1341. Efficacy and Safety of RBX2660 for the Prevention of Recurrent Clostridium difficile Infection: Results of the PUNCH CD 2 Trial
Session: Poster Abstract Session: Clinical Trials
Friday, October 28, 2016
Room: Poster Hall
Posters
  • IDWeek 2016 Poster- PUNCH CD 2 Results-Version A-09-16-16-review.pdf (219.4 kB)
  • Background: Restoration of the intestinal microbiota is highly efficacious in preventing recurrent Clostridium difficileInfection (CDI). RBX2660 is a microbiota-based drug targeted at recurrent CDI. PUNCH CD 2, a multicenter, randomized, placebo-controlled, double-blinded Phase 2b trial was conducted to evaluate the safety and efficacy of RBX2660 including questions about dosing strategy and enema administration. 

    Methods: Patients were randomized to receive either: 2 doses of RBX2660 (Group A); 2 doses of placebo (Group B); or 1 dose of RBX2660 and 1 dose of placebo (Group C) via enema with doses 7 days apart. The primary end point was treatment success following 2 doses of RBX2660 compared with 2 doses of placebo. Success was defined as the absence of Clostridium difficile-associated diarrhea at 56 days following completion of the assigned treatment. Failures could receive up to 2 doses of open-label active treatment, 7 days apart. Secondary end points included overall efficacy and safety. Safety was assessed via a patient diary and clinical assessment.

    Results: A total of 150 patients at 21 sites in the US and Canada were enrolled in the study. Of these, 127 patients (Group A: n=41; Group B: n=44; Group C: n=42) were in the intention-to-treat population (mean age 61 years; 62.2% female). Efficacy for Group A was 61% vs. 45.5% for Group B, P= 0.152. Efficacy for Group C was 66.7% compared with Group B (45.5%), P=0.048. Efficacy of Group A and C (63.9%) vs. B (45.5%), P= 0.046.

    For patients who developed recurrent CDI after receipt of the study drug, open-label treatment success was: Group A (68.8%, 11/16); Group B (87.5%, 21/24); Group C (71.4%; 10/14) for an overall open label success rate of 77.8%.

    The combined efficacy for all patients who received at least 1 active treatment, including those who received open label RBX2660 after initial treatment failure, was 88.8% (n= 95).

    Adverse events (AEs) at 56 days were primarily gastrointestinal; there were no unanticipated AEs. There was no significant difference in the proportion of adverse or serious AEs among the treatment groups.

    Conclusion: In patients with recurrent CDI, a single dose of RBX2660 was superior to placebo, and showed equivalent efficacy as 2 doses. RBX2660 administered via enema was safe.

    Erik R. Dubberke, MD, MSPH, FIDSA, FSHEA, Washington University School of Medicine, St. Louis, MO, Christine Lee, MD, St. Joseph's Healthcare, Hamilton, ON, Canada, Robert Orenstein, DO, FIDSA, Infectious Diseases, Mayo Clinic Arizona, Phoenix, AZ, Sahil Khanna, MBBS, MS, Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, Gail Hecht, MD, Division of Gastroenterology and Nutrition, Loyola University Medical Center, Maywood, IL and Joseph Fraiz, MD, Infectious Disease of Indiana, Indianapolis, IN

    Disclosures:

    E. R. Dubberke, Rebiotix Inc.: Scientific Advisor , Consulting fee and Research support
    Merck: Consultant and Investigator , Consulting fee and Research grant
    Sanofi Pasteur: Consultant and Grant Investigator , Consulting fee and Grant recipient
    Summitt: Consultant , Consulting fee

    C. Lee, Rebiotix Inc.: Investigator and Scientific Advisor , Consulting fee and Research support

    R. Orenstein, Rebiotix Inc.: Investigator and Scientific Advisor , Consulting fee and Research support

    S. Khanna, Rebiotix Inc.: Investigator and Scientific Advisor , Consulting fee and Research support

    G. Hecht, Rebiotix Inc.: Investigator and Scientific Advisor , Consulting fee and Research support

    J. Fraiz, Rebiotix Inc.: Investigator , Research support

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