in the ECOSPOR IV study2
†Clostridioides difficile (C. diff) infection.
ABX, antibiotics.
REFERENCES: 1. VOWST [Prescribing Information]. Cambridge, MA: Seres Therapeutics, Inc. and Nestlé Health Science. 06/2024. 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
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.
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Testing the category description for testing purposes
| ECOSPOR III |
|---|
|
Multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in adults (≥18 years) with recurrent C. diff 1-3 |
|
Primary Endpoint
Secondary Endpoints
|
Recurrence confirmed with C. diff toxin test and ≥3 unformed bowel movements per day over 2 days*
|
|
10–21 days of vancomycin (125 mg QID) or fidaxomicin (200 mg BID)
|
ECOSPOR III efficacy endpoints based on intent-to-treat population.
Data were rounded to the nearest whole number for presentation.
ECOSPOR IV was an open-label, single arm study of 263 participants with ≥1 C. diff recurrences evaluating the safety of VOWST; the secondary endpoint was efficacy5
Limitations: open-label study design yields descriptive results limiting interpretations of efficacy and safety without a comparator
| ECOSPOR IV |
|---|
|
Multicenter, open-label, single-arm trial in adults (≥18 years) with recurrent C. diff 5 |
|
Primary Endpoint
Secondary Endpoints
|
|
Recurrence confirmed with
C. diff
toxin test
or
PCR
and ≥3 unformed bowel movements per day over 2 days*
|
|
10–42 days of vancomycin
or 10–25 days of fidaxomicin |
Toxin and PCR testing were utilized to determine initial eligibility. Recurrences while on study were confirmed by toxin testing to ensure study integrity.
†25 placebo recipients and 4 VOWST recipients discontinued ECOSPOR III and enrolled in ECOSPOR IV after experiencing a C. Diff recurrence within 8 weeks.
Data were rounded to the nearest whole number for presentation.
