RESTORATiVE303

Trial overview:

• VE303 is administered in oral capsules
• Each capsule contains 8 well-characterized commensal bacterial strains that are grown from pure clonal cell banks

Stage 1

• 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

Stage 2 is not yet open for enrollment

• Stage 2 will enroll participants with primary CDI who are at high risk of developing a recurrence.

For more information about the RESTORATiVE303 study, including contact details, please visit our study page at clinicaltrials.gov.

Previous VE303 trials

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. Administration of VE303 was associated with a CDI recurrence rate of 13.8% compared with 45.5% for placebo, which represents a greater than 80% reduction in the odds of a CDI recurrence.

Additionally, VE303 was observed to be generally well-tolerated; none of the serious treatment-emergent adverse events was determined to be related to the study drug.

For additional information on the Phase 2 study, please visit our study page at clinicaltrials.gov.