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Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI
Colleen S Kraft1, Matthew Sims2,3, Michael Silverman4
1Department of Pathology and Laboratory Medicine, Division of Infectious Diseases, Emory University, Atlanta, GA, USA.
Introduction:
Recurrent Clostridioides difficile infection (rCDI) often occurs after standard-of-care antibiotics. VOWST oral spores (VOS, previously SER-109), an FDA-approved orally administered microbiome therapeutic, is indicated to prevent rCDI following antibiotics for rCDI.
Objective, Design, And Patients:
To evaluate safety and efficacy of VOS from two phase 3 trials, (randomized, placebo-controlled [ECOSPOR III: NCT03183128] and open-label, single arm [ECOSPOR IV: NCT03183141]) of 349 adults with rCDI and prevalent comorbidities.
Methods:
VOS or placebo [ECOSPOR III only] (4 capsules once daily for 3 days). Integrated analysis of treatment-emergent adverse events (TEAEs) collected through week 8; serious TEAEs and TEAEs of special interest collected through week 24; and rates of rCDI (toxin-positive diarrhea requiring treatment) evaluated through weeks 8 and 24.
Results:
TEAEs were mostly mild or moderate and gastrointestinal. Most common treatment-related TEAEs were flatulence, abdominal pain and distension, fatigue, and diarrhea. There were 11 deaths (3.2%) and 48 patients (13.8%) with serious TEAEs, none treatment-related. The rCDI rate through week 8 was 9.5% (95% CI 6.6-13.0) and remained low through 24 weeks (15.2%; 95% CI 11.6-19.4). Safety and rCDI rates were consistent across subgroups including age, renal impairment/failure, diabetes, and immunocompromise/immunosuppression.
Conclusions:
VOS was well tolerated and rates of rCDI remained low through week 24 including in those with comorbidities. These data support the potential benefit of VOS following antibiotics to prevent recurrence in high-risk patients.
Trial Registration:
ClinicalTrials.gov identifier, NCT03183128 and NCT03183141.
Insights
Vowst oral spores (VOS) effectively prevented recurrent Clostridioides difficile infection (rCDI) in adults with comorbidities. This microbiome therapeutic demonstrated good tolerability and sustained low rCDI rates through 24 weeks.
Area of Science:
- Microbiome therapeutics
- Gastroenterology
- Infectious diseases
Background:
- Recurrent Clostridioides difficile infection (rCDI) is a significant clinical challenge, often following standard antibiotic treatments.
- Vowst oral spores (VOS), an FDA-approved microbiome therapeutic, is designed to prevent rCDI after antibiotic use.
Purpose of the Study:
- To evaluate the safety and efficacy of VOS in preventing rCDI.
- Assess VOS in adults with rCDI and common comorbidities through integrated Phase 3 trials.
Main Methods:
- Two Phase 3 trials (ECOSPOR III and ECOSPOR IV) involving 349 adults with rCDI.
- Integrated analysis of treatment-emergent adverse events (TEAEs) up to week 24 and rCDI rates up to week 24.
Main Results:
- VOS was well-tolerated, with mostly mild to moderate gastrointestinal TEAEs.
- The rCDI rate was 9.5% at week 8 and 15.2% at week 24, remaining low across subgroups.
- No treatment-related serious TEAEs or deaths were reported.
Conclusions:
- VOS demonstrated a favorable safety profile and effectively reduced rCDI rates through 24 weeks.
- The findings support VOS as a beneficial option for preventing rCDI in high-risk patients with comorbidities.
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