The Phase 1/2 study of VE416 is a randomized, double-blind, placebo-controlled trial of Vedanta’s live biotherapeutic product candidate being developed for treatment of food allergies, beginning with peanut allergy. The study, 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, at MassGeneral Hospital for Children, will enroll up to 40 patients who are 12 years of age and older and explore VE416 both as a monotherapy and in combination with an oral peanut immunotherapy over the course of several months. The primary endpoints are the safety of VE416 and the amount of peanut protein tolerated during a double-blind, placebo-controlled food challenge following the treatment.
For additional study information or to locate a study site near you, please visit Clinicaltrials.gov: