vowst patient video | VOWST Purified Microbiome Therapeutic, Oral-mcdf

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STUDY DESIGN

ECOSPOR III
Multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in adults (≥18 years) with recurrent C. diff ^1-3
Primary Endpoint Recurrence at 8 weeks* Secondary Endpoints Adverse events within 24 weeks Recurrence at 4, 12, 24 weeks*
Recurrence confirmed with C. diff toxin test and ≥3 unformed bowel movements per day over 2 days*
10–21 days of vancomycin (125 mg QID) or fidaxomicin (200 mg BID)

ECOSPOR III efficacy endpoints based on intent-to-treat population.

Data were rounded to the nearest whole number for presentation.

STUDY DESIGN

ECOSPOR IV was an open-label, single arm study of 263 participants with ≥1 C. diff recurrences evaluating the safety of VOWST; the secondary endpoint was efficacy⁵

Limitations: open-label study design yields descriptive results limiting interpretations of efficacy and safety without a comparator

ECOSPOR IV
Multicenter, open-label, single-arm trial in adults (≥18 years) with recurrent C. diff ⁵
Primary Endpoint Adverse events within 24 weeks Secondary Endpoints Recurrence at 4, 8, 12, 24 weeks
Recurrence confirmed with C. diff toxin test or PCR and ≥3 unformed bowel movements per day over 2 days^*
10–42 days of vancomycin or 10–25 days of fidaxomicin

Toxin and PCR testing were utilized to determine initial eligibility. Recurrences while on study were confirmed by toxin testing to ensure study integrity.

^†25 placebo recipients and 4 VOWST recipients discontinued ECOSPOR III and enrolled in ECOSPOR IV after experiencing a C. Diff recurrence within 8 weeks.

Data were rounded to the nearest whole number for presentation.