Microbiome drug reduces recurrent CDI
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The investigational oral microbiome drug CP101 helped prevent recurrence of Clostridioides difficile infection across a broad population of patients, according to research presented at UEG Week Virtual.
In her presentation, Jessica Allegretti, MD, from Brigham & Women’s Hospital, said recurrent CDI is associated with loss of microbiome diversity and impaired colonization resistance. CP101 (Finch Therapeutics) was designed to prevent that.
“This oral agent was developed to restore a complete microbiome community with a systems biology approach directly mimicking underlying biology,” she said. “It is also designed for infective intestinal delivery with no bowel prep required to prevent recurrent C. diff by restoring microbiome diversity.”
In the PRISM3 trial, researchers recruited patients aged at least 65 years with first CDI recurrence who were at high risk for further recurrence, or patients who had two or more recurrences. After they completed the most recent course of CDI antibiotics, they randomly assigned patients to receive either CP101 (n = 102) or placebo (n = 96). The primary endpoint of the study was sustained clinical cure, defined as an absence of CDI recurrence through 8 weeks after dosing.
Following standard of care antibiotics, the proportion of sustained clinical cure was higher in the CP101 group compared with placebo (74.5% vs. 61.5%; P = .0488). In a per protocol analysis prior to unblinding (n = 166), researchers found that the proportion of sustained cure was also higher in the CP101 group (73.5% vs. 55.4%; P = .015). A time-to-event analysis also favored the drug over placebo (P = .0139).
Additionally, CP101 helped increase microbiome diversity and was well tolerated by patients.
“[This study] was the first positive, pivotal trial that has included patients experiencing their first CDI recurrence,” Allegretti said. “It is also the first positive, pivotal trial of an oral product including any guideline-approved diagnostic method, which really does increase this study’s generalizability.”
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