VE-818: An Investigational Live Biotherapeutic Product for Intestinal Diseases

I. Executive Summary

VE-818 is an investigational live biotherapeutic product (LBP) originated and currently under development by Vedanta Biosciences, Inc..[1] This product is classified within the "Bacteria" therapeutic class and is designed to function through mechanisms described as "Bacteria replacements" and "Gastrointestinal microbiome modulators".[1]

The development of VE-818 has advanced to Phase 2 clinical trials, with a primary focus on addressing intestinal diseases.[1] Notably, current Phase 2 investigations are specifically evaluating the potential of VE-818 to reduce enteropathogen colonization and ameliorate environmental enteropathy in pregnant women, a significant area of unmet medical need in certain global regions.[1]

Findings from Phase 1 clinical studies, conducted in healthy adult volunteers, indicated that VE-818 was well tolerated. These initial studies provided crucial insights into its clinical pharmacology, demonstrating that robust colonization of the gut by the VE-818 bacterial strains could be achieved, particularly when preceded by vancomycin pretreatment. The persistence of this colonization was also found to be influenced by the duration of VE-818 administration. A key pharmacodynamic observation from these early trials was an association between VE-818 administration and an increase in stool concentrations of secondary bile acids, metabolites known for their immunoregulatory functions.[3]