Vedanta Biosciences, a clinical-stage company developing a new category of therapies for immune-mediated diseases based on rationally-defined consortia of human microbiome-derived bacteria, today announced it has been awarded funding of $7.4 million, with the potential for up to an additional $69.5 million, from the Biomedical Advanced Research and Development Authority (BARDA) to advance clinical development of VE303 for high-risk Clostridioides difficile infection (CDI).
The funding will support completion of an ongoing Phase 2 trial and further clinical development of VE303, a rationally-defined, orally-administered live biotherapeutic product (LBP) consisting of eight well-characterized commensal bacterial strains designed to effect robust and durable therapeutic changes in a patient’s gut microbiota. A previous Phase 1a/1b study demonstrated rapid, durable, dose-dependent colonization and accelerated restoration of gut microbiota in healthy volunteers who were pretreated with antibiotics.
The ongoing Phase 2 study is a multi-center, randomized, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of two doses of VE303 compared to placebo in patients with high-risk CDI. The study is enrolling patients with a recent confirmed diagnosis of CDI who have completed a course of antibiotics but remain at high risk for recurrence. The primary endpoint is prevention of infection recurrence at eight weeks.
“We are honored to be the first-ever recipient of a BARDA award in the microbiome field and look forward to collaborating with the U.S. Government to advance the clinical development of VE303 and to potentially fulfill its promise in public health and biodefense,”
said Bernat Olle, Ph.D., co-founder and chief executive officer of Vedanta Biosciences.
“CDI accounts for approximately 12,800 deaths each year in the U.S. alone and are the result of damage to the gut microbiota caused by both necessary and unnecessary antibiotic use. We believe restoration of the gut microbiota after antibiotic use is a new paradigm in infection control that could improve patient outcomes following a broad range of procedures that rely on antibiotics, as well as a key underappreciated potential strategy in antimicrobial stewardship.”
BARDA, a division within the Office of the Assistant Secretary of Preparedness in the U.S. Department of Health and Human Services, supports a diverse portfolio of emerging therapeutics and devices. Programs supported by BARDA have received a total of 55 FDA approvals, licensures or clearances.
“The concept of rationally-designed live biotherapeutic products has strong merit for treating infectious diseases such as C. difficile,”
said Gary Disbrow, Ph.D., BARDA Acting Director.
“If successful, VE303 could prevent high-risk C. difficile and reduce our dependency on antibiotics, which would be a major win for public health. We’re enthusiastic about the opportunity to address both of these issues and proud to support clinical development of VE303.”
The grant from BARDA includes $7.4 million of guaranteed initial funding and up to an additional $69.5 million, subject to BARDA exercising multiple options under the award.
VE303 is an orally-administered, investigational live biotherapeutic product (LBP). It is produced from pure, clonal bacterial cell banks, which yield a standardized drug product in powdered form and bypasses the need to rely on direct sourcing of donor fecal material of inconsistent composition. VE303 consists of a defined consortium of live bacteria designed to restore colonization resistance against gut pathogens, including C. difficile. Vedanta Biosciences received a $5.4 million research grant from CARB-X in 2017 and a grant from BARDA in 2020 to support clinical studies of VE303. VE303 was granted Orphan Drug Designation in 2017 by the United States Food and Drug Administration (FDA) for the prevention of recurrent C. difficile infection (rCDI).