Investigators have completed enrollment in a phase 3 trial set to investigate RBX2660, a therapy that uses the gut microbiota to treat Clostridioides difficile infection, according to a press release issued by Rebiotix, the manufacturer.
The company said this is the first microbiota-based formulation to reach phase 3 in the United States and Canada.
“Microbiota-based therapies have shown tremendous potential as an innovative, non-antibiotic therapy, starting with C. diff,” Rebiotix founder and CEO Lee Jones said in the press release. The completion of enrollment of this trial is a critical next step in making microbiota-based products accessible to patients - we are excited about this important milestone and look forward to sharing results later this year.”
RBX2660 was developed using the company’s microbiota-based MRT drug platform. A previous phase 2 trial found the drug was effective for the prevention of recurrent CDI.
The company plans to present clinical data to the FDA in a biological license application and believes RBX2660 will be the first microbiota-based therapy to obtain regulatory approval in the U.S.
Disclosure: Jones is employed by Rebiotix.