Results: Among the 132 PRISM-EXT participants, the proportion without CDI recurrence following administration of SOC antibiotics and CP101 was 80.3% through Week 8 and 78.8% through Week 24. No treatment-related serious adverse events were reported. Microbiome analysis showed that diversity significantly increased from baseline through Week 8 (p, 0.0001) and Week 24 (p, 0.0001, Fig 1A). Participant microbiomes became more similar to CP101 after treatment compared to baseline. Higher engraftment of CP101-associated taxa and improvement in diversity were both associated with prevention of CDI recurrence at Week 8 (Fig 1B).
Conclusion:The majority of PRISM-EXT participants treated with CP101 had no CDI recurrence through Week 8 and 24. Microbiome analysis suggests that treatment with CP101 led to engraftment and an increase in gut microbiome diversity, both important factors that were associated with the prevention of recurrence.
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