Investigational therapeutic restores microbiome diversity in recurrent C. difficile
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LAS VEGAS — CP101, an investigational microbiome therapeutic, restored microbiome diversity and prompted a sustained clinical cure among patients with recurrent Clostridioides difficile infection, according to a presentation.
“Recurrent C. difficile infection is common following standard of care antibiotics and remains a significant burden on the health care system. Treatment guidelines recommend standard of care antibiotics; however, these therapies lead to significant microbiome disruptions which impairs colonization resistance,” Jessica R. Allegretti, MD, MPH, FACG, an attending gastroenterologist and director of the fecal transplant program for recurrent C. difficile at Brigham and Women’s Hospital and instructor of medicine at Harvard Medical School in Boston, said during her presentation at the ACG Annual Scientific Meeting. “Therefore, we desperately need new therapeutics to enhance microbiome recovery, measured by the increase in microbiome diversity, and enhance colonization resistance.”
PRISM3 was a double-blind, randomized, placebo-controlled trial that evaluated 198 patients from 51 sites across the United States who received standard of care antibiotics for recurrent C. difficile. Following a 2-day washout period, patients received either a one-time oral dose of CP101 (n = 101) or placebo (n = 96) without bowel preparation. The studied endpoint was sustained clinical cure at week 8; they measured intestinal microbiome diversity at baseline, week 1 and week 8 using 16S rRNA gene amplicon sequencing.
Compared with placebo, patients dosed with CP101 demonstrated an improvement in sustained clinical cure (74.5% vs. 61.5%; P = .0488) as well as higher alpha diversity which was rapid and sustained over time (week 1: P < .001; week 8: P < .0001). An increase in microbiome diversity at week 1 correlated with sustained clinical cure through week 8.
“The positive PRISM3 results are important and exciting because they bring us one step closer to the possibility of having a convenient, orally-administered therapeutic that can prevent recurrent C. difficile by restoring a diverse intestinal microbiome following the use of antibiotics,” Allegretti told Healio Gastroenterology. “While antibiotics are beneficial for treating an active C. difficile infection, they disrupt the intestinal microbiome and its ability to fight off the expansion of pathogens like C. difficile. You can think of the microbiome like an organ, and just like any other organ, if it gets damaged, you need a way to repair it and restore its function.”
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Allegretti JR, et al. Abstract: CP101, an investigational orally administered microbiome therapeutic, increases intestinal microbiome diversity and prevents recurrent c. difficile infection: Results from a randomized, placebo-controlled trial. Presented at: ACG Annual Scientific Meeting; Oct. 22-27, 2021; Las Vegas (hybrid meeting).
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