Rebiotix Inc., a Ferring Company, is working closely with the U.S. FDA as it conducts an advanced clinical research program
Clinical Trials
Rebiotix Inc., a Ferring Company, has conducted several clinical trials with it’s lead microbiota-based product in the MRT™ drug platform, RBX2660 for the prevention of recurrent Clostridioides difficile (C. diff) infection. The trials were conducted under the U.S Food and Drug Administration’s Investigational New Drug (IND) Application, as well as HealthCanada’s Clinical Trial Application (CTA) regulations.
For currently enrolling clinical trials, go to clinicaltrials.gov.
Important milestones include:
- PUNCH CD study: Phase 2 multicenter, open-label study.
- PUNCH CD 2: Phase 2B, prospective, multi-center randomized double-blind, placebo-controlled study of a microbiota-based drug.
- PUNCH Open Label: Phase 2 prospective, multi-center, open label controlled trial.
- Phase 3 PUNCH CD 3 – completes enrollment (click for details).
- Acquired by Ferring Pharmaceuticals in April 2018.
- Rebiotix Announces World’s First with Positive Preliminary Pivotal Phase 3 Data for Investigational Microbiome-based Therapy RBX2660.
Special FDA designations for RBX2660:
- Fast Track – May 2013
- Orphan Drug – March 2014
- Breakthrough Therapy – October 2015