Rebiotix Inc. has announced it has received FDA approval on its Investigational New Drug (IND) application to begin a Phase 2 clinical study of a treatment of recurrent Clostridium difficile infection (CDI).
The treatment, RBX2660, is a “preparation containing live microbes designed to rebuild a healthy intestinal micro biome.” If successful, the treatment will become the first FDA-approved drug based on the human microbiome, according to the press release.
“IND approval represents a significant milestone for Rebiotix, and continues our progress toward developing and commercializing a new therapy to treat patients with this debilitating and potentially life-threatening disease,” said Rebiotix CEO Lee Jones. “We are working quickly to get the clinical trial running and to recruit patients.” Jones also noted that Rebiotix is committed to conducting a full program of clinical trials to expand treatment options for recurrent CDI and to explore additional indications for its microbiota restoration therapy.
Click here to read the Rebiotix press release.
Photo: C. difficile bacteria. Photo credit: CDC