Vedanta is currently enrolling participants into a Phase 3 study of VE303 for patients with recurrent Clostridioides difficile infection (rCDI).
RESTORATiVE303 is a double-blind, placebo-controlled, Phase 3 study to evaluate the safety and efficacy of a 14-day course of VE303. The efficacy of VE303 will be assessed by comparing the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in study participants who receive VE303 and those who receive placebo.
- VE303 is administered in oral capsules that contain 8 well-characterized, nonpathogenic, nontoxigenic, commensal bacterial strains that are grown from pure clonal cell banks. The strains were originally identified from healthy humans.
- Stage 1 of the study is targeting enrollment of 420 people, age 12 years and older, in more than 20 countries.
- For those who meet all eligibility criteria and choose to enroll, participation in the study will last 24 weeks.
- Participants must have:
- Recent onset of diarrhea and a laboratory-confirmed diagnosis of rCDI, and
- At least 1 prior episode of CDI within the last 6 months.
- Study participants will be randomly assigned to one of two groups in a 2:1 ratio.
- Participants who experience an on-study CDI recurrence will have the option to receive an open-label course of treatment with VE303 for 14 days.
- Stage 2 will enroll participants with primary CDI who are at high risk of developing a recurrence. Stage 2 is not yet open for enrollment.
For more information about the RESTORATiVE303 study, including contact details, please visit clinicaltrials.gov at https://clinicaltrials.gov/ct2/show/NCT06237452.
Previously, in the CONSORTIUM study, a randomized, double-blind, Phase 2 trial in patients at high risk of CDI recurrence, VE303 met its primary efficacy endpoint of preventing CDI recurrence at Week 8, and was observed to be generally well-tolerated.
For additional information on the Phase 2 study, please visit clinicaltrials.gov at https://www.clinicaltrials.gov/ct2/show/NCT03788434.