Rebiotix Inc. has enrolled the first patient in a phase 3 clinical trial to evaluate the efficacy and safety of RBX2660, a microbiota restoration therapy, for the prevention of recurrent Clostridium difficile infection, according to a recent press release.
“It’s exciting to see RBX2660 begin a Phase 3 trial for recurrent [C. difficile] infection,” Dale Gerding, MD, MACP, FIDSA, professor of medicine at Loyola University Chicago and chief medical officer at Rebiotix, said in the release. “This disease is especially challenging to treat and having this microbial therapy available to physicians could dramatically change how we manage the vexing problem of recurrences of this leading health care-associated infection.”
Developed as part of Rebiotix’s Microbiota Restoration Therapy (MRT) platform, RBX2660 is designed to offer a broad consortium of spore- and non-spore-forming microbes into a patient’s intestinal tract to restore a dysbiotic gut, according to the release. This randomized, double-blind, phase 3 trial will compare the proportion of patients with CDI who had successful treatment, defined as preventing infection for 8 weeks, on RBX2660 with the blinded placebo arm. The clinical trial will take place in the United States and Canada, and the finding will support a Biologics License Application with the FDA, according to the release.
This phase 3 trial follows the completion of three separate phase 2 studies that evaluated the safety and efficacy of RBX2660 for the prevention of recurrent CDI, said the press release. The drug has been tested in roughly 300 patients, some of whom were followed for 24 months after treatment, according to the release.
“Patients with debilitating, recurrent [C. difficile] need solutions,” Lee Jones, president and CEO of Rebiotix, said. “We plan to continue our strong momentum generated by our phase 2 results in this phase 3 trial as we seek to advance RBX2660 toward registration and potential approval so patients have an option for this unmet medical need.”
Gerding is chief medical officer at Rebiotix. Jones is President and CEO of Rebiotix.