The Roseville, Minn.-based company is developing a microbiome-based therapy to prevent recurrent Clostridium difficile infection. Its Microbiota Restoration Therapy, which is delivered via enema or a lyophilized, non-frozen oral capsule, is designed to supply a patient’s intestinal tract with an array of healthy, human-derived microbes.
The company’s most advanced candidate, RBX2660, is in Phase III development and, if approved, would be the first human microbiome product on the market. The FDA granted RBX2660 fast track, breakthrough therapy and orphan drug status.
“The scientific advances Rebiotix has made add significant strategic value to Ferring’s leadership in gastroenterology,” Michel Pettigrew, executive board president & COO of Ferring Pharmaceuticals, said in prepared remarks. “Therapies targeted towards the microbiome have the potential to transform healthcare. Together, we have a unique opportunity to help people living with debilitating and life-threatening conditions like Clostridium difficile infection.”
“Ferring shares our passion for understanding the role the microbiome plays in human health and has global capabilities that offer huge potential for the investigational therapies that we have in development,” founder, president & CEO of Rebiotix, Lee Jones, added. “Rebiotix was founded to revolutionize healthcare by harnessing the power of the human microbiome and this is a significant milestone in achieving that goal.”
More than 500,000 people are infected annually with C. diff., according to Rebiotix, and up to 30% of C. diff. patients experience more than one episode and need repeat treatment.
“The key is that there’s an underlying condition generally that’s caused them to be susceptible to C. diff. in the first place,” Jones told Drug Delivery Business News in an interview last year. “So what we’re doing with this disease is we’re dealing with the whole person.”