VIDEO: CP101 increased microbiome diversity, reduced recurrent C. difficile
In this video, Jessica R. Allegretti, MD, MPH, discussed findings from the PRISM3 trial evaluating an investigational therapeutic for the prevention of recurrent Clostridioides difficile infection.
Allegretti, director of the fecal microbiota center at Brigham and Women’s Hospital, presented the trial findings at the ACG Annual Meeting.
In the phase 2 PRISM3 trial, patients with recurrent C. difficile were randomly assigned CP101 (Finch Therapeutics), an orally administered investigational microbiome therapeutic, or placebo. Results showed that CP101 met its primary efficacy endpoint of sustained clinical cure at 8 weeks.
Additionally, Allegretti and colleagues found that the increase in microbiome diversity conferred by CP101 significantly correlated with the clinical cure outcome.
“We know that recurrent C. difficile patients have low microbiome diversity, leading to that reduced colonization resistance, resulting in a favorable environment for the growth of C. difficile,” Allegretti said. “One time administration [of CP101] resulted in engraftment of CP101-associated taxa and subsequently rapid and sustained increase in microbiome diversity … and a significant and clinically meaningful reduction in recurrent C. difficile compared to placebo in the PRISM3 trial.”
Allegretti noted that the success of the trial has led to further study of CP101 in the phase 3 PRISM4 trial.
Reference
Allegretti JR, et al. 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).