Results of the Phase 2 PUNCH™ CD Safety Study of RBX2660 (microbiota suspension) for Recurrent C. difficile Infection

Erik Dubberke, MD, MSPH, Washington University School of Medicine, St. Louis, MO; Robert Orenstein, DO, Mayo Clinic Arizona, Phoenix, AZ; Kathleen Mullane, DO, PharmD, University of Chicago Medicine, Chicago, IL; Robert Hardi, MD, Capital Digestive Care, Chevy Chase, MD; Arnab Ray, MD, Ochsner Clinic, New Orleans, LA; Mary Kay Sobcinski, RN, MHA, Rebiotix Inc., Roseville, MN

Results of the Phase 2 PUNCH™ CD Safety Study of RBX2660 (microbiota suspension) for Recurrent C. difficile Infection

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European Congress of Clinical Microbiology and Infectious Diseases
April 25-28, 2015, Copenhagen, Denmark

Background

  • Clostridium difficile infection (CDI) places an increasingly large burden on healthcare systems worldwide in terms of morbidity, mortality and costs.1,2
  • Approximately 25% of patients suffer from recurrence of disease, and recurrent CDI is especially challenging to treat.3
  • There is increasing recognition that fecal microbiota transplantation (FMT) is an effective treatment for recurrent CDI.4-6
  • A systematic evaluation of the safety of FMT has not been been done; concerns remain.

References

  1. Lessa FC, Mu Y, Bamberg WM, et al. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015;372:825-834.
  2. Bauer MP, Notermans DW, van Benthem BHB, et al, for the ECDIS Study Group. Clostridium difficile infection in Europe: a hospital based survey. Lancet 2011; 377: 63–73.
  3. Kelly CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012;18 (Suppl 6):21-7.
  4. van Nood E, Vrieze A, Nieuwdorp M, et al. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013;368:407-15.
  5. Lee CH, Belanger JE, Kassam Z.. The outcome and long-term follow-up of 94 patients with recurrent and refractory Clostridium difficile infection using single to multiple fecal microbiota transplantation via retention enema. Eur J Clin Microbiol Infect Dis. 2014;33(8):1425-8.
  6. Patel NC1, Griesbach CL, DiBaise JK, Orenstein R. Fecal microbiota transplant for recurrent Clostridium difficile infection: Mayo Clinic in Arizona experience. Mayo Clin Proc. 2013 Aug;88(8):799-805.