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CIDRAP Stewardship/Resistance Scan: Oral microbiome therapy for C diff; Funding for new TB treatments

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  • CIDRAP Stewardship/Resistance Scan: Oral microbiome therapy for C diff; Funding for new TB treatments


    Stewardship / Resistance Scan for Jan 21, 2022
    Oral microbiome therapy for C diff; Funding for new TB treatments
    Filed Under:
    Antimicrobial Stewardship; Clostridium difficile; Tuberculosis

    Phase 3 trial finds oral microbiome therapy cuts risk of recurrent C diff

    In a phase 3 trial, an investigational oral microbiome therapy was superior to placebo in reducing the risk of recurrent Clostridioides difficile infection, researchers reported yesterday in the New England Journal of Medicine.
    The double-blind, randomized trial involved patients who had had three or more episodes of C difficile infection within 12 months and had resolution of symptoms following standard-of-care antibiotic therapy. From July 2017 through September 2020, the patients were enrolled and randomly assigned 1:1 to receive SER-109, a therapeutic composed of live purified Firmicutes bacterial spores developed by Seres Therapeutics (which funded the study), or placebo once daily for 3 days. The primary efficacy objective was to show the superiority of SER-109 over placebo in reducing the risk of C difficile recurrence over 8 weeks.
    Of the 281 patients screened for the trial, 182 were enrolled, and 149 completed 8 weeks of follow-up. The percentage of patients with recurrence was significantly lower in in the SER-109 group than in the placebo group (12% and 40%, respectively; relative risk, 0.32; 95% confidence interval [CI], 0.18 to 0.58; P < 0.001).
    SER-109 also led to less frequent recurrence than placebo in analyses stratified according to age (relative risk, 0.24 [95% CI, 0.07 to 0.78] for patients younger than 65 years of age and 0.36 [95% CI, 0.18 to 0.72] for those 65 years and older) and antibiotic received (relative risk, 0.41 [95% CI, 0.22 to 0.79] with vancomycin and 0.09 [95% CI, 0.01 to 0.63] with fidaxomicin).
    Most adverse events were mild to moderate and were gastrointestinal in nature, with similar numbers in the two groups. SER-109 dose species were detected as early as week 1 and were associated with bile-acid profiles that are known to inhibit C difficile spore germination.
    "In patients with recurrent C. difficile infection, achievement of a sustained clinical response can be made more likely with a two-pronged treatment paradigm of antibiotics followed by a microbiome therapeutic," the study authors wrote. "Insights into the pharmacologic properties of this oral microbiome therapeutic have implications not only for treatment of recurrent C. difficile infection but also for other diseases with pathogenesis that may be rooted in microbiome disruption."
    Jan 20 N Engl J Med abstract

    TB Alliance receives $30 million from USAID for new TB treatments

    The nonprofit TB Alliance announced yesterday that it has received $30 million in funding from the US Agency for International Development (USAID) to develop new treatments for tuberculosis (TB) and optimize current treatments so that they can be used in children.
    TB Alliance will also use the funding, which will be administered over 5 years, to strengthen health systems in high-TB-burden countries so that all TB patients can get proper treatment.
    A recent report from the World Health Organization found that the COVID-19 pandemic has reversed years of progress against TB, and that 1.5 million people died from TB in 2020—up from 1.4 million in 2019. It was the first global increase in TB deaths in more than a decade.
    "While the world was focused on the COVID-19 pandemic, the TB pandemic tightened its grip on the most impoverished parts of the world," TB Alliance CEO and President Mel Spigelman, MD, said in a press release. "This is the danger we face in letting older diseases linger instead of eradicating them. We are grateful for the support and collaboration of partners like USAID; only by working together can we make up the ground that has been lost in the past two years."
    TB Alliance has played a critical role in advocating for and developing new TB treatments, including pretomanid, a key new element of the shorter treatment regimen for multidrug-resistant TB. The group says its drug development work will continue to focus on finding new drug candidates and developing child-friendly formulations of current drugs.
    Jan 20 TB Alliance press release

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