Explore the efficacy of VOWST® used sequentially after antibiotics
VOWST used following antibiotics was studied in a rigorous phase 3 clinical development program1,2
The 1-2 punch of an antibiotic followed by VOWST delivered superior, durable efficacy through 24 weeks3,4
ECOSPOR III: Statistically significant reduction of C. diff* recurrence at both
8 and 24 weeks vs antibiotics alone1,3
A Number Needed to Treat (NNT) of 4 to avoid 1 C. diff recurrence.1
1-2 PUNCH:
A dual approach with antibiotics then VOWST may increase your patient’s odds of beating another recurrence1,3,4
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, and 24 weeks. In the intent-to-treat population, participants received standard-of-care antibiotics (vancomycin or fidaxomicin) and laxative followed by VOWST or placebo. Those lost to follow-up, terminated prematurely, or who died prior to end of study time interval counted as a recurrence. Data were rounded to the nearest whole number for presentation.1,3,4
* Clostridioides difficile (C. diff) infection.
†Calculated by the rate of recurrence, which was significantly lower in VOWST recipients compared with those receiving antibiotics alone—12% vs 40%, respectively—a 0.32 relative risk (95% confidence interval, 0.18, 0.58; P<0.001).1,3
‡ Relative risk of 0.46 (95% CI, 0.30, 0.73; P<0.001).3,4
Multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in adults (≥18 years) with recurrent C. diff1
PRIMARY ENDPOINT2
Recurrence at 8 weeks‡
SECONDARY ENDPOINT2
Adverse events within 24 weeks and recurrence at 4, 12, and 24 weeks‡
Recurrence confirmed with C. diff toxin test and ≥3 unformed bowel movements per day for 2+ consecutive days.1
ECOSPOR III efficacy endpoints based on intent-to-treat population.
182
adults with ≥2 C. diff recurrences1,3
89
received VOWST following antibiotics1,3
93
received placebo following antibiotics1,3
Participants received 10–21 days of vancomycin (125 mg QID) or fidaxomicin (200 mg BID).1,2
Data were rounded to the nearest whole number for presentation.
VOWST was used as early as first C. diff* recurrence in ECOSPOR IV
ECOSPOR IV: Secondary endpoint, clinical response at 8 weeks
This open-label, single-arm study design primary outcome evaluated the safety and tolerability of VOWST up to 24 weeks.2
Limitations: Open-label, single-arm study design yields descriptive results limiting interpretations of efficacy and safety without a comparator.
ECOSPOR IV evaluated the safety of VOWST (adverse events within 24 weeks); secondary endpoints evaluated C. diff recurrence at 4, 8, 12, and 24 weeks. Participants received VOWST after standard-of-care antibiotic treatment (vancomycin or fidaxomicin) and laxative. Data were rounded to the nearest whole number for presentation.2
At 24 weeks, 86% of participants remained recurrence free2
* Clostridioides difficile (C. diff) infection.
Multicenter, open-label, single-arm trial in adults (≥18 years) with recurrent C. diff2
Limitations: Open-label, single-arm study design yields descriptive results limiting interpretations of efficacy and safety without a comparator.
PRIMARY ENDPOINT2
Adverse events within 24 weeks
SECONDARY ENDPOINT2
Recurrence at 4, 8, 12, and 24 weeks
Recurrence confirmed with C. diff toxin test or PCR and ≥3 unformed bowel movements per day for 2+ consecutive days.2,§
Toxin or PCR testing was utilized to determine initial eligibility. Recurrences while on study were confirmed by toxin testing to ensure study integrity.1,2
234
new adults with ≥1 C. diff recurrence2
29
non-responders from ECOSPOR III2,II
263
received VOWST following antibiotics; nearly 1/3 had a first C. diff recurrence at study entry2
Participants received 10–42 days of vancomycin or 10–25 days of fidaxomicin.2
25 placebo recipients and 4 VOWST recipients discontinued ECOSPOR III and enrolled in ECOSPOR IV.3
ABX, antibiotics.
REFERENCES: 1. Feuerstadt P, Louie TJ, Lashner B, et al. SER-109, an oral microbiome therapy for recurrent Clostridioides difficile infection. N Engl J Med. 2022;386:220-229. doi:10.1056/NEJMoa2106516 2. Sims MD, Khanna S, Feuerstadt P, et al. Safety and tolerability of SER-109 as an investigational microbiome therapeutic in adults with recurrent Clostridioides difficile infection: a phase 3, open-label, single-arm trial. JAMA Netw Open. 2023;6(2):e2255758. doi:10.1001/jamanetworkopen.2022.55758 3. VOWST [Prescribing Information]. Cambridge, MA: Seres Therapeutics, Inc. and Nestlé Health Science. 06/2024. 4. Cohen SH, Louie TJ, Sims M, et al. Extended follow-up of microbiome therapeutic SER-109 through 24 weeks for recurrent Clostridioides difficile infection in a randomized clinical trial. JAMA. 2022;328(20):2062-2064. doi:10.1001/jama.2022.16476 5. Data on File. Nestlé Health Science.
INDICATION
VOWST is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI).
Limitation of Use: VOWST is not indicated for treatment of CDI.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Transmissible infectious agents: Because VOWST is manufactured from human fecal matter, it may carry a risk of transmitting infectious agents. Report any infection that is suspected to have been transmitted by VOWST to Aimmune Therapeutics, Inc. at 1-833-246-2566.
Potential presence of food allergens: VOWST may contain food allergens. The potential to cause adverse reactions due to food allergens is unknown.
ADVERSE REACTIONS
The most common adverse reactions (reported in ≥5% of Vowst-treated participants, and at a rate greater than placebo) were abdominal distension (31.1%), fatigue (22.2%), constipation (14.4%), chills (11.1%), and diarrhea (10.0%).
To report SUSPECTED ADVERSE REACTIONS, contact Aimmune Therapeutics at 1-833-AIM-2KNO (1-833-246-2566), or the FDA at 1-800-FDA-1088, or visit www.fda.gov/MedWatch.
DRUG INTERACTIONS
Do not administer antibacterials concurrently with VOWST.
Please see full Prescribing Information and Patient Information.
