Recurrent CDI: microbiota-based drug shows partial efficacy in phase 2b trial

  • Clin Infect Dis

  • Miriam Davis, PhD
  • Clinical Essentials
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 Takeaway

  • For patients with recurrent Clostridium difficile infections (rCDIs), 1 but not 2 doses of RBX2660, a microbiota-based drug, prevented rCDI for 8 weeks after treatment.

Why this matters

  • If further research proves successful, RBX2660 may be first in a new class of treatment options for rCDIs.

Study design

  • Randomized, placebo-controlled, double-blinded, multicenter trial of 127 patients with rCDI assigned to receive: 2 doses of RBX2660, each in a 150 mL suspension containing ≥10live organisms/mL in a single-dose ready-to-use enema bag (group A), 2 doses of placebo (group B), or 1 dose of RBX2660 followed by 1 dose of placebo (group C).
  • Efficacy was defined as prevention of rCDI for 8 weeks after treatment.
  • The primary outcome was efficacy for group A vs group B.
  • Funding: Rebiotix Inc.

Key results

  • Efficacy was achieved by 61% of group A, 45% of group B, and 67% of group C, but the primary outcome was not met (group A vs B; P=.152).
  • Group C (1 dose of RBX2660) had greater efficacy than group B (placebo) (P=.049).
  • There was no difference among groups in adverse or serious adverse events, most commonly gastrointestinal disorders, infections, and nervous system disorders.

Limitations

  • Small sample size.