Program Schedule

468
RBX2660 (microbiota suspension) for Recurrent C. difficile Infection: 60-Day Interim Analysis of the PUNCH-CD Phase 2 Safety Study

Session: Poster Abstract Session: Treatment of Antimicrobial Resistant Infections
Thursday, October 9, 2014
Room: The Pennsylvania Convention Center: IDExpo Hall BC
Posters
  • Number 468-IDWeek 2014 Poster.pdf (196.9 kB)
  • Background: There is increasing recognition that fecal transplant (FT) is an effective treatment for recurrent C. difficile infection (CDI). However, donor screening and product preparation can be burdensome. Despite promising efficacy results, safety data are limited. We report on a 60-day interim analysis of the first prospective open-label multi-center safety study of a next generation microbiota restoration therapy that has been standardized and manufactured under controlled conditions.

    Methods: Patients with recurrent CDI, defined as at least 3 CDI episodes or at least 2 severe episodes resulting in hospitalization, were enrolled. All patients received treatment with RBX2660 (microbiota suspension) administered via enema. A second treatment was permitted if CDI recurred in < 8 weeks after the first treatment. Follow-up was at 7, 30 and 60 days and 3 and 6 months after the last treatment. The primary objective was the product-related adverse events (AEs). A secondary objective was CDI resolution. 

    Results: Of the 40 patients enrolled at 11 centers in the US, 34 patients (mean age 66.8 years, 67.6% female) received at least one treatment. Thirty-one patients were included in a 60-day interim analysis. A total of 158 AEs were elicited in 29 patients. AEs were predominantly mild to moderate and included flatulence, belching, constipation, and occasional bouts of diarrhea. There were 9 serious AEs reported in 6 patients (3 recurrent CDI ≤ 8 weeks days post-treatment, all of which required hospitalization; 1 case of pneumonia; 1 pelvic fracture; 1 stab wound; 1 chronic obstructive pulmonary disease; 1 pulmonary edema and 1 respiratory failure). None of the serious AEs was related to RBX2660 or its administration. Efficacy of RBX2660 defined as the absence of CDI at 8 weeks after the last dose was 87.1%.

    Conclusion: RBX2660 was well-tolerated and demonstrated satisfactory safety in a 60-day interim analysis of the first prospective multi-center study of a next generation standardized, commercially prepared microbiota restoration therapy for recurrent CDI.

    Erik Dubberke, MD, MSPH, Division of Infectious Diseases, Washington University School of Medicine, St. Louis, MO, Robert Orenstein, DO, Infectious Diseases, Mayo Clinic Arizona, Phoenix, AZ, Paul Mariani, MD, Infectious Disease, Sanford Health, Fargo, ND, Kathleen Mullane, DO, FIDSA, University of Chicago Medicine, Chicago, IL and Mary Kay Sobcinski, RN, MHA, Rebiotix Inc, Roseville, MN

    Disclosures:

    E. Dubberke, Rebiotix: Consultant and Investigator, Consulting fee and Research support
    Sanofi Pasteur: Consultant and Investigator, Consulting fee and Grant recipient
    Merck: Consultant and Grant Investigator, Consulting fee and Research support
    Cubist: Consultant and Investigator, Consulting fee and Research support

    R. Orenstein, ReBiotix: Investigator and Scientific Advisor, Consulting fee and Research support
    Merck: Consultant and Investigator, Research support

    P. Mariani, Rebiotix: Investigator, Research support

    K. Mullane, Rebiotix: Research Contractor, Research support
    Astellas Pharma US Inc: Research Contractor and Speaker's Bureau, Research support
    Ason Pharmaceuticals: Research Contractor, Research support
    Chimerix: Research Contractor and Scientific Advisor, Research support
    Cubist / Optimer: Research Contractor and Scientific Advisor, Consulting fee and Research grant
    Merck Sharp & Dohme Corp: Research Contractor and Scientific Advisor, Consulting fee and Research support
    ViroPharma: Research Contractor, Research support
    Pfizer: Research Contractor, Research support

    M. K. Sobcinski, Rebiotix Inc: Employee, Salary

    Findings in the abstracts are embargoed until 12:01 a.m. EDT, Oct. 8th with the exception of research findings presented at the IDWeek press conferences.

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