A phase 2b multicenter, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of a microbiota restoration therapy for multi-recurrent Clostridium difficile infection finalized enrollment, the manufacturer announced.
RBX2660 is Rebiotix’s lead candidate within microbiota restoration therapy, or MRT, the company’s drug platform for delivering live microbes into the intestinal tract, according to the press release. RBX2660 has previously been granted orphan drug status, fast track status and breakthrough therapy designation by the FDA.
The FDA oversees the PUNCH CD clinical program, which aims to evaluate the safety and efficacy of RBX2660 for recurrent C. difficile infection “with the goal of obtaining Biologics License Application approval to commercialize the microbiota-based drug.”
The current trial has enrolled 117 patients from more than 20 U.S. and Canadian sites, making PUNCH CD 2 the largest randomized controlled trial of an MRT for recurrent C. difficile infection to date, according to the press release.
“There is significant promise in MRT and this milestone exemplifies Rebiotix’s leadership position in realizing the potential in this therapy,” Rebiotix CEO Lee Jones said in the press release. “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.”
Disclosures: Jones reports he is an employee of Rebiotix.