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Data from 5 trials presented at ID Week 2021 are promising for the investigational biotherapeutic.
Historically speaking, rCDI occurs in 20-30% of patients, and the rates can increase with each ensuing episode. This reoccurrence has been difficult for patients who suffer from it causing it to have lingering effects and creating quality-of-life issues. From the clinical perspective, providers who are seeing these patients are looking for additional therapeutics and modalities to treat it.
From the 5 prospective trials presented by Ferring Pharmaceuticals and Rebiotix, a Ferring Company, which included 723 actively-treated participants, RBX2660 reduced the recurrence of CDI, with up to 78.9% remaining recurrence-free for eight weeks post treatment.
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%. 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.
“These data provide the totality of evidence culminating in over a decade’s worth of work that demonstrates a consistent efficacy profile for RBX2660, and importantly, a consistent safety profile across five prospective trials,” Lindy Bancke, PharmD, head of Clinical Development at Rebiotix, said. “They reinforce the enormous potential of microbiome-based therapeutics to transform the care of people suffering from rCDI.”
Banke’s presented the research, which was titled, Efficacy of Investigational Microbiota-Based Live Biotherapeutic RBX2660 in Individuals with Recurrent Clostridioides difficile Infection: Data from Five Prospective Clinical Studies, at IDWeek 2021.
RBX2660 is a potential first-in-class microbiota-based live biotherapeutic being studied to deliver a broad consortium of diverse microbes to the gut to reduce rCDI. RBX2660 has been granted Fast Track, Orphan, and Breakthrough Therapy designations from the Food and Drug Administration.
“Among 5 trials with consistent investigational product and clinical endpoints, RBX2660 consistently reduced rCDI recurrence, with a majority of treatment responders remaining CDI-free for at least 6 and up to 24 months,” Bancke reported.