Phase 2 Study of VE303 for Prevention of Recurrent Clostridium Difficile Infection

CONSORTIUM is a randomized, double‐blind phase 2 study to evaluate safety, tolerability, PK/PD, and efficacy of VE303 in prevention of subsequent CDI‐associated diarrhea compared with placebo following completion of at least 1 successful course of standard‐of‐care (SOC) antibiotics. VE303 or placebo capsules will be taken orally for 14 days after completion of a course of standard of care antibiotics. The proportion of subjects experiencing a confirmed CDI recurrence, within 8 weeks after the first dose of study treatment, will be compared across the study arms to understand the effectiveness of VE303 in preventing rCDI. The study will enroll approximately 60 to 80 subjects with a prior history of CDI diarrhea or first occurrence of CDI diarrhea with a higher risk for recurrence. Subjects must also have a positive C. difficile stool sample and have responded to standard of care (SOC) antibiotic treatment.