VIDEO: ‘Distinctive shift’ in gut microbiota after Rebyota treatment for C. difficile
CHICAGO — In a Healio video exclusive, Ken Blount, PhD, discusses successful restoration of gut microbiota and clonal engraftment as soon as 1 week after treatment with Rebyota in those with recurrent Clostridioides difficile infection.
Blount and colleagues sought to quantify and define clonal engraftment and durable microbiome compositional changes with FDA-approved Rebyota (fecal microbiota, live-jslm/RBX2660, Ferring Pharmaceuticals) in the phase 3 PUNCH CD3 trial, which enrolled adult patients with at least one recurrent episode of C. difficile infection.
Following standard of care antibiotic treatment, patients received a single blinded dose of RBX2660 or placebo. Researchers defined treatment success as remaining free from infection recurrence for 8 weeks after treatment.
“What we observed was a distinctive shift from before to after Rebyota treatment,” Blount, chief scientific officer at Rebiotix, a Ferring company, and vice president of microbiome research at Ferring Pharmaceuticals, said. “Specifically, prior to Rebyota, most of the patients had a preponderance or a high abundance of bacteria not normally found in a healthy gut, specifically Gammaproteobacteria bacilli, whereas the normally predominant taxa, Bacteroidia and Clostridium, were decreased in those patients prior to Rebyota the treatment.”
Researchers also observed a median of at least 10 instances of clonal engraftment per patient 1 week after treatment, which persisted through the 6-month follow-up. Further, Bacteroidia and Clostridia taxonomic classes had highest engraftment effectiveness, Blount said.
In addition, results from a control analysis, which paired metagenomic species from RBX2660-treated patients with placebo-treated patients, showed no significant clonal engraftment among those treated with placebo.
“We would not expect to observe any engraftment in a placebo-treated patient, because they weren’t administered any species,” Blount said. “That is exactly what we found — zero engraftment.”
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Blount K, et al. Abstract 697: Significant and durable microbiome compositional changes and clonal engraftment in a phase 3 trial of RBX2660 for recurrent Clostridioides difficile infection. Presented at: Digestive Disease Week; May 6-9, 2023; Chicago (hybrid).
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