Advancing therapeutics for recurrent clostridioides difficile infections: an overview of vowst’s FDA approval and implications

References

• Balsells E, Shi T, Leese C, Lyell I, Burrows J, Wiuff C, Campbell H, Kyaw MH, Nair H. Global burden of Clostridium difficile infections: a systematic review and meta-analysis. J Glob Health. 2019 Jun;9(1):010407. doi:10.7189/jogh.09.010407. PMID: 30603078; PMCID: PMC6304170.
   PubMed Web of Science ®Google Scholar
• Dilnessa T, Getaneh A, Hailu W, Moges F, Gelaw B, Chang Y-F. Prevalence and antimicrobial resistance pattern of Clostridium difficile among hospitalized diarrheal patients: a systematic review and meta-analysis. PLoS One. 2022 Jan 13;17(1):e0262597. doi:10.1371/journal.pone.0262597. PMID: 35025959; PMCID: PMC8758073.
   PubMed Web of Science ®Google Scholar
• Vaishnavi C. Clinical spectrum & pathogenesis of Clostridium difficile associated diseases. Indian J Med Res. 2010 Apr;131:487–10. PMID: 20424299.
   PubMed Web of Science ®Google Scholar
• Sarker MR, Paredes-Sabja D. Molecular basis of early stages of Clostridium difficile infection: germination and colonization. Future Microbiol. 2012 Aug;7(8):933–943. doi:10.2217/fmb.12.64. PMID: 22913353.
   PubMed Web of Science ®Google Scholar
• Britton RA, Young VB. Role of the intestinal microbiota in resistance to colonization by Clostridium difficile. Gastroenterology. 2014 May;146(6):1547–1553. doi:10.1053/j.gastro.2014.01.059. Epub 2014 Feb 4. PMID: 24503131; PMCID: PMC3995857.
   PubMed Web of Science ®Google Scholar
• Spigaglia P. Recent advances in the understanding of antibiotic resistance in Clostridium difficile infection. Ther Adv Infect Dis. 2016 Feb;3(1):23–42. doi:10.1177/2049936115622891. PMID: 26862400; PMCID: PMC4735502.
   PubMed Web of Science ®Google Scholar
• Johnson S, Lavergne V, Skinner AM, Gonzales-Luna AJ, Garey KW, Kelly CP, Wilcox MH. 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 Sep 7;73(5):755–757. doi:10.1093/cid/ciab718. PMID: 34492699.
   PubMedGoogle Scholar
• Bainum TB, Reveles KR, Hall RG 2nd, Cornell K, Alvarez CA. Controversies in the prevention and treatment of clostridioides difficile infection in adults: a narrative review. Microorganisms. 2023 Feb 3;11(2):387. doi:10.3390/microorganisms11020387. PMID: 36838352; PMCID: PMC9963748.
   PubMed Web of Science ®Google Scholar
• Shah DN, Chan FS, Kachru N, Garcia KP, Balcer HE, Dyer AP, Emanuel JE, Jordan MD, Lusardi KT, Naymick G, et al. A multi-center study of fidaxomicin use for Clostridium difficile infection. Springerplus. 2016 Aug 2;5(1):1224. doi:10.1186/s40064-016-2825-x. PMID: 27536508; PMCID: PMC4970984.
   PubMedGoogle Scholar
• World Health Organization. Lack of innovation set to undermine antibiotic performance and health gains. WHO. June 2022 [online]. [accessed 2023 June 24]. https://www.who.int/news/item/22-06-2022-22-06-2022-lack-of-innovation-set-to-undermine-antibiotic-performance-and-health-gains.
   Google Scholar
• Gupta S, Allen-Vercoe E, Petrof EO. Fecal microbiota transplantation: in perspective. Therap Adv Gastroenterol. 2016 Mar;9(2):229–239. doi:10.1177/1756283X15607414. PMID: 26929784; PMCID: PMC4749851.
   PubMed Web of Science ®Google Scholar
• Hvas CL, Dahl Jørgensen SM, Jørgensen SP, Storgaard M, Lemming L, Hansen MM, Erikstrup C, Dahlerup JF. Fecal microbiota transplantation is superior to fidaxomicin for treatment of recurrent clostridium difficile infection. Gastroenterology. 2019 Apr;156(5):1324–1332.e3. doi:10.1053/j.gastro.2018.12.019. Epub 2019 Jan 2. PMID: 30610862.
   PubMed Web of Science ®Google Scholar
• Hyun J, Lee SK, Cheon JH, Yong DE, Koh H, Kang YK, Kim MH, Sohn Y, Cho Y, Baek YJ. et al. Faecal microbiota transplantation reduces amounts of antibiotic resistance genes in patients with multidrug-resistant organisms. Antimicrob Resist Infect Control. 2022 Jan 29;11(1):20. doi:10.1186/s13756-022-01064-4. PMID: 35093183; PMCID: PMC8800327.
   PubMed Web of Science ®Google Scholar
• Kao D, Roach B, Silva M, Beck P, Rioux K, Kaplan GG, Chang HJ, Coward S, Goodman KJ, Xu H, et al. Effect of oral capsule– vs colonoscopy-delivered fecal microbiota transplantation on recurrent clostridium difficile infection. JAMA. 2017 Nov 28;318(20):1985–1993. doi:10.1001/jama.2017.17077. PMID: 29183074; PMCID: PMC5820695.
   PubMed Web of Science ®Google Scholar
• Patel NC, Griesbach CL, DiBaise JK, Orenstein R. Fecal microbiota transplant for recurrent Clostridium difficile infection: mayo clinic in Arizona experience. Mayo Clin Proc. 2013 Aug;88(8):799–805. doi:10.1016/j.mayocp.2013.04.022. PMID: 23910407.
   PubMed Web of Science ®Google Scholar
• van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, van Nood E, de Vos WM, Kuijper EJ, et al. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407–415. doi:10.1056/NEJMoa1205037. Epub 2013 Jan 16. PMID: 23323867.
   PubMed Web of Science ®Google Scholar
• Baunwall SMD, Terveer EM, Dahlerup JF, Erikstrup C, Arkkila P, Vehreschild MJ, Ianiro G, Gasbarrini A, Sokol H, Kump PK, et al. The use of Faecal Microbiota Transplantation (FMT) in Europe: a Europe-wide survey. Lancet Reg Health Eur. 2021 Jul 19;9:100181. doi:10.1016/j.lanepe.2021.100181. PMID: 34693388; PMCID: PMC8513118.
   PubMedGoogle Scholar
• Postigo R, Kim JH. Colonoscopic versus nasogastric fecal transplantation for the treatment of Clostridium difficile infection: a review and pooled analysis. Infection. 2012 Dec;40(6):643–648. doi:10.1007/s15010-012-0307-9. Epub 2012 Jul 31. PMID: 22847629.
   PubMed Web of Science ®Google Scholar
• Kelly CR, de Leon L, Jasutkar N. Fecal microbiota transplantation for relapsing Clostridium difficile infection in 26 patients: methodology and results. J Clin Gastroenterol. 2012 Feb;46(2):145–149. doi:10.1097/MCG.0b013e318234570b. PMID: 22157239.
   PubMed Web of Science ®Google Scholar
• Varga A, Kocsis B, Sipos D, Kása P, Vigvári S, Pál S, Dembrovszky F, Farkas K, Péterfi Z. How to apply FMT more effectively, conveniently and flexible - a comparison of FMT methods. Front Cell Infect Microbiol. 2021 Jun 4;11:657320. doi:10.3389/fcimb.2021.657320. PMID: 34150673; PMCID: PMC8213398.
   PubMed Web of Science ®Google Scholar
• Nagarakanti S, Orenstein R. Treating Clostridioides difficile: could microbiota-based live biotherapeutic products provide the answer? Infect Drug Resist. 2023 May 20;16:3137–3143. doi:10.2147/IDR.S400570. PMID: 37235073; PMCID: PMC10208241.
   PubMed Web of Science ®Google Scholar
• U.S. Food and Drug Administration. FDA approves first orally administered fecal microbiota product for the prevention of recurrence of clostridioides difficile infection [Internet]. 2023 [accessed 2023 May 15]. https://www.fda.gov/news-events/press-announcements/fda-approves-first-orally-administered-fecal-microbiota-product-prevention-recurrence-clostridioides.
   Google Scholar
• U.S. Food and Drug Administration. VOWST (fecal microbiota spores, live-brpk) capsules, for oral administration [Internet]. 2023 [accessed 2023 May 14].: https://www.fda.gov/media/167579/download.
   Google Scholar
• Łukawska A, Mulak A. Impact of primary and secondary bile acids on clostridioides difficile infection. Pol J Microbiol. 2022 Mar 14;71(1):11–18. doi:10.33073/pjm-2022-007. PMID: 35635171; PMCID: PMC9152914.
   PubMed Web of Science ®Google Scholar
• Theriot CM, Bowman AA, Young VB. Antibiotic-induced alterations of the gut microbiota alter secondary bile acid production and allow for clostridium difficile spore germination and outgrowth in the large intestine. mSphere. 2016 Jan 6;1(1):e00045–15. doi: 10.1128/mSphere.00045-15. PMID: 27239562; PMCID: PMC4863611.
   PubMed Web of Science ®Google Scholar
• Feuerstadt P, Louie TJ, Lashner B, Wang EEL, Diao L, Bryant JA, Sims M, Kraft CS, Cohen SH, Berenson CS, et al. SER-109, an oral microbiome therapy for recurrent clostridioides difficile infection. N Engl J Med. 2022 Jan 20;386(3):220–229. doi:10.1056/NEJMoa2106516. PMID: 35045228.
   PubMed Web of Science ®Google Scholar
• McGovern BH, Ford CB, Henn MR, Pardi DS, Khanna S, Hohmann EL, O’Brien EJ, Desjardins CA, Bernardo P, Wortman JR, 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 Jun 15;72(12):2132–2140. doi:10.1093/cid/ciaa387. PMID: 32255488; PMCID: PMC8204772.
   PubMed Web of Science ®Google Scholar
• Sims MD, Khanna S, Feuerstadt P, Louie TJ, Kelly CR, Huang ES, Hohmann EL, Wang EEL, Oneto C, Cohen SH, 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 Feb 1;6(2):e2255758. doi:10.1001/jamanetworkopen.2022.55758. PMID: 36780159; PMCID: PMC9926325.
   PubMed Web of Science ®Google Scholar
• Seres Therapeutics. Seres Therapeutics announces interim results from SER-109 phase 2 ECOSPOR study in multiply recurrent Clostridium difficile infection [Internet]. 2016 [accessed 2023 May 14]. https://ir.serestherapeutics.com/news-releases/news-release-details/seres-therapeutics-announces-interim-results-ser-109-phase-2.
   Google Scholar
• Khanna S, Pardi DS, Kelly CR, Kraft CS, Dhere T, Henn MR, Lombardo MJ, Vulic M, Ohsumi T, Winkler J, et al. A novel microbiome therapeutic increases gut microbial diversity and prevents recurrent clostridium difficile infection. J Infect Dis. 2016 Jul 15;214(2):173–181. doi:10.1093/infdis/jiv766. Epub 2016 Feb 8. PMID: 26908752.
   PubMed Web of Science ®Google Scholar
• Seres Therapeutics. ECOSPOR IV: an open-label study evaluating SER-109 in recurrent clostridioides difficile infection [Internet]. 2023 [accessed 2023 May 14]. https://clinicaltrials.gov/ct2/show/NCT03183141?term=ecospor+IV&draw=1&rank=1.
   Google Scholar
• Du C, Luo Y, Walsh S, Grinspan A. Oral fecal microbiota transplant capsules are safe and effective for recurrent clostridioides difficile infection: a systematic review and meta-analysis. J Clin Gastroenterol. 2021 Apr 1;55(4):300–308. doi:10.1097/MCG.0000000000001495. PMID: 33471490.
   PubMed Web of Science ®Google Scholar
• Marcella C, Cui B, Kelly CR, Ianiro G, Cammarota G, Zhang F. Systematic review: the global incidence of faecal microbiota transplantation-related adverse events from 2000 to 2020. Aliment Pharmacol Ther. 2021 Jan;53(1):33–42. doi:10.1111/apt.16148. Epub 2020 Nov 7. PMID: 33159374.
   PubMed Web of Science ®Google Scholar
• Halaweish HF, Boatman S, Staley C. Encapsulated fecal microbiota transplantation: development, efficacy, and clinical application. Front Cell Infect Microbiol. 2022 Mar 17;12:826114. doi:10.3389/fcimb.2022.826114. PMID: 35372103; PMCID: PMC8968856.
   PubMed Web of Science ®Google Scholar
• Satokari R, Mattila E, Kainulainen V, Arkkila PE. Simple faecal preparation and efficacy of frozen inoculum in faecal microbiota transplantation for recurrent Clostridium difficile infection–an observational cohort study. Aliment Pharmacol Ther. 2015 Jan;41(1):46–53. doi:10.1111/apt.13009. Epub 2014 Oct 29. PMID: 25355279.
   PubMed Web of Science ®Google Scholar
• Cammarota G, Ianiro G, Kelly CR, Mullish BH, Allegretti JR, Kassam Z, Putignani L, Fischer M, Keller JJ, Costello SP, et al. International consensus conference on stool banking for faecal microbiota transplantation in clinical practice. Gut. 2019 Dec;68(12):2111–2121. doi:10.1136/gutjnl-2019-319548. Epub 2019 Sep 28. PMID: 31563878; PMCID: PMC6872442.
   PubMed Web of Science ®Google Scholar
• Wynn AB, Beyer G, Richards M, Procedure EL. Screening, and cost of fecal microbiota transplantation. Cureus. 2023 Feb 17;15(2):e35116. doi:10.7759/cureus.35116. PMID: 36938236; PMCID: PMC10023044.
   PubMed Web of Science ®Google Scholar
• Konijeti GG, Sauk J, Shrime MG, Gupta M, Ananthakrishnan AN. Cost-effectiveness of competing strategies for management of recurrent Clostridium difficile infection: a decision analysis. Clin Infect Dis. 2014 Jun;58(11):1507–1514. doi:10.1093/cid/ciu128. Epub 2014 Mar 31. PMID: 24692533; PMCID: PMC4017891.
   PubMed Web of Science ®Google Scholar
• Lapointe-Shaw L, Tran KL, Coyte PC, Hancock-Howard RL, Powis J, Poutanen SM, Hota S, Deshpande A. Cost-effectiveness analysis of six strategies to treat recurrent clostridium difficile infection. PLoS One. 2016 Feb 22;11(2):e0149521. doi:10.1371/journal.pone.0149521. PMID: 26901316; PMCID: PMC4769325.
   PubMed Web of Science ®Google Scholar
• Gupta A, Ananthakrishnan AN. Economic burden and cost-effectiveness of therapies for Clostridiodes difficile infection: a narrative review. Therap Adv Gastroenterol. 2021 May 30;14:17562848211018654. doi:10.1177/17562848211018654. PMID: 34104214; PMCID: PMC8170348.
   Web of Science ®Google Scholar
• Rajasingham R, Enns EA, Khoruts A, Vaughn BP. Cost-effectiveness of treatment regimens for clostridioides difficile infection: an evaluation of the 2018 infectious diseases society of America guidelines. Clin Infect Dis. 2020 Feb 14;70(5):754–762. doi:10.1093/cid/ciz318. PMID: 31001619; PMCID: PMC7319265.
   PubMed Web of Science ®Google Scholar
• Cammarota G, Ianiro G, Tilg H, Rajilić-Stojanović M, Kump P, Satokari R, Sokol H, Arkkila P, Pintus C, Hart A, et al. European consensus conference on faecal microbiota transplantation in clinical practice. Gut. 2017 Apr;66(4):569–580. doi:10.1136/gutjnl-2016-313017. Epub 2017 Jan 13. PMID: 28087657; PMCID: PMC5529972.
   PubMed Web of Science ®Google Scholar
• Khanna S, Pardi DS, Jones C, Shannon WD, Gonzalez C, Blount K. RBX7455, a non-frozen, orally administered investigational live biotherapeutic, is safe, effective, and shifts patients’ microbiomes in a phase 1 study for recurrent clostridioides difficile infections. Clin Infect Dis. 2021 Oct 5;73(7):e1613–e1620. doi:10.1093/cid/ciaa1430. PMID: 32966574; PMCID: PMC8492147.
   PubMed Web of Science ®Google Scholar
• Finch research and development LLC. Efficacy, safety, and tolerability study of oral full-spectrum microbiotaTM (CP101) in subjects with recurrent C. Diff (PRISM3). 2022 [online]. [accessed 25 June 2023]. https://classic.clinicaltrials.gov/ct2/show/study/NCT03110133.
   Google Scholar
• OpenBiome. OpenBiome Announces New Direct Testing for SARS-CoV-2 in Fecal Microbiota Transplantation (FMT) preparations and release of new inventory. February 2021 [online]. [accessed 2023 June 25]. https://openbiome.org/feature/openbiome-announces-new-direct-testing-for-sars-cov-2-in-fecal-microbiota-transplantation-fmt-preparations-and-release-of-new-inventory/.
   Google Scholar
• Williams S Fecal microbiota transplantation is poised for a makeover. The Scientist. June 2021 [online]. [accessed 25th June 2023]. https://www.the-scientist.com/bio-business/fecal-microbiota-transplantation-is-poised-for-a-makeover-68805.
   Google Scholar
• Louie T, Golan Y, Khanna S, Bobilev D, Erpelding N, Fratazzi C, Carini M, Menon R, Ruisi M, Norman JM, et al. VE303, a defined bacterial consortium, for prevention of recurrent clostridioides difficile infection: a randomized clinical trial. JAMA. 2023 Apr 25;329(16):1356–1366. doi:10.1001/jama.2023.4314. PMID: 37060545; PMCID: PMC10105904.
   PubMed Web of Science ®Google Scholar
• Dsouza M, Menon R, Crossette E, Bhattarai SK, Schneider J, Kim YG, Reddy S, Caballero S, Felix C, Cornacchione L, et al. Colonization of the live biotherapeutic product VE303 and modulation of the microbiota and metabolites in healthy volunteers. Cell Host & Microbe. 2022 Apr 13;30(4):583–598.e8. doi:10.1016/j.chom.2022.03.016. PMID: 35421353.
   PubMed Web of Science ®Google Scholar