Scientific Poster Session IV - Original Research

Original Research
  Tuesday, November 14, 2023
  08:30 AM–10:00 AM

Abstract

Introduction: Fecal microbiota spores, live-brpk (VOWST™; formerly SER-109; now VOS for Vowst Oral Spores), an oral microbiota-based therapeutic comprised of Firmicutes spores, was well tolerated/significantly reduced risk of Clostridioides difficile infection (CDI) recurrence vs placebo through 8 weeks in ECOSPOR III (NCT03183128).

Research Question or Hypothesis: What impact did VOS have on health-related quality of life (HRQoL) of patients with recurrent CDI in ECOSPOR III?

Study Design: Secondary analysis of a randomized, controlled trial.

Methods: HRQoL of patients receiving VOS or matched placebo was evaluated using the Clostridioides difficile Quality of Life Survey (Cdiff32). Patients completed the Cdiff32 at baseline, Week 1, and Week 8 visits (or at recurrence/early termination visit). At Weeks 1 and 8, Mantel-Haenszel ?² test was used to determine differences in treatment groups in ranked ordinal outcomes and ANCOVA was used to determine differences in groups from baseline.

Results: This exploratory analysis included 182 (VOS, n=89; placebo, n=93) patients from the primary analysis of ECOSPOR III. Baseline total and individual domain Cdiff32 scores were similarly low between groups. At Week 1, proportions of patients with improvement in Cdiff32 total score was higher in the VOS vs placebo (49.4% vs 26.9%; P=0.012) groups; this proportion was also significantly higher at Week 8 (66.3% vs 48.4%; P=0.001). Greater improvements were seen in total, physical domain, and subdomain scores in the VOS group (vs placebo) at Week 1; continued improvements were seen at Week 8. Cdiff32 scores were significantly higher in patients without vs with on-study CDI recurrence (least-squares mean treatment difference [95% CI] for total: -17.1 [-23.1 to -11.2]; P<0.001). Patients receiving VOS had improvements in total and individual domain Cdiff32 scores, regardless of on-study CDI recurrence through Week 8.

Conclusion: Through 8 weeks, VOS was associated with rapid improvement in quality of life, regardless of clinical outcome.

Presenting Author

Sissi V. Pham PharmD
AESARA, Inc

Authors

Kevin W. Garey PharmD, MS
Anne J. Gonzales-Luna PharmD
PLACEHOLDER

Lisa von Moltke MD
Seres Therapeutics