Ferring Presents Complete Data across Five RBX2660 Trials Demonstrating Consistent and Durable Efficacy in Recurrent C. Difficile Infection, as Well as Multiple Analyses Demonstrating Positive Shifts in Microbiome Properties from Kulr8
October 14, 2021
Ferring Pharmaceuticals and Rebiotix, a Ferring Company, today announced final results of an analysis from five prospective trials of its investigational microbiota-based live biotherapeutic, RBX2660, for the reduction of recurrent C. difficile infection (rCDI). The abstract, presented at IDWeek 2021, represents the first time these data are showcased together, and is one of only four abstracts to receive the Program Committee Choice award for outstanding scientific research.
“For years, people with recurrent C. difficile infection haven’t had an available, standardized treatment option to break the cycle of recurrence or clinically address the health of their gut microbiome composition that puts them at risk for this highly communicable disease, and they still do not,” said Teena Chopra, MD, MPH, Professor of Medicine, Division of Infectious Disease, Wayne State University School of Medicine. “The important data from the Ferring microbiome-based biotherapeutic trials provide a significant milestone for the C. difficile community to hopefully one day have an improved treatment option for patients suffering from this disease.”
Across the five prospective trials, which included 723 actively-treated participants, RBX2660 consistently reduced the recurrence of CDI, with up to 78.9% remaining recurrence-free for eight weeks post treatment (defined as treatment success). Among participants who did not respond to initial treatment, an optional additional treatment course was administered, resulting in overall rates of treatment success of up to 84.4%. Notably, most primary responders remained CDI-free for six months and up to two years, with a sustained clinical response success rate of up to 92.1% in the Phase 3 program. …
