Rebiotix says lead product to treat gastrointestinal infection scores Breakthrough Therapy designation from US FDA

USA-based Rebiotix Inc said its lead product to treat gastrointestinal (GI) infection has been granted Breakthrough Therapy designation by the US Food and Drug Administration.

Rebiotix chief executive Lee Jones said: "The development of RBX2660 represents our commitment to harnessing the microbiome to develop therapies for debilitating and sometimes fatal disease for which there is currently no FDA-approved alternative. The breakthrough therapy designation marks the third regulatory milestone for our lead product, RBX2660, in the past two years, and reinforces our leading efforts that have brought us to the cusp of delivering a revolutionary and validated treatment to patients living with recurrent C diff."

The clinical stage biotechnology company said its microbiota restoration therapy is in trial stage. Recurrent clostridium difficile or gastrointestinal infection causes 29,000 deaths in the US annually.