CAMBRIDGE, Mass. — Vedanta Biosciences raised $60 million to support a late-stage trial of its microbiome-based therapy for preventing recurrent Clostridioides difficile infection.
The funding includes a $40 million financing round led by existing investors AMR Action Fund and BNP Paribas Asset Management Alts. Vedanta raised approximately $18 million in the first quarter and another $22 million in the second quarter.
The company also received an additional $20 million from the U.S. Biomedical Advanced Research and Development Authority under an existing contract.
Vedanta plans to use the funding to complete the Phase 3 RESTORATiVE303 trial of VE303. The company expects to finish enrollment during the second half of 2026 and report topline efficacy results in the first half of 2027.
The trial has enrolled more than 80 percent of its planned participants and is being conducted at more than 150 sites across approximately 20 countries.
Earlier this year, an independent data monitoring committee recommended that the study continue without changes after a planned interim analysis. Vedanta said efficacy exceeded the study’s prespecified futility threshold and that no significant adverse events or new safety signals had emerged.
RESTORATiVE303 is evaluating VE303 in patients at high risk of recurrent C. difficile infection after antibiotic treatment. Participants are assigned in a 2-to-1 ratio to receive either a 14-day course of VE303 or a placebo.
The trial’s primary goal is to compare recurrence rates eight weeks after treatment. Vedanta intends to use the results to support a biologics license application to the U.S. Food and Drug Administration.
VE303 is an orally administered live biotherapeutic consisting of eight bacterial strains selected to restore balance in the gut microbiome.
Unlike microbiome treatments derived from donated fecal material, VE303 is manufactured from clonal bacterial cell banks to produce a standardized powdered drug product.
The FDA has granted VE303 orphan drug and fast-track designations.
Vedanta also announced two additions to its board of directors. Manos Perros, Ph.D., was appointed Executive Chairman, while Andrew Davis joined as an independent director.
Perros previously served as CEO of Entasis Therapeutics and held senior research and development positions at AstraZeneca, Novartis and Pfizer.
Davis is Chief Business and Strategy Officer at Convergent Therapeutics and previously held business development leadership roles at Dynavax, Ironwood Pharmaceuticals, iNova Pharmaceuticals and Bausch Health.
“We are grateful to our shareholders and BARDA for their continued support and pleased to welcome Manos and Andrew to the Vedanta Board of Directors,” founder and CEO Bernat Olle, Ph.D., said.
C. difficile is a potentially life-threatening gastrointestinal infection associated with antibiotic use. Patients who experience one episode face an increased risk of subsequent recurrences.
