Vedanta Biosciences reveals Phase 2 VE303 results

Study highlights VE303’s potential in reducing recurrent CDI

Vedanta Biosciences has published additional results from its Phase 2 CONSORTIUM study for VE303, a potential first-in-class Live Biotherapeutic Product for preventing recurrent Clostridioides difficile infection (rCDI). The study showed VE303 was well tolerated and significantly reduced CDI recurrence odds.

VE303, consisting of a defined consortium of eight bacterial strains, demonstrated over 80% reduction in CDI recurrence compared to placebo. VE303 organisms colonised the gut rapidly in a dose-dependent manner, linking colonisation to greater recurrence-free probability.

“This clinical research offers new insights into VE303’s mechanisms, providing a rationale for its protective effects,” said Bernat Olle, Ph.D., CEO of Vedanta Biosciences. VE303’s defined composition allows rigorous study of its mechanisms, contributing to a better understanding of microbiome restoration interventions.

The publication highlights VE303’s multi-mechanistic approach, including restoring healthy gut microbiota, decreasing inflammation, and increasing protective metabolites. Specific strains’ abundance predicted recurrence-free outcomes, indicating efficacy from strains working together.

Vedanta plans to use these results to inform the Phase 3 RESTORATiVE303 study design, expected to yield topline data in 2026. VE303’s potential in reducing CDI recurrence is further supported by these findings, guiding future clinical and regulatory decisions.

“This line of work helps fill a knowledge gap in the field,” said Olle. The research also emphasised the importance of short-chain fatty acids and key secondary bile acids, beneficial in conferring resistance to CDI.

Vedanta Biosciences is committed to advancing VE303, with the ongoing Phase 3 trial aiming to confirm its efficacy and safety profile. This project is partly supported by federal funds from the Department of Health and Human Services, BARDA, under contract number 75A50120C00177.