Poster presentations include mechanistic data from VE303 Phase 2 CONSORTIUM study that explore how VE303 prevents recurrence of Clostridioides difficile (C. diff) infection

A novel defined bacterial consortium, VE707 suppresses carriage of multidrug-resistant organisms (MDRO) in vivo and in vitro

Phase 3 pivotal study of VE303 initiation expected in the coming months and VE707 progressing toward clinical evaluation

Vedanta Biosciences, a clinical-stage company that is developing a potential new category of oral therapies based on defined bacterial consortia, today announced the details of two poster presentations at IDWeek 2023, being held virtually and in person in Boston, MA on October 11-15. The analyses cover two defined bacterial consortium candidates and include additional results from the VE303 Phase 2 CONSORTIUM study and an assessment of VE707 for the prevention of infection caused by multidrug-resistant Gram-negative bacteria. The posters will be presented at the session: “Antimicrobial Novel Agents” on Saturday, October 14, from 12:15 to 1:30 pm E.T.

“Vedanta has developed several rationally designed drug candidates that target the gut ecosystem, to prevent and treat serious diseases that result from carriage of bacterial pathogens in at-risk individuals. Among these are recurrent C. difficile and infections caused by multidrug-resistant organisms, which affect millions of patients around the world each year,” said Jeffrey Silber, M.D., Chief Medical Officer of Vedanta Biosciences. “We are pleased to share additional Phase 2 study data that further explain the biological effects of VE303 associated with prevention of C. difficile recurrence. VE303 accelerated the restoration of a healthy gut microbiome community and early recovery of key metabolites. Furthermore, among nearly 400 bacterial species detected in study participants after treatment, species in VE303 were the top predictors of non-recurrence. We look forward to initiating our global Phase 3 pivotal study of VE303, RestoratiVE303, in the coming months.”

“We are also sharing data on VE707, a preclinical stage defined consortium, which was highly efficacious at suppressing carriage of MDROs in animal models of gut colonization and was active in vitro against a broad panel of MDRO strains.”

VE303 is an orally administered defined bacterial consortium candidate that is being developed for prevention of recurrent C. difficile infection in those at high risk of recurrence. The VE303 Phase 2 data presented today indicate that VE303 works through multiple mechanisms to prevent recurrent C. difficile infection by restoring a healthy gut microbial community, decreasing inflammation, and increasing levels of protective metabolites. These findings build on previous analyses that demonstrated the clinical efficacy of VE303 and identified statistically significant relationships between colonization with VE303 strains and the observed efficacy.

Vedanta will also present preclinical data of VE707, a defined bacterial consortium candidate that is designed to decrease intestinal MDRO colonization. The MDROs that are targeted by VE707 are responsible for hundreds of thousands of infections in high-risk patients each year, with high associated mortality. Among nearly 100 consortia tested for their ability to reduce intestinal carriage of some of the most common and serious MDROs – carbapenem-resistant and extended-spectrum beta-lactamase-producing strains of Klebsiella pneumoniae and Escherichia coli – VE707 was the most effective at reducing the levels of K. pneumoniae and E. coli in rodent models, and demonstrated broad in vitro activity against a panel of 40 MDR clinical isolates of K. pneumoniae and E. coli. Additionally, Vedanta developed a co-culture process to enable commercially feasible manufacturing of VE707. Results from the preclinical studies demonstrate that a rationally designed, defined consortium of bacteria can decolonize MDROs in animals and can be manufactured efficiently.

Poster Presentations:

Title: Biological Features of Response to VE303, a Defined Bacterial Consortium, in Patients with Clostridioides Difficile Infection (CDI): Results of the Phase 2 Consortium Study

Presenter: Rajita Menon, Ph.D.

Title: VE707, a Defined Live Biotherapeutic Product for Prevention of Infection by Multidrug-Resistant Gram-Negative Bacteria

Presenter: Gregory Medlock, Ph.D.

About VE303

VE303 is a defined bacterial consortium therapeutic candidate designed for the prevention of recurrent Clostridioides difficile infection (rCDI). It consists of eight strains that were rationally selected using Vedanta’s discovery engine. VE303 is produced from pure, clonal bacterial cell banks, which yield a standardized drug product in powdered form and bypass the need to rely on direct sourcing of donor fecal material of inconsistent composition. Vedanta published study results in April 2023 from the Phase 2 CONSORTIUM trial, in which treatment with the VE303 high dose was associated with a 31.7% absolute risk reduction in the rate of recurrence when compared with placebo, representing a greater than 80% reduction in the odds of a CDI recurrence. Vedanta believes VE303 has the potential to become a first-in-class therapeutic based on a defined bacterial consortium. Vedanta Biosciences received a $5.4 million research grant from the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) in 2017. Additionally, the positive results of the Phase 2 study triggered a $23.8 million contract option from the Biomedical Advanced Research and Development Authority (BARDA) to support a Phase 3 clinical study of VE303. This project has been funded in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; BARDA, under contract number 75A5012C00177 for a contract value up to $81.9 million. VE303 was granted Orphan Drug Designation in 2017 and Fast Track Designation in 2023 by the U.S. Food and Drug Administration (FDA) for the prevention of recurrent CDI.

About VE707

VE707 is a preclinical defined bacterial consortium therapeutic candidate for the prevention of infection and colonization recurrence of several MDROs, including carbapenem-resistant Enterobacteriaceae (CRE) and extended-spectrum beta-lactamase (ESBL) producers. CRE, ESBL producers, and VRE are some of the most common causes of hospital-acquired infections and are estimated to affect over 500,000 intensive care unit, dialysis, solid organ transplant, and hematopoietic stem cell transplant patients each year in the U.S. and Europe. Infections with these organisms can result in life-threatening treatment delays or death, and result in approximately $2 billion healthcare-associated costs due to patient isolation practices alone.

About Vedanta Biosciences

Vedanta Biosciences is leading the development of a potential new category of oral therapies based on defined consortia of bacteria isolated from the human microbiome and grown from pure clonal cell banks. The company’s pipeline includes clinical-stage product candidates being evaluated for the prevention of recurrent C. difficile infection and inflammatory bowel diseases and a preclinical candidate for the prevention of Gram-negative infections. In addition, the company supports investigator-sponsored studies in various diseases. These investigational therapies are grounded in our team’s pioneering research – published in leading journals including Science, Nature, Cell, and JAMA – to identify beneficial bacteria that live symbiotically within the healthy human gut, fight pathogens, and induce a range of potent immune responses. Vedanta Biosciences controls a foundational portfolio of more than 70 patents and has built what it believes is the industry-leading platform for development of defined bacterial consortia drugs. This platform includes one of the largest libraries of bacteria derived from the human microbiome, vast datasets from human interventional studies, proprietary capabilities in consortium design, and end-to-end capabilities for CGMP-compliant manufacturing of oral drug candidates spanning cell banking, fermentation, lyophilization, and fill finish.

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