P0162 - Health-Related Quality of Life With Fecal Microbiota Spores, Live (Formerly SER-109), an Oral Microbiota Therapeutic for Recurrent Clostridioides Difficile Infection: Exploratory Analysis of ECOSPOR IV

Award: Presidential Poster Award

Anne J.. Gonzales-Luna, PharmD¹, David A.. Lombardi, PhD², Lisa von Moltke, MD², Dina Hot, PhD³, Caterina Oneto, MD^4
1University of Houston College of Pharmacy, Houston, TX; ²Seres Therapeutics, Cambridge, MA; ³Aimmune Therapeutics, a Nestlé Health Science Company, Brisbane, CA; ⁴Vanguard Gastroenterology, New York, NY

Introduction: Clostridioides difficile infection (CDI) is a burden on health-related quality of life (HRQoL), with negative effects generally increasing with the number of recurrent CDI (rCDI) episodes. In the Phase 3 ECOSPOR III trial, fecal microbiota spores, live (FMS; formerly SER-109), an FDA-approved oral microbiota-based therapeutic, significantly reduced rCDI rates at 8 weeks compared with placebo in patients (pts) with rCDI (12% vs 40%, respectively). FMS was also significantly associated with improved HRQoL, regardless of clinical outcome, as assessed by the disease-specific Cdiff32 questionnaire. We report results from an exploratory analysis of ECOSPOR IV evaluating the impact of FMS on HRQoL as assessed by a generic HRQoL instrument in a subset of the overall population (prespecified) and by number of recurrent episodes (post hoc).

Methods: ECOSPOR IV is an open-label, single-arm, Phase 3 study (NCT03183141) evaluating safety/tolerability and rCDI rate after FMS treatment. Pts in this analysis had ≥1 CDI recurrence (ie, history of ≥2 CDI episodes) and were further categorized as having first recurrence CDI (frCDI) or multiple recurrence CDI (mrCDI). Within 4 days after completing antibiotic treatment, pts received 4 FMS capsules orally, once daily for 3 consecutive days. HRQoL was assessed with the EuroQol 5 Dimensions 5 Level (EQ-5D-5L); the EQ-5D-5L visual analog scale (VAS), a self-rated measure of quality of health on a scale of 0 to 100 (100 indicating the best health imaginable), was completed at baseline and Week 8.

Results: A total of 106 pts (frCDI, n=29; mrCDI, n=77) completed the VAS at baseline, and 100 pts (frCDI, n=28; mrCDI, n=72) completed the VAS at Week 8. Overall, pts reported a baseline mean (SD) VAS score of 67.6 (19.7) points, indicating fair to good health status, which increased to 77.8 (19.0) at Week 8; average (SD) increase was 9.2 (18.07) points, indicating improvement in health status. When analyzed by frCDI or mrCDI, baseline mean (SD) VAS scores were 64.1 (20.3) and 68.9 (19.4), respectively; mean (SD) VAS scores improved at Week 8 to 74.4 (22.5) for frCDI and 79.2 (17.4) for mrCDI. Mean (SD) changes from baseline on VAS scores for FMS-treated pts with frCDI or mrCDI were 6.8 (20.9) or 10.0 (17.1), respectively.

Discussion: HRQoL appeared improved in FMS-treated pts in ECOSPOR IV, regardless of the number of prior rCDI episodes, supporting prior findings of HRQoL improvement in FMS-treated pts from ECOSPOR III.



Disclosures:


Anne J.. Gonzales-Luna, PharmD¹, David A.. Lombardi, PhD², Lisa von Moltke, MD², Dina Hot, PhD³, Caterina Oneto, MD⁴. P0162 - Health-Related Quality of Life With Fecal Microbiota Spores, Live (Formerly SER-109), an Oral Microbiota Therapeutic for Recurrent Clostridioides Difficile Infection: Exploratory Analysis of ECOSPOR IV, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.