VE202 is an orally administered rationally-defined bacterial consortium candidate being developed for the potential treatment of inflammatory bowel disease (IBD). VE202 consists of clonal human commensal bacteria strains selected for their ability to impact the number and activity of regulatory T cells in the gut mucosa and manufactured under cGMP conditions. It is produced from pure, clonal cell banks, which yield a standardized drug product in powder form and bypass the need to rely on direct sourcing of fecal donor material of inconsistent composition. The foundational research underlying VE202 led by Vedanta Biosciences’ co-founder Kenya Honda, M.D., Ph.D. of Keio University School of Medicine was published in Science and two additional publications in Nature (Atarashi et al. 2013; Furusawa et al. 2013)
In June 2020, Vedanta announced positive topline data from two Phase 1 studies of VE202. VE202 was generally safe and well tolerated at all doses and demonstrated durable and dose-dependent colonization. Vedanta expects to begin a Phase 2 study in IBD patients in 2021.