FDA approves next phase of testing for microbiota restoration therapy
The FDA has approved an Investigational New Drug application for phase 2 testing of microbiota restoration therapy for Clostridium difficile infection, according to a press release.
Microbiota suspension RBX2660 (Rebiotix) restores the intestinal microbiome of patients with the introduction of live microbes to patients with C. difficile-associated diarrhea and is intended as a successor to fecal transplantation, itself an alternative to antibiotic treatment or surgery among patients with recurring disease.
The planned open-label, multicenter phase 2 study, according to the release, will evaluate the safety and efficacy of RBX2660. Cost-effectiveness of the treatment and its impact on patient quality of life also will be assessed.
“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,” Lee Jones, CEO of the company, said in the release. “We are working quickly to get the clinical trial running and to recruit patients.”
The treatment previously had received Fast Track designation from the FDA for this indication. The company also plans future clinical trials to assess the potential for other treatment indications for RBX2660.