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.
CONSORTIUM is currently enrolling participants across North America (U.S. and Canada) who have been diagnosed with recurrent CDI.
For additional study information or to locate a study site near you, please visit Clinicaltrials.gov:
If you have questions about the study or are interested in study participation, please email: