SER-109 (VOWST™): A Review in the Prevention of Recurrent Clostridioides difficile Infection

Fenton C, Kang CN. Consider new therapies for the treatment and prevention of Clostridioides difficile infection. Drugs Ther Perspect. 2023;39:237–42.

Article  Google Scholar 

Gawey BJ, Khanna S. Clostridioides difficile infection: landscape and microbiome therapeutics. Gastroenterol Hepatol. 2023;19(6):319–28.

Google Scholar 

Gonzales-Luna AJ, Carlson TJ, Garey KW. Emerging options for the prevention and management of Clostridioides difficile infection. Drugs. 2023;83(2):105–16.

Article  PubMed  PubMed Central  Google Scholar 

Nagarakanti S, Orenstein R. Treating Clostridioides difficile: could microbiota-based live biotherapeutic products provide the answer? Infect Drug Resist. 2023;16:3137–43.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Buckley AM, Moura IB, Wilcox MH. The potential of microbiome replacement therapies for Clostridium difficile infection. Curr Opin Gastroenterol. 2022;38(1):1–6.

Article  CAS  PubMed  Google Scholar 

Fitzpatrick F, Skally M, Brady M, et al. European practice for CDI treatment. Adv Exp Med Biol. 2018;1050:117–35.

Article  PubMed  Google Scholar 

Johnson S, Lavergne V, Skinner AM, et al. Clinical practice guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 focused update guidelines on management of Clostridioides difficile infection in adults. Clin Infect Dis. 2021;73(5):e1029–44.

Article  CAS  PubMed  Google Scholar 

Kelly CR, Fischer M, Allegretti JR, et al. ACG clinical guidelines: prevention, diagnosis, and treatment of Clostridioides difficile infections. Am J Gastroenterol. 2021;116(6):1124–47.

Article  CAS  PubMed  Google Scholar 

Khanna S, Sims M, Louie TJ, et al. SER-109: an oral investigational microbiome therapeutic for patients with recurrent Clostridioides difficile infection (rCDI). Antibiotics (Basel). 2022;11(9):1–11.

Google Scholar 

Blair HA. RBX2660 (REBYOTA®) in preventing recurrence of Clostridioides difficile infection: a profile of its use in the USA. Drugs Ther Perspect. 2023;39:331–8.

Article  Google Scholar 

Seres Therapeutics Inc. VOWST (fecal microbiota spores, live-brpk) capsules, for oral administration: US prescribing information. 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=99e5a37a-930c-4641-bcdd-7013ec1c15fe. Accessed 31 Jan 2024.

McChalicher CWJ, Lombardo MJ, Khanna S, et al. Manufacturing processes of a purified microbiome therapeutic reduce risk of transmission of potential bacterial pathogens in donor stool. J Infect Dis. 2023;228(10):1452–5.

Article  PubMed  PubMed Central  Google Scholar 

McChalicher C, Abdulaziz A, Zhou SS, et al. Manufacturing process of SER-109, a purified investigational microbiome therapeutic, reduces risk of coronavirus transmission from donor stool. Open Forum Infect Dis. 2022;9(9):1–3.

Article  Google Scholar 

Bryant JA, Diao LY, O’Brien EJ, et al. Rapid conversion of primary to secondary bile acids in subjects with recurrent Clostridioides difficile infection (CDI) following SER-109, an investigational microbiome therapeutic [abstract no. 809]. Gastroenterology. 2021;160(6):S-168.

Article  Google Scholar 

Bryant JA, Vulic M, Desjardins C, et al. Impact of SER-109, an investigational microbiome therapeutic, on stool fatty acid metabolites in a phase 3 randomized trial (ECOSPOR III) for treatment of recurrent Clostridioides difficile infection (CDI) [abstract no. 110]. Gastroenterology. 2022;162(7):S-21.

Article  Google Scholar 

Desjardins C, Bryant JA, Walsh E, et al. Engraftment of investigational microbiome therapeutic SER-109 is durable through 24 weeks in a randomized trial (ECOSPOR III) for the treatment of recurrent Clostridioides difficile infection [abstract no. Su1606]. Gastroenterology. 2022;162(7):S-650.

Article  Google Scholar 

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(3):220–9.

Article  CAS  PubMed  Google Scholar 

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):2132–40.

Article  CAS  PubMed  Google Scholar 

Hasson B, Kraft C, Pardi D, et al. Comparability of gastrointestinal microbiome profiles in patients with first or multiply recurrent Clostridioides difficile infection: implications for treatment [abstract]. In: American Society for Microbiology (ASM) Microbe. 2023.

Khanna S, Pardi DS, Kelly CR, et al. A novel microbiome therapeutic increases gut microbial diversity and prevents recurrent Clostridium difficile infection. J Infect Dis. 2016;214(2):173–81.

Article  PubMed  Google Scholar 

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):1–13.

Article  Google Scholar 

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):2062–4.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Berenson CS, Lashner B, Korman L, et al. Prevalence of comorbid factors in patients with recurrent Clostridioides difficile infection in ECOSPOR III, a randomized trial of an oral microbiota-based therapeutic. Clin Infect Dis. 2023;77(11):1504–10.

Article  PubMed  PubMed Central  Google Scholar 

Kraft CS, Lombardo MJ, Louie T, et al. Characterization of ribotypes among study participants in a phase 3 trial of investigational microbiome therapeutic SER-109 to reduce recurrent Clostridioides difficile infection [abstract plus poster 5766]. In: World Microbe Forum. 2021.

Garey KW, Jo J, Gonzales-Luna AJ, et al. Assessment of quality of life among patients with recurrent Clostridioides difficile infection treated with investigational oral microbiome therapeutic SER-109: secondary analysis of a randomized clinical trial. JAMA Netw Open. 2023;6(1): e2253570.

Article  PubMed  PubMed Central  Google Scholar 

Huang ES, Lashner B, Sims M, et al. Durability of the clinical response to SER-109, an investigational oral microbiome therapeutic, in a phase 3 open-label trial (ECOSPOR IV) in patients with recurrent Clostridioides difficile infection [abstract no. 694]. Gastroenterology. 2023;164(6 Suppl):S-140.

Google Scholar 

Lashner B, von Moltke L, De A, et al. Safety and efficacy of fecal microbiota spores, live-brpk (formerly SER-109) in older patients with recurrent Clostridioides difficile infection: findings from an integrated analysis of phase 3 trials [abstract no. S77]. Am J Gastroenterol. 2023;118(12S):S21.

Article  Google Scholar 

US FDA. Clinical review memo: VOWST. 2022. https://www.fda.gov/media/168274/download. Accessed 31 Jan 2024.

Deeks ED. Bezlotoxumab: a review in preventing Clostridium difficile infection recurrence. Drugs. 2017;77(15):1657–63.

Article  CAS  PubMed  Google Scholar 

Chopra T. A profile of the live biotherapeutic product RBX2660 and its role in preventing recurrent Clostridioides difficile infection. Expert Rev Anti Infect Ther. 2023;21(3):243–53.

Article  CAS  PubMed  Google Scholar 

Orenstein R. The role of microbiome-based therapeutics in Clostridioides difficile infection: durable, long-term results of RBX2660. Infect Dis Ther. 2023;12(1):1–7.

Article  PubMed  Google Scholar 

Cohen S, Louie T, Berenson C, et al. Healthcare resource utilization in a phase 3 trial of SER-109 in patients with recurrent Clostridioides difficile infection [abstract]. Antimicrob Steward Healthc Epidemiol. 2022;2(Suppl 1): s73.

Article  PubMed Central  Google Scholar 

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