- Ferring Pharmaceuticals Inc. has snapped up Rebiotix Inc. in a deal to beef up the Swiss pharma's gastroenterology pipeline and access to potential microbiome treatments.
- Rebiotix's lead product, RBX2660, is in Phase 3 development for the prevention of recurrent Clostridium difficile infections. The agent has Fast Track, Breakthrough Therapy and Orphan Drug designations from the Food and Drug Administration and is eligible for expedited review.
- The financial terms of the deal have not been disclosed.
Recurrent C. diff. infections pose a real challenge to the field of medicine — the World Health Organization (WHO) has classified the bacteria as a priority pathogen. According to WHO's May 2017 analysis of antibacterial products in Phase 1 to Phase 3 development, there were nine antibiotics and biologics in the pipeline, with only one in Phase 3 development. The analysis does not include products that target the microbiome, and demonstrates a huge gap in alternative approaches and strategies to prevent, rather than simply treat, the infection.
The failure of Seres Therapeutics Inc.'s pioneering microbiome product in Phase 2 back in 2016 spooked the industry over the potential of microbiota, but the deal between Ferring and Rebiotix signals that the interest is resurging. While the terms of the deal haven't been disclosed, the benefits for both sides are clear. Ferring gains a foothold in the increasingly exciting and clinically accepted field of the microbiome, and Rebiotix, which was only founded in 2011, gets a worldwide audience for its potential therapeutics.
"Rebiotix was founded to revolutionize healthcare by harnessing the power of the human microbiome and this is a significant milestone in achieving that goal," said Lee Jones, cofounder and CEO of Rebiotix, in a statement.
Rebiotix's RBX2660, a non-antibiotic approach to the prevention of recurrent C. diff. infection, has potential to be the first human microbiome product approved anywhere in the world. In the dramatically-named PUNCH Phase 2 study, two doses of RBX2660, a broad spectrum suspension of "good" microbes, prevented recurrences of CDI in 78.8% of patients, compared with 51.8% of historical controls treated with antibiotics.
RBX2660 is the lead product arising from Rebiotix's Microbiota Restoration Therapy (MRT) drug platform, which delivers live, human-derived microbes into the gastrointestinal tract; others include RBX7455, a non-frozen, lyophilized oral capsule formulation, in development for the prevention of recurrent CDI. As RBX2660 is supplied frozen and then administered as an enema after thawing, RBX7455 will be easier to store and administer, and may be preferred by both healthcare professionals and patients.