Rebiotix is working closely with the U.S. FDA as it conducts an advanced clinical research program

Clinical Trials

Rebiotix conducted three clinical trials of lead Microbiota Restoration Therapy™ drug platform, RBX2660 for the prevention of recurrent Clostridium difficile (C. diff) infection, and is currently enrolling in a Phase 3 clinical trial, in conjunction with the U.S Food and Drug Administration under an Independent New Drug Application.

For currently enrolling clinical trials, go to clinicaltrials.gov.

Important milestones include:

PUNCH CD study: Phase 2 multicenter, open-label study. Reported in October 2014.
PUNCH CD 2: Phase 2B, prospective, multi-center randomized double-blind, placebo-controlled study of a microbiota-based drug. Results reported Q4 2016.
PUNCH Open Label: Phase 2 prospective, multi-center, open label controlled trial. Topline results reported April 2017.
Phase 3 PUNCH CD 3 – currently enrolling (click for details)

Special FDA designations for RBX2660:

Fast Track – May 2013
Orphan Drug – March 2014
Breakthrough Therapy – October 2015