Lack of Association with Patient Demographics and Outcomes in PUNCH CD 2, a Randomized Controlled Trial of RBX2660, a Microbiota-based Drug for Recurrent Clostridium difficile Infection

Gail Hecht, MD, Robert Orenstein, DO, Erik R.Dubberke, MD, MSPH, Christine Lee, MD, Sahil Khanna, MBBS, MS

Poster image of DDW 2017 presentation titled: Lack of Association with Patient Demographics and Outcomes in PUNCH CD 2, a Randomized Controlled Trial of RBX2660, a Microbiota-based Drug for Recurrent Clostridium difficile Infection

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Digestive Diseases Week
May 6-9, 2017, Chicago, IL

Background

  • Microbiota therapy is gaining acceptance for preventing recurrent Clostridium difficile infection (CDI).
  • RBX2660 is a microbiota-based drug derived from healthy human donors using a standardized, quality-controlled manufacturing process.
  • One dose of RBX2660 was demonstrated to be safe and effective for preventing rCDI in a randomized, double-blind, placebo controlled study (PUNCH CD 2; reported by Dubberke et al., ID Week, Oct 2016).
  • Recent microbiota-based trials suggested suggested that outcomes may correlate with patient demographics.
  • Key demographics of subjects treated in the PUNCH CD 2 trial were evaluated for impact on treatment.

Methods

  • A total of 133 patients with recurrent CDI were enrolled in the PUNCH CD 2 clinical trial at 21 sites in the USA and Canada (Trial #: NCT02299570).
  • Patients were randomized to receive: 2 doses of RBX2660 (Group A); 2 doses of placebo (Group B); or 1 dose of RBX2660 followed by 1 dose of placebo (Group C).
  • Therapies were administered via enema 7 days apart.
  • The first blinded treatment dose was administered 24-48 hours after completion of antibiotic treatment.
  • Success was defined as the absence of C. difficile-associated diarrhea at 8 weeks following completion of the last blinded treatment.
  • Demographic information was collected at the time of enrollment, with success and failure designations applied after the study blind was lifted.
  • Logistic regression was used to determine whether outcomes correlated with specific demographic characteristics.

RBX2660

  • One dose of RBX2660 contains 50 g of human stool per 150 mL of suspension in a single-dose ready-to-use enema bag.
  • Stored frozen at ≤−80°C at the manufacturer and shipped frozen to the site as needed in a temperature-controlled container.
  • Manufactured using standardized, quality-controlled processes with guaranteed minimum quantity of microbes.

Results

  • Logistic regression analysis was conducted with data from 127 patients treated in the blinded phase of the PUNCH CD 2 trial.
    (See tables in poster)

Conclusions

  • The efficacy outcome of RBX2660 did not depend on sex, age, region of the clinical trial center, or the antibiotic regimen completed prior to RBX2660 treatment.
  • The broad benefit of RBX2660 among patient demographics underscores its merit for further clinical evaluation for preventing rCDI.