VE303 is an orally administered, rationally-defined bacterial consortium candidate being developed for high-risk Clostridioides difficile (CDI) infection. VE303 consists of 8 types of clonal human commensal bacteria strains selected for their ability to provide colonization resistance to C. difficile and manufactured under cGMP conditions. It is produced under cGMP conditions from pure, clonal bacterial cell banks, which yield a standardized drug product in powdered form and bypasses the need to rely on direct sourcing of fecal donor material of inconsistent composition.
In a Phase 1a/1b clinical trial in healthy volunteers, VE303 showed rapid, durable and dose-dependent colonization and accelerated gut microbiota restoration after a course of antibiotics. Vedanta is currently evaluating VE303 in a Phase 2 clinical trial in patients at high risk of recurrent C. difficile infection, with results anticipated in 2021.