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. 2022 Apr 13;30(4):583-598.e8.
doi: 10.1016/j.chom.2022.03.016.

Colonization of the live biotherapeutic product VE303 and modulation of the microbiota and metabolites in healthy volunteers

Melissa Dsouza  1 , Rajita Menon  1 , Emily Crossette  1 , Shakti K Bhattarai  2 , Jessica Schneider  1 , Yun-Gi Kim  1 , Shilpa Reddy  1 , Silvia Caballero  1 , Cintia Felix  1 , Louis Cornacchione  1 , Jared Hendrickson  1 , Andrea R Watson  1 , Samuel S Minot  3 , Nick Greenfield  4 , Lisa Schopf  1 , Rose Szabady  1 , Juan Patarroyo  1 , William Smith  1 , Pratibha Harrison  5 , Ed J Kuijper  6 , Ciaran P Kelly  7 , Bernat Olle  1 , Dmitri Bobilev  1 , Jeffrey L Silber  1 , Vanni Bucci  2 , Bruce Roberts  1 , Jeremiah Faith  8 , Jason M Norman  9
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Free article

Colonization of the live biotherapeutic product VE303 and modulation of the microbiota and metabolites in healthy volunteers

Melissa Dsouza et al. Cell Host Microbe. .
Free article

Abstract

Manipulation of the gut microbiota via fecal microbiota transplantation (FMT) has shown clinical promise in diseases such as recurrent Clostridioides difficile infection (rCDI). However, the variable nature of this approach makes it challenging to describe the relationship between fecal strain colonization, corresponding microbiota changes, and clinical efficacy. Live biotherapeutic products (LBPs) consisting of defined consortia of clonal bacterial isolates have been proposed as an alternative therapeutic class because of their promising preclinical results and safety profile. We describe VE303, an LBP comprising 8 commensal Clostridia strains under development for rCDI, and its early clinical development in healthy volunteers (HVs). In a phase 1a/b study in HVs, VE303 is determined to be safe and well-tolerated at all doses tested. VE303 strains optimally colonize HVs if dosed over multiple days after vancomycin pretreatment. VE303 promotes the establishment of a microbiota community known to provide colonization resistance.

Keywords: C. difficile infection; antibiotics; live biotherapeutic product; metabolites; metagenomics; microbiome; pharmacology.

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Conflict of interest statement

Declaration of interests R.M., S.R., E.C., S.C., J.H., C.F., L.C., A.R.W., J.L.S., B.O., and J.M.N. are employees of Vedanta Biosciences and have an equity interest in the company. Vedanta Biosciences holds patents related to this work. M.D., J.S., Y.-G.K., J.P., L.S., R.S., W.S., D.B., and B.R. were employees of Vedanta Biosciences and had an equity interest in the company at the time of their contribution. J.F. is a member of the scientific advisory board of Vedanta Biosciences and has an equity interest in the company. The authors vouch for the accuracy and completeness of the data and data analyses. This content is solely the responsibility of the authors and does not necessarily represent the official views of the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response.

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