Rebiotix Inc., a biotechnology company based in Roseville, MN, announced that the U.S. FDA has designated its lead Microbiota Restoration Therapy (MRT) RBX2660 as a Breakthrough Therapy for the treatment of recurrent Clostridium difficile (C diff) infection. C diff infection is a challenging to treat gastrointestinal (GI) infection that causes 29,000 deaths in the U.S annually. MRT is the Rebiotix drug platform for delivering healthy, live, human-derived microbes into a sick patient’s intestinal tract to treat disease.
Most cases of C diff infection occur after the normal microorganisms that reside in the gut have been disrupted by antibiotic use. Restoring the balance of microbes is thought to be key to breaking the cycle of recurrence. Currently, 20-30% of patients with C diff go on to experience more than one episode of the disease, which is known as recurrent C diff infection. Recurrent C diff infection is especially challenging to treat as, to date, there are no approved drugs to treat patients with two or more recurrences.