Vedanta Biosciences has secured $60 million to advance the Phase 3 RESTORATiVE303 trial of VE303, an investigational live biotherapeutic for preventing recurrent Clostridioides difficile infection, with topline data expected in 2027.
Written By: Meghana Jinka, PharmD
Reviewed By: Pharmacally Editorial Team
Vedanta Biosciences has secured $60 million in funding to advance the late-stage development of VE303, an investigational oral live biotherapeutic for preventing recurrent Clostridioides difficile infection (CDI). The funding will support completion of the pivotal Phase 3 RESTORATiVE303 trial, with enrollment expected to conclude in the second half of 2026 and topline efficacy data anticipated in the first half of 2027.
VE303 Targets the Underlying Microbiome Disruption in Recurrent CDI
VE303 is an orally administered live biotherapeutic product comprising a defined consortium of eight bacterial strains selected through Vedanta’s microbiome discovery platform. Unlike fecal microbiota-based therapies, VE303 is manufactured from pure clonal bacterial cell banks, producing a standardized powdered formulation without relying on donor-derived fecal material.
The investigational therapy has received FDA Orphan Drug Designation in 2017 and Fast Track Designation in 2023.
Recurrent CDI remains a major healthcare challenge. Up to 175,000 people in the United States develop recurrent infection each year, contributing to approximately 20,000 deaths annually. Each recurrence further increases the risk of future episodes, prolonged hospitalization, and reduced quality of life, highlighting the need for therapies that restore the disrupted gut microbiome.
Phase 3 RESTORATiVE303 Trial Passes 80% Enrollment
RESTORATiVE303 (NCT06237452) is a randomized, double-blind, placebo-controlled, multinational Phase 3 study evaluating VE303 in patients at high risk of recurrent CDI following antibiotic treatment for a previous infection.
More than 150 clinical sites across approximately 20 countries are participating in the study. Eligible participants are randomized in a 2:1 ratio to receive either a 14-day course of VE303 or matching placebo.
The primary endpoint is recurrence of CDI through Week 8. The trial includes patients experiencing recurrent CDI, including many with a first recurrence and a substantial proportion treated with fidaxomicin during their qualifying infection, reflecting current standards of care.
Earlier this year, an independent Data Monitoring Committee completed the first prespecified interim analysis and recommended that the study continue without modification after determining that efficacy exceeded the predefined futility threshold and that no significant adverse events or new safety signals had emerged.
If successful, RESTORATiVE303 is expected to support a Biologics License Application (BLA) submission to the U.S. Food and Drug Administration.
Leadership Expansion Supports Late-Stage Development
Alongside the financing, Vedanta appointed Manos Perros, Ph.D., as Executive Chairman of the Board and named Andrew Davis as an independent Board Director.
Perros previously served as Chief Executive Officer of Entasis Therapeutics, where he oversaw development of Xacduro for Acinetobacter baumannii pneumonia and Nuzolvence, an oral antibiotic for gonorrhea. He has also held senior research and development leadership positions at AstraZeneca, Novartis, and Pfizer, including leadership of the program that resulted in FDA approval of the HIV therapy Selzentry.
Davis brings more than 20 years of business development and strategic transaction experience across the biopharmaceutical industry. His previous leadership roles include Dynavax, Ironwood Pharmaceuticals, iNova Pharmaceuticals, and Bausch Health, where he led several major acquisitions in infectious disease and gastroenterology.
Vedanta founder and Chief Executive Officer Bernat Olle, Ph.D., said the continued support from investors and BARDA will enable completion of the Phase 3 program while strengthening the company’s leadership as it prepares for potential regulatory submission and commercialization of VE303.
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About the Writer
Meghana Jinka (LinkedIn) is a Pharm.D graduate with a strong interest in clinical pharmacy, clinical research, pharmacovigilance, and medical writing. She has developed expertise in evaluating scientific literature, interpreting clinical data, and communicating complex medical information in a clear and accessible manner. Through clinical training, patient counseling, and healthcare awareness activities, she has gained practical experience in evidence-based medicine and patient-centered care. Passionate about healthcare communication, Meghana is committed to developing accurate, engaging, and evidence-based healthcare documents that support healthcare professionals and the wider community.