DYSBIOSIS CAN MAKE RECURRENT C. DIFF* GO EXTRA ROUNDS1,2
AS EARLY AS FIRST C. DIFF RECURRENCE,
KNOCK IT OUT WITH THE
1-2
GUT PUNCH
Prescribe VOWST® following an antibiotic to deliver
superior efficacy vs an antibiotic alone3-5
AS EARLY AS FIRST C. DIFF RECURRENCE,
KNOCK IT OUT WITH THE
1-2
GUT
PUNCH
Prescribe VOWST® following an antibiotic to deliver
superior efficacy vs an antibiotic alone3-5
*Clostridioides difficile (C. diff) infection.
VOWST is the FIRST and ONLY FDA-approved orally administered microbiome
therapeutic to prevent C. diff recurrence3,4
in the ECOSPOR IV study10
ABX, antibiotics; rCDI, recurrent C. diff infection.
REFERENCES: 1. Jain N, Umar TP, Fahner A-F, Gibietis V. Advancing therapeutics for recurrent clostridioides difficile infections: an overview of vowst’s FDA approval implications. Gut Microbes. 2023;15(1):2232137. doi:10.1080/19490976.2023.2232137 2. Feuerstadt P, Theriault N, Tillotson G. The burden of CDI in the United States: a multifactorial challenge. BMC Infect Dis. 2023;23(132):1-8. doi:10.1186/s12879-023-08096-0 3. VOWST [Prescribing Information]. Cambridge, MA: Seres Therapeutics, Inc. and Nestlé Health Science. 06/2024. 4. 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 5. 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 6. Vincent C, Miller MA, Edens TJ, et al. Bloom and bust: intestinal microbiota dynamics in response to hospital exposures and Clostridium difficile colonization or infection. Microbiome. 2016;4:12. doi:10.1186/s40168-016-0156-3 7. Chilton CH, Pickering DS, Freeman J. Microbiologic factors affecting Clostridium difficile recurrence. Clin Microbiol Infect. 2018;24(5):476-482. doi:10.1016/j.cmi.2017.11.017 8. McGovern BH, Ford CB, Henn MR, et al. SER-109, an investigational microbiome drug to reduce recurrence after Clostridioides difficile infection: lessons learned from a phase 2 trial. Clin Infect Dis. 2021;72(12):2132-2140. doi:10.1093/cid/ciaa387 9. Khanna S, Sims M, Louie TJ, et al. SER-109: An oral investigational microbiome therapeutic for participants with recurrent Clostridioides difficile infection (rCDI). Antibiotics (Basel). 2022;11(9):1234. doi:10.3390/antibiotics11091234 10. 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.
