About Clostridioides difficile Infection

With about 29,000 patient deaths a year, the U.S. Centers for Disease Control has termed Clostridioides difficile (C. diff.) infection an urgent public health threat.¹ Although estimates vary, there are between 500,000 and 700,00 cases of C. diff. infection in the U.S. alone.

Risk Factors

Antibiotic use
Older age (> 65 years)
Exposure to health care facilities
Severe underlying disease
Compromised immune response

The Problem of Recurrence

Antibiotic therapy is the standard treatment following an initial diagnosis of C. diff. However, approximately 25% of patients initially cured will experience a recurrence. Each recurrence predisposes to further recurrence. After two or more episodes of recurrence, the risk of subsequent recurrence may reach 65%.²

Breaking the Cycle of Recurrence

In healthy individuals, the microbial ecology of the gut microbiota prevents the development of symptomatic C. diff. infection. However, antibiotics disturb this complex community, allowing C. diff. infection to repeatedly colonize the large intestine of those most at risk of infection. To break the cycle of recurrence, a different approach to standard of care (antibiotics) alone may be needed.³

The Potential of Microbiota-Based Therapies in the MRT™ Drug Platform

The Rebiotix MRT™ drug platform presents the possibility to change the therapeutic landscape for recurrent C. diff. infection. Rather than utilizing antibiotics to address the illness, our technology introduces a broad consortium of live, diverse microbes to a patient’s intestinal tract.

We have extensively researched the potential of our microbiota-based live biotherapeutic, RBX2660, to reduce the recurrence of C. difficile infection. To date, we have completed five controlled trials, including two randomized, double-blind, placebo controlled trials, as well as an open-label study including patients that are more reflective of those seen in real-world practice. These six programs encompass more than 1000 participants. An oral formulation for recurrent C. diff. infection prevention and additional MRT™ drug platform drugs are under development. Beyond our formulation research, you can learn more about the microbiome’s influence on recurrent C. difficile infection through Ferring’s Power of the Microbiome website.

The MRT™ Platform’s Fit into Ferring

In April of 2018, Rebiotix was acquired by Ferring Pharmaceuticals, a Swiss-based specialty pharmaceutical company specializing in reproductive medicine/maternal health, gastroenterology, urology, and uro-oncology. Through the acquisition, Rebiotix became part of the Ferring Family, a global team able to distribute to 110 countries, with research and manufacturing spread world-wide. The microbiome expertise of the Rebiotix team vastly extended Ferring’s commitment to the microbiome, broadening a research portfolio established by Ferring in 2008.

We are proud to now be part of Ferring Pharmaceuticals. As part of this global team, we will continue to bring our expertise in microbiome-based research and therapeutics development forward to help people live better lives. We believe the MRT Platform and the learnings from our advanced development program will pave the way for future applications of microbiota-based live biotherapeutics in multiple indications; through Ferring, these future applications may soon reach patients and physicians world-wide.

Special FDA Designations for RBX2660:

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

References

Antibiotic resistance threats in the United States, 2019. 2019. doi:10.15620/cdc:82532
Kelly CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012; 18 (Suppl. 6): 21–27.
Theriot CM, Young VB. Interactions Between the Gastrointestinal Microbiome and Clostridium difficile. Annu Rev Microbiol. 2015;69:445-61.