Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI

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dc.contributor.authorKraft, Colleen S.
dc.contributor.authorSims, Matthew
dc.contributor.authorSilverman, Michael
dc.contributor.authorLouie, Thomas J.
dc.contributor.authorFeuerstadt, Paul
dc.contributor.authorHuang, Edward S.
dc.contributor.authorKhanna, Sahil
dc.contributor.authorBerenson, Charles S.
dc.contributor.authorWang, Elaine E. L.
dc.contributor.authorCohen, Stuart H.
dc.contributor.authorKorman, Louis
dc.contributor.authorLee, Christine
dc.contributor.authorKelly, Colleen R.
dc.contributor.authorOdio, Alberto
dc.contributor.authorCook, Paul P.
dc.contributor.authorLashner, Bret
dc.contributor.authorRamesh, Mayur
dc.contributor.authorKumar, Princy
dc.contributor.authorDe, Ananya
dc.contributor.authorMemisoglu, Asli
dc.contributor.authorLombardi, David A.
dc.contributor.authorHasson, Brooke R.
dc.contributor.authorMcGovern, Barbara H.
dc.contributor.authorvon Moltke, Lisa
dc.contributor.authorPardi, Darrell S.
dc.date.accessioned2024-06-30T00:03:43Z
dc.date.available2024-06-30T00:03:43Z
dc.date.issued2024-06-28
dc.date.updated2024-06-30T00:03:43Z
dc.description.abstractAbstract 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.
dc.identifier.urihttps://doi.org/10.1007/s40121-024-01007-z
dc.identifier.urihttps://hdl.handle.net/1880/119075
dc.language.rfc3066en
dc.rights.holderThe Author(s)
dc.titleIntegrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI
dc.typeJournal Article
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