Vedanta Biosciences has secured $60 million in funding to advance its pivotal Phase 3 RESTORATiVE303 study evaluating VE303 for the prevention of recurrent Clostridioides difficile infection. The financing includes a $40 million investment round led by existing investors AMR Action Fund and BNP Paribas Asset Management Alts. Vedanta received approximately $18 million during the first quarter and another $22 million during the second quarter.
The company also received an additional $20 million through its existing contract with the Biomedical Advanced Research and Development Authority, or BARDA.
Vedanta plans to use the funding to support RESTORATiVE303, which recently surpassed 80% enrollment. The company expects to complete enrollment during the second half of 2026 and report topline efficacy data in the first half of 2027.
An independent Data Monitoring Committee completed the trial’s first prespecified interim analysis earlier this year and recommended that the study continue without modification. The committee determined that efficacy results exceeded the study’s prespecified futility threshold and found no significant adverse events or new safety signals.
RESTORATiVE303 is enrolling patients at more than 150 sites across approximately 20 countries. The randomized, double-blind and placebo-controlled study is evaluating VE303 in patients at high risk of recurrent C. difficile infection after antibiotic treatment.
Participants are randomized on a two-to-one basis to receive a 14-day course of VE303 or a matching placebo. The primary endpoint measures the recurrence rate at eight weeks.
Vedanta intends for the study to support a future Biologics License Application to the U.S. Food and Drug Administration.
VE303 is an orally administered live biotherapeutic consisting of eight bacterial strains selected through Vedanta’s development platform. The product is manufactured using clonal bacterial cell banks rather than donor fecal material, which is intended to create a more standardized therapy.
The FDA granted VE303 Orphan Drug Designation in 2017 and Fast Track Designation in 2023.
Vedanta also appointed Manos Perros as Executive Chairman and Andrew Davis as an independent director in connection with the financing.
Perros previously served as CEO of Entasis Therapeutics and held senior positions at AstraZeneca, Novartis and Pfizer. Davis is Chief Business and Strategy Officer at Convergent Therapeutics and previously held leadership roles at Dynavax, Ironwood Pharmaceuticals, iNova Pharmaceuticals and Bausch Health.
KEY QUOTE:
“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. Manos and Andrew bring a wealth of experience in development and regulatory approval of innovative drugs as well as execution of strategic transactions.”
Bernat Olle, Ph.D., Founder and CEO of Vedanta Biosciences
