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2021-10-07| Special

BARDA Exercises $23.8 Million to Support Phase 3 Trial of Vedanta’s Encouraging Microbiome Therapy

by Manju Bhaskar
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Recurrent Clostridium difficile infection (CDI) causes approximately half a million infections each year in the US, including up to 165,000 recurring infections and up to 45,000 deaths. Although several antibiotics are approved to treat CDI, recurrence occurs frequently and is a major cause of morbidity and mortality. Both CDI recurrence and infection by a variety of other bacterial species could encourage the spread of antibiotic resistance.

On October 5th, Vedanta Biosciences, a clinical-stage company, announced the positive results of the Phase 2 clinical trial of VE303, a potential new tool against CDI. VE303 is an orally administered, investigational live biotherapeutic product (LBP) in development for the prevention of recurrent CDI in patients at high risk for recurrence.

These encouraging outcomes have triggered a $23.8 million contract option from the Biomedical Advanced Research and Development Authority (BARDA) to support a Phase 3 clinical trial of VE303, which Vedanta plans to initiate in 2022.

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