Recurrent C. diff* (rCDI) can lead to clinical, social, and economic burden^1,2

CLINICAL BURDEN

Increased complications and hospitalizations¹

84^%
of patients (82/98)

with rCDI had a C. diff–related re-hospitalization within 12 months^3,†

SOCIAL BURDEN

Negative impact on quality of life^4,5

Patients with rCDI reported decreased QoL across measures relating to physical, emotional, professional, and financial consequences^4,5

^~90^%
of surveyed patients (210/235)

with rCDI were worried about having another recurrence⁵

ECONOMIC BURDEN

Substantial burden on healthcare utilization resources

^~$2.8
billion

Estimated annual economic cost
in the United States⁶

2x
higher

total hospitalization cost
for treating rCDI than for CDI⁶

In one real-world study, per-patient cost increased significantly with each CDI recurrence, with total all-cause direct medical costs rising from $156K at first recurrence to $245K^‡ at 3 or more recurrences^6,7

^† Data derived from a US study designed to identify the health consequences of recurrent CDI including need for repeat hospitalization, intensive care unit (ICU) stay, and surgery. The study population included 98 patients who developed recurrent CDI (defined as infection that occurred within 56 days after the end of treatment of the original infection).³

^‡ Based on a longitudinal retrospective analysis of real-world data for commercially insured adults from January 2010 to June 2017. All-cause direct medical costs included inpatient, outpatient (physician office visits, outpatient hospital visits, emergency department visits, other outpatient services), and prescription drug costs. Costs have been adjusted to reflect 2023 US dollar amounts.⁶

Antibiotics alone are not always enough
to stop the vicious cycle of rCDI

Many patients with rCDI have significant dysbiosis of the intestinal microbiome^1,8

C. diff–specific antibiotics

Beneficial bacteria C. diff spores

C. diff spores Toxin-producing C. diff bacteria

Toxin-producing C. diff bacteria

As a single-treatment approach, antibiotics alone have limited ability to prevent rCDI, as they do not treat and may worsen the underlying dysbiosis¹

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*Clostridioides difficile (C. diff) infection.

REFERENCES: 1. 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 2. U.S. Department of Health and Human Services. Antibiotic resistance threats in the United States: 2019. Accessed May 10, 2024. https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf 3. Rodrigues R, Barber GE, Ananthakrishnan AN. A comprehensive study of costs associated with recurrent Clostridium difficile infection. Infect Control Hosp Epidemiol. 2017;38(2):196-202. doi:10.1017/ice.2016.246 4. Armstrong EP, Malone DC, Franic DM, Pham SV, Gratie D, Amin A. Patient experiences with Clostridioides difficile infection and its treatment: a systematic literature review. Infect Dis Ther. 2023;12(7):1775-1795. doi:10.1007/s40121-023-00833-x 5. Lurienne L, Bandinelli P-A, Galvain T, Coursel C-A, Oneto C, Feuerstadt P. Perception of quality of life in people experiencing or having experienced a Clostridioides difficile infection: a US population survey. J Patient Rep Outcomes. 2020;4(1):14. doi:10.1186/s41687-020-0179-1 6. Feuerstadt P, Stong L, Dahdal DN, Sacks N, Lang K, Nelson WW. Healthcare resource utilization and direct medical costs associated with index and recurrent Clostridioides difficile infection: a real-world data analysis. J Med Econ. 2020;23(6):603-609. doi:10.1080/13696998.2020.1724117 7. U.S. Bureau of Labor Statistics. CPI Inflation Calculator. Accessed April 27, 2024. https://www.bls.gov/ 8. 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 9. 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 10. 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 11. 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 12. 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 13. 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 14. VOWST [Prescribing Information]. Cambridge, MA: Seres Therapeutics, Inc. and Nestlé Health Science. 06/2024. 15. 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

ECOSPOR III
Multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in adults (≥18 years) with recurrent C. diff ^1-3
Primary Endpoint Recurrence at 8 weeks* Secondary Endpoints Adverse events within 24 weeks Recurrence at 4, 12, 24 weeks*
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 IV
Multicenter, open-label, single-arm trial in adults (≥18 years) with recurrent C. diff ⁵
Primary Endpoint Adverse events within 24 weeks Secondary Endpoints Recurrence at 4, 8, 12, 24 weeks
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

Recurrent C. diff* (rCDI) can lead to clinical, social, and economic burden1,2