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SER-109, an Oral Microbiome Therapy for Recurrent Clostridioides difficile Infection.

Paul Feuerstadt1, Thomas J Louie1, Bret Lashner1

  • 1From Yale University School of Medicine, New Haven, and PACT Gastroenterology Center, Hamden - both in Connecticut (P.F.); the University of Calgary and Foothills Medical Centre, Calgary, AB, Canada (T.J.L.); Cleveland Clinic, Cleveland (B.L.); Seres Therapeutics, Cambridge, MA (E.E.L.W., L.D., J.A.B., C.B.F., M.-J.L., K.D.L., J.R.W., H.W., J.G.A., C.W.J.M., J.A.W., B.H.M., M.T., M.R.H., L.M.); Beaumont Hospital, Royal Oak, Royal Oak, and Oakland University William Beaumont School of Medicine, Rochester - both in Michigan (M.S.); Emory University, Atlanta (C.S.K.); the University of California, Davis, Davis (S.H.C.); the University at Buffalo and Veterans Affairs Western New York Healthcare System - both in Buffalo (C.S.B.); and Capital Digestive Care, Washington, DC (L.Y.K.).

The New England Journal of Medicine
|January 19, 2022
PubMed
Summary

SER-109, a microbiome therapeutic, significantly reduced recurrent Clostridioides difficile infection compared to placebo. This investigational treatment shows promise for patients with C. difficile infection by restoring the gut microbiome.

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Area of Science:

  • Microbiome therapeutics
  • Gastroenterology
  • Infectious diseases

Background:

  • Recurrent Clostridioides difficile infection (CDI) is often linked to a disrupted gut microbiome.
  • Current therapies do not fully address the underlying microbiome dysbiosis, which promotes C. difficile spore germination.
  • SER-109 is an investigational microbiome therapeutic utilizing purified Firmicutes spores to target recurrent CDI.

Purpose of the Study:

  • To evaluate the efficacy and safety of SER-109 compared to placebo in preventing recurrent CDI.
  • To assess SER-109's superiority in reducing the risk of C. difficile infection recurrence after standard antibiotic treatment.

Main Methods:

  • A Phase 3, double-blind, randomized, placebo-controlled trial was conducted.
  • 182 patients with a history of recurrent CDI received SER-109 or placebo post-antibiotic treatment.
  • Efficacy was measured by the reduction in CDI recurrence up to 8 weeks; safety, microbiome engraftment, and metabolite analyses were also performed.

Main Results:

  • SER-109 demonstrated a significantly lower recurrence rate (12%) compared to placebo (40%) (RR, 0.32; P<0.001).
  • Efficacy was consistent across different age groups and antibiotic treatments.
  • Adverse events were mild to moderate and similar between groups; SER-109 administration led to bile-acid profiles that inhibit C. difficile spore germination.

Conclusions:

  • Oral SER-109 is superior to placebo in decreasing the risk of recurrent C. difficile infection in patients with resolved symptoms after standard antibiotic therapy.
  • SER-109 exhibited a comparable safety profile to placebo.
  • The study supports SER-109 as a potential therapeutic option for recurrent CDI by modulating the gut microbiome.