Topline Data of Investigator-Sponsored Study of VE303 to Treat Hepatic Encephalopathy (HE) Presented at The Liver Meeting 2023
CAMBRIDGE, MA, November 13, 2023 – Vedanta Biosciences, a clinical-stage company that is developing a potential new category of oral therapies based on defined bacterial consortia, today announced details of a late-breaker poster presentation summarizing the results of an investigator-sponsored, randomized, placebo-controlled Phase 2a study of VE303 as a potential treatment for patients with hepatic encephalopathy (HE). The poster is being presented by the study’s Principal Investigator in Boston, MA at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which is commonly known as “The Liver Meeting”.
The study, conducted at the University of Michigan Hospitals, evaluated the safety, colonization dynamics, and efficacy of VE303 versus placebo as an add-on to lactulose plus rifaximin, a standard treatment for HE. The study enrolled 18 patients, who were randomized in a 2:1 ratio to receive 14 days of VE303 or placebo. The primary efficacy endpoint was the change in psychometric HE score (PHES) from baseline to four weeks post-treatment (study week 6) in the two treatment groups. PHES is a validated method, using a battery of five paper-pencil tests that evaluate cognitive and psychomotor processing speed and visuomotor coordination in patients with HE. Follow-up for safety, including reporting of all HE-related hospitalizations, continued for six months.
Topline results from the study showed that VE303 had an acceptable overall safety and tolerability profile. The VE303 group had an improvement in PHES from baseline to post-treatment, with a mean change (standard deviation) of +1.5 (3.5) points, versus a decline in the placebo recipients, who had a mean change of -1.0 (3.7) points; p=0.20. Four subjects in the VE303 group, versus one in the placebo group, experienced one or more HE-related hospitalizations during the study. Of note, despite randomization, participants in the VE303 group were observed to have more advanced HE at baseline than those in the placebo group, based on baseline PHES and number of hospitalizations for HE in the 12 months prior to study enrollment. Additional analyses of the study data are underway.
Late-Breaker Poster Presentation:
Title: Trial of a Defined Bacterial Consortium, VE303, to Treat Hepatic Encephalopathy
Presenter: Patricia P. Bloom, MD, Assistant Professor of Medicine, University of Michigan Medical School
Date and Time: Monday, November 13 at 1:00 PM EST
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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