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news.Rebiotix has completed patient enrollment in phase 2 trial of a microbiota restoration therapy (MRT) for the treatment of recurrent clostridium difficile (C. diff.) infection.
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A total of 117 patients were enrolled at over 20 sites in the US and Canada for the company’s PUNCH CD 2 multi-center, randomized, double-blind, placebo-controlled trial to evaluate RBX2660 to treat multi-recurrent C. diff. infection.
Several studies have demonstrated that most cases of C. diff. infection take place due to the use of antibiotics, which will disrupt normal microorganisms that reside in the gut, the company said.
Rebiotix said restoring the balance of microbes could play an important role to break the cycle of recurrence. MRT is the the company’s drug platform used to deliver live microbes into a sick patient’s intestinal tract for treating the disease.
The company randomized the patients enrolled in the phase 2B trial into three groups to assess safety and efficacy of RBX2660 compared to placebo.
Rebiotix CEO Lee Jones said: "The completed enrollment of this trial keeps Rebiotix at the forefront of microbiome research and eventual product commercialization.
"We continue to drive our key milestones with the goal of helping treat patients with recurrent C. diff."
Rebiotix is seeking to secure biologics license application approval from the US Food and Drug Administration to commercialize the microbiota-based drug.