VE303 is a rationally-defined bacterial consortium candidate being developed for the prevention of recurrent C. difficile infection. VE303 consists of 8 types of clonal human commensal bacteria strains selected for their ability to provide colonization resistance to C. difficile and manufactured under GMP conditions.
In a Phase 1 study in healthy volunteers, VE303 showed rapid, abundant, durable , and dose-dependent colonization and accelerated microbiota recovery after a course of antibiotics. Vedanta is currently evaluating VE303 in a Phase 2 clinical study (CONSORTIUM) in patients with recurrent C. difficile infection.
CONSORTIUM (NCT03788434) is a randomized, double-blind phase 2 study to evaluate safety, tolerability, PK/PD, and efficacy of VE303 in 146 adult subjects with 1 or more recurrences of Clostridium difficile infection (CDI), including the current episode. The primary endpoint is the proportion of subjects experiencing a confirmed CDI recurrence within 8 weeks after the first dose of study treatment.
For additional study information visit Clinicaltrials.gov: