SER-109 & Clostridioides difficile infection (CDI) (recurrent)

Approval status

The US Food and Drug Administration (FDA) approved SER‑109 on April 26, 2023 as the first orally administered fecal microbiota–based product for preventing Clostridioides difficile infection (CDI) (recurrent) in adults aged ≥18 years after completing antibiotic treatment for CDI. The indication is specifically for prevention of CDI recurrence, based on the phase 3 ECOSPOR III trial showing significantly lower recurrence rates with SER‑109 versus placebo (1, 2, 3, 4, 5).

Randomized clinical trials (RCTs)

NCT02437487
demonstrated that early engraftment of SER-109 was linked to a decrease in the recurrence of CDI. Additionally, the trial observed a favorable safety profile (7).

NCT03183128
demonstrated

• that for patients who experienced symptom resolution of C. difficile infection following treatment with standard-of-care antibiotics, the oral administration of SER-109 was more effective than a placebo in reducing the risk of recurrent infection. Additionally, the safety profile observed for SER-109 was comparable to that of the placebo (4)


• that in a secondary analysis SER-109 was associated with rapid and steady improvement in HRQOL compared with placebo through 8 weeks, an important patient-reported outcome (6).

SER-109 demonstrated greater effectiveness than a placebo in decreasing the recurrence of Clostridioides difficile infection (CDI) by Week 8. The recurrence rate was 12% for those treated with SER-109 compared to 40% for those given a placebo, with the difference being statistically significant (p < 0.001). This was observed in adults who had a history of recurrent CDI, and the treatment also showed a favorable safety profile (5).

References

(1) Stallhofer et al. 2024 Visc Med 40(2): 82-91
(2) fda-approves-first-orally-administered-fecal-microbiota-product-prevention-recurrence-clostridioides
(3) Benech et al. 2024 Clinical Microbiology and Infection 30: 462-468
(4) Feuerstadt et al. 2022 N Engl J Med 386: 220-229
(5) Khanna et al. 2022 Antibiotics (Basel) 11(9): 1234
(6) Garey et al. 2023 JAMA Netw Open 6: e2253570
(7) McGovern et al. 2021 cid 2021: 72

see also:
Clostridioides (Clostridium) difficile & Firmicutes / Bacillota
Clostridioides difficile infection (CDI) (recurrent) & Drugs/Treatments
Fecal Microbiota Transplantation (FMT) & Clostridioides difficile infection (CDI) (recurrent)
Microbiome-based therapeutics & Clostridioides difficile infection (CDI) (recurrent)
Natural live bacterial therapeutics & Clostridioides difficile infection (CDI) (recurrent)
Probiotics (living agents) & Clostridioides difficile infection (recurrent)