VE416 is an orally administered, rationally-designed, defined bacterial consortium candidate being developed for the potential treatment of food allergy. VE416 consists of clonal human commensal bacterial strains selected for their ability to suppress allergic responses and manufactured under cGMP conditions. It is produced from pure, non-pathogenic clonal bacterial cell banks, which yield a standardized drug product in powdered form.
In July 2019, Vedanta announced the first patient was enrolled in the Phase 1/2 clinical study of VE416, which is being conducted by Wayne Shreffler, M.D., Ph.D., chief of pediatric allergy and immunology and director of the Food Allergy Center at Massachusetts General Hospital. The study will explore VE416 both as a monotherapy and in combination with an oral peanut immunotherapy over the course of several months. Topline data are expected in 2023.