In a Phase 1a/1b clinical trial in healthy volunteers, VE303 treatment resulted in rapid, durable, dose-dependent colonization and accelerated gut microbiota restoration after a course of antibiotics. Vedanta is currently evaluating VE303 in a Phase 2 clinical study (CONSORTIUM) in patients with high-risk Clostridioides difficile infection (CDI).
CONSORTIUM (NCT03788434) is a randomized, double-blind Phase 2 study to evaluate safety, tolerability, pharmacokinetic/pharmacodynamic (PK/PD) and efficacy of VE303 in patients with a recent diagnosis of CDI, who have completed a course of antibiotics but remain at risk for recurrence. The primary endpoint will be prevention of infection recurrence at eight weeks.
CONSORTIUM is currently enrolling participants across North America (U.S. and Canada) who have been diagnosed with high-risk 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: