VE303 is an orally administered, rationally-designed, defined bacterial consortium candidate being developed for high-risk Clostridioides difficile (CDI) 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 CGMP conditions. It is produced under CGMP conditions from pure, clonal bacterial cell banks, which yield a standardized drug product in powdered form and bypasses the need to rely on direct sourcing of fecal donor material of inconsistent composition. 

In a Phase 2 study of patients at high risk of recurrence, VE303 met its primary endpoint of preventing C. difficile infection recurrence at eight weeks. This is the most advanced clinical trial of an investigational drug based on a rationally-designed bacterial consortium.

The Phase 2 study results have been published in JAMA. Results from the VE303 Phase 1 study have been published in Cell Host & Microbe.

Vedanta is currently enrolling patients into a Phase 3 registrational study of VE303 for the prevention of recurrent C. difficile infection. For more information about the study including contact details, please visit the RESTORATiVE303 study page at clinicaltrials.gov.