VOWST WAS STUDIED IN A RIGOROUS PHASE 3 CLINICAL DEVELOPMENT PROGRAM
VOWST PROVIDED SUPERIOR PREVENTION OF
C. DIFF
RECURRENCE VS. ANTIBIOTICS ALONE
Statistically significant reduction of C. diff recurrence at 8 weeks1,2*
- A Number Needed to Treat (NNT) of 4 to avoid 1 C. diff recurrence2
VOWST PROVIDED A DURABLE RESPONSE
AT 24 WEEKS1,3
Statistically significant reduction of
C. diff
recurrence compared to
antibiotics alone1,3†
* Calculated by the rate of C. diff recurrence, which was significantly lower in VOWST recipients compared to those receiving antibiotics alone—12% vs. 40%, respectively—a 0.32 relative risk (95% confidence interval, 0.18, 0.58; P <0.001).1,2
† Relative risk of 0.46 (95% CI, 0.30, 0.73).
ECOSPOR III was a Phase 3, multicenter, double-blind, randomized, placebo-controlled trial evaluating C. diff recurrence at 8 weeks; secondary endpoints at 4, 12, 24 weeks. In the intent-to-treat population, participants received standard-of-care antibiotics (vancomycin/fidaxomicin) and laxative followed by VOWST or placebo. Those lost to follow-up, terminated prematurely, or died prior to end of study time interval counted as a recurrence. Data were rounded to the nearest whole number for presentation.
ECOSPOR IV SECONDARY ENDPOINT
CLINICAL RESPONSE AT 8 WEEKS
AT 8 WEEKS
PERCENTAGE OF PARTICIPANTS WITHOUT C. DIFF RECURRENCE5
ECOSPOR IV was an open-label, single-arm study. The primary outcome evaluated the safety and tolerability of VOWST up to 24 weeks
Limitations: Open-label, single-arm study design yields descriptive results limiting interpretations of efficacy and safety without a comparator
- Nearly 1/3 had a first C. diff recurrence at baseline
AT 24 WEEKS
86% OF RECIPIENTS
REMAINED RECURRENCE FREE5
ECOSPOR IV evaluated the safety of VOWST (adverse events within 24 weeks); secondary endpoints evaluated C. diff recurrence at 4, 8, 12, 24 weeks. Participants received VOWST after standard-of-care antibiotics treatment (vancomycin/fidaxomicin) and laxative. Data were rounded to the nearest whole number for presentation.
REFERENCES: 1. VOWST [Prescribing Information]. Cambridge, MA: Seres Therapeutics, Inc. and Nestlé Health Science. 04/2023. 2. Feuerstadt P, Louie TJ, Lashner B, et al. N Engl J Med. 2022;236:220-229. doi: 10.1056/NEJMoa2106516. 3. Cohen SH, Louie TJ, Sims M, et al. JAMA. Published Online: October 19, 2022. doi: 10.1001/jama.2022.16476. 4. Data on file. 5. Sims MD, Khanna S, Feuerstadt P, et al. JAMA Network Open. 2023;6(2):e2255758. doi: 10.1001/jamanetworkopen.2022.55758.
