Resistance Scan for Jun 22, 2022

    Global antibiotic pipeline;
    AMR surveillance data sharing

    Filed Under:
    Antimicrobial Stewardship

    WHO issues another dire antibiotic pipeline report

    The World Health Organization (WHO) today released another disappointing report on the state of the antibiotic development pipeline.

    Issued annually since 2017 as part of the WHO's efforts to prioritize and coordinate the global research and development of new antibiotics, the report presents an analysis of antibacterial agents in the clinical and preclinical pipeline. Previous reports have characterized the antibiotic development pipeline as insufficient for tackling the emergence and spread of antimicrobial resistance (AMR), suggesting that most of the antibiotics in development offer little benefit over existing treatments and that too few are novel drugs that target the multidrug-resistant bacterial species the WHO has deemed "critical" and "priority" pathogens.

    In the new analysis, the WHO says the pipeline remains stagnant, with only 27 new antibiotics against priority pathogens in development—down from 31 in 2017—and the number of products in the preclinical pipeline constant over the past 3 years. Of the 27 products targeting priority pathogens, only 6 fulfill at least one of the agency's criteria for innovation, and only 2 are active against "critical" pathogens.

    Only 12 new antibiotics have been approved by the US Food and Drug Administration or European Medicines Agency since 2017, and 10 of those belong to existing antibiotic classes where resistance mechanisms are established.

    The report also notes that, of the 77 antibacterial agents in development, 45 are "traditional" direct-acting small molecules and 32 are "non-traditional" agents, including monoclonal antibodies, bacteriophages, and microbiome-modulating agents. The WHO says these products could provide a new approach to tackling drug-resistant infections, either as adjuncts or antibiotic alternatives, but many are in the early clinical stages and will face major developmental hurdles.

    "There is a major gap in the discovery of antibacterial treatments, and more so in the discovery of innovative treatments," Hanan Balkhy, MD, WHO assistant director-general on AMR, said in a press release. "This presents a serious challenge to overcoming the escalating pandemic of antimicrobial resistance and leaves every one of us increasingly vulnerable to bacterial infections, including the simplest infections."

    The WHO says "urgent and concerted" investments in research and development by governments and the private sector are needed to accelerate and expand the pipeline.
    Jun 22 WHO press release
    Jun 22 WHO 2021 antibiotic pipeline report

    New online platform for sharing AMR data launched

    Nonprofit health organization Vivli yesterday announced the launch of a new online platform where pharmaceutical and biotech companies can share antibiotic susceptibility data on infection-causing bacterial pathogens.

    The Antimicrobial Resistance (AMR) Register will enable companies to securely share AMR surveillance data they collect with researchers, national governments, and multilateral organizations such as the WHO, Centers for Disease Control and Prevention, and the United Nations. Vivli says the aim of the AMR Register is to make the large volumes of raw susceptibility data collected by pharmaceutical and biotech companies all accessible in one place for researchers, who can use it to map patterns of resistance, identify new drug-resistant pathogens, shape policies aimed at halting the spread of AMR, and spur innovation around new antimicrobials.

    "Our understanding of how to control antimicrobial resistant infections and how best to protect human health hinges on better access to surveillance data," Marc Mendelson, PhD, chair of the AMR Register scientific advisory board, said in a press release. "Biopharmaceutical company data is a vital missing link in AMR surveillance, making the research enabled by the AMR register critical to mitigating the AMR pandemic and protecting the effectiveness of antibiotics, now and in the future."

    Sharing surveillance data, and making it accessible to researchers and public health organizations, was one of the commitments made in 2016 by the more than 100 biopharmaceutical companies and trade organizations that signed on to the Davos Declaration on Antibiotic Resistance and later released the Industry Roadmap for Progress on Combating Antimicrobial Resistance.

    Pfizer, GSK, Shionogi, Johnson & Johnson, Merck, Paratek Pharmaceuticals, and Venatorx Pharmaceuticals are among the companies that have already committed to contributing their data to the AMR Register, which was developed by Vivli with a grant awarded by Wellcome.
    Jun 21 AMR Register press release