Rebiotix is on the forefront of an exciting potential medical breakthrough
Harnessing the Power of the Human Microbiome
Rebiotix Inc., a Ferring Company, is a clinical stage biotechnology company founded to revolutionize the treatment of debilitating diseases by harnessing the power of the human microbiome.
The company is on the forefront of an exciting potential medical breakthrough with our MRT™ drug platform. The MRT drug platform is leveraged to develop formulations consisting of live microbes, which are evaluated through our clinical program for the formulation’s ability to address challenging diseases.
Rebiotix looks to deliver on the promise of restoring the gut microbiota via standardized and stabilized investigational drugs that have been developed and tested under the auspices of a regulatory authority.
Video play time is 1:00 minute.
Key Milestones in Harnessing the Power of the Human Microbiome
2011
- Rebiotix was founded
2012
- Pre-Investigational New Drug (IND) meeting with FDA for RBX2660
2013
- FDA IND granted
- Fast Track designation granted
- PUNCH CD Phase 2 trial enrolled for RBX2660 to treat recurrent Clostridium difficile
2014
- FDA Orphan Drug designation granted
- Results of PUNCH CD announced
- PUNCH CD 2 (phase 2b) trial initiated
- Development of oral formulation, RBX7455, started
2015
- PUNCH CD 2 enrollment for RBX2660 completed
- FDA Breakthrough Therapy Status granted for RBX2660
- Oral formulation Drug Master File (DMF) filed with FDA
2016
- PUNCH CD 2 Randomized Double Blind Placebo Control Study results confirming Phase 2 data
- RBX7455 Non-Frozen Capsule feasibility study initiated
2017
- Rebiotix Reports Positive Top Line Data from Open-Label Phase 2 Trial of RBX2660 in Recurrent Clostridium difficile
- Phase 3 PUNCH CD3 initiated Q3 2017
2018
2019
- Phase 3 Open Label PUNCH CD3-OLS Initiated Q2 2019
2020
2021
- Phase 3 PUNCH CD3 Data presented at DDW 2021
- Phase 3 Open Label PUNCH CD3-OLS Interim Results presented at DDW 2021