RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED PHASE 2 STUDY OF VE202 IN PATIENTS WITH MILD-TO-MODERATE ULCERATIVE COLITIS

Brief description of study

VE202 is a rationally designed, live biotherapeutic product (LBP) for oral (po) administration that consists of 16 well-characterized, clonally-derived, nonpathogenic, nontoxigenic, commensal strains of Clostridia species. VE202 includes 12 strains from Clostridium cluster XIVa, 2 strains from cluster IV, and 2 strains from cluster XVIII. These bacteria, which were originally derived from the stool of a single healthy human, are obligate anaerobes that were selected for inclusion in the LBP based on individual strain- and consortia-specific properties that include association with healthy human gut microbiomes, promotion of colonic regulatory T (Treg) cells, production of beneficial and immunoregulatory metabolites, and lack of overt pathogenic or toxigenic features. The goal of treatment with VE202 is to restore the gut microbiome to a healthy and anti-inflammatory state in patients with UC via induction of immunoregulatory cells in the intestine, production of epithelium-protective metabolites, suppression of potentially inflammatory organisms, and maintenance of homeostatic signaling.


Clinical Study Identifier: s23-00089
ClinicalTrials.gov Identifier: NCT05370885
Principal Investigator: Jordan E Axelrad.
Other Investigators: Elie S Al Kazzi, Shannon Chang, Adam Faye, Simon J Hong, Ariela Holmer, David P Hudesman.


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