Vedanta raises $60M to advance Phase III trial of microbiome therapy VE303

Vedanta raises $60M to advance Phase III trial of microbiome therapy VE303

Vedanta Biosciences has secured $60 million to support the Phase III development of VE303, its microbiome-based therapy designed to prevent recurrent Clostridioides difficile infection (CDI).

The financing consists of a $40 million investment and a further $20 million grant from the U.S. Biomedical Advanced Research and Development Authority (BARDA).

What is VE303?

VE303 is an oral live biotherapeutic consisting of eight selected bacterial strains. It is designed to restore the gut microbiome following antibiotic treatment and reduce the risk of C. difficile infection returning.

Unlike conventional faecal microbiota transplantation, VE303 is manufactured from standardized clonal bacterial cell banks rather than directly from donor stool, allowing for a more controlled and consistent product composition.

The Phase III RESTORATiVE303 trial is expected to enrol approximately 852 patients. Its primary endpoint will compare the rate of CDI recurrence within eight weeks of treatment with VE303 versus placebo.

In an earlier Phase II study, CDI recurrence through week eight was 13.8% in the high-dose VE303 group compared with 45.5% in the placebo group.

Topline Phase III efficacy results are expected in the first half of 2027.