CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vedanta Biosciences, a leading 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 that additional pharmacokinetics data from a Phase 1 clinical study of VE202 in healthy volunteers will be presented by Janssen Research & Development, LLC, at United European Gastroenterology (UEG) Week 2020, held virtually from October 11-13.
Topline data from placebo-controlled Phase 1 studies were announced in June which reported that VE202 was generally well-tolerated at all doses studied. The new UEG Week data presentation focuses on the kinetics and durability of colonization from an 11-strain consortium of VE202 under various dosing and pre-treatment regimens.
“People living with inflammatory bowel disease often struggle to find lasting relief with currently available medications. Our defined bacterial consortia are designed to reshape the ecosystem of the gut microbiome, an aspect of inflammatory bowel disease (IBD) that has not been addressed by biologics and other existing drug classes,” said Bernat Olle, Ph.D., co-founder and chief executive officer of Vedanta Biosciences. “We are encouraged by these results and look forward to further advancing VE202 to patient studies.”
Vedanta plans to take the VE202 program forward into a Phase 2 study in inflammatory bowel disease in 2021.
The data presented at UEG Week focus on 74 healthy volunteers treated with an 11-strain consortium of VE202 or a placebo. Results include:
- The consortium colonized the gut abundantly and above background strains detected by qPCR. Colonization was most effective with vancomycin pre-treatment followed by multiple doses of the consortium. In multiple-day dosing cohorts, vancomycin pretreatment reduced microbial density and was required for sustained detection of VE202 compared to non-vancomycin pre-treated cohorts. In these cohorts, VE202 strains were detected up to six months post-treatment.
- Vedanta is currently conducting metagenomic and metabolomic profiling to further characterize the mechanisms by which VE202 impacts microbiome community structure in addition to measuring metabolites, and the results will be presented in future publications.
About Inflammatory Bowel Disease
Inflammatory bowel disease (IBD) is estimated to affect approximately three million people in the United States, with as many as 70,000 new cases of the diseases diagnosed each year. IBD is believed to result from interactions between generic factors and environmental triggers, such as commensal bacteria with pathogenic potential. It is associated with chronic inflammation in the gastrointestinal (GI) tract, impairing the ability of affected GI organs to function properly. Symptoms can vary but include diarrhea, abdominal pain, cramping, rectal bleeding and fatigue. Patients often endure debilitating cycles of flare-ups and disease progression and may struggle to find a treatment that durably addresses their symptoms.
About VE202
VE202 is a first-in-class orally-administered investigational live biotherapeutic product (LBP) consisting of a defined bacterial consortium. It is produced under GMP conditions 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 fecal donor material of inconsistent composition. VE202 was designed to induce immune tolerance via the gut and thereby potentially treat inflammatory bowel disease. Results describing the biology and candidate selection of VE202 were previously published in Science and Nature (multiple).
About Vedanta Biosciences
Vedanta Biosciences is leading the development of a potential new category of oral therapies based on rationally defined consortia of bacteria derived from the human microbiome. The company’s clinical-stage pipeline includes product candidates being evaluated for the treatment of high-risk C. difficile infection, inflammatory bowel diseases, advanced or metastatic cancers, and food allergy. These investigational therapies are grounded in pioneering research – published in leading journals including Science, Nature, and Cell – 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 40 patents and has built what is believed to be the world’s biggest library of bacteria derived from the human microbiome. Proprietary capabilities include deep expertise in consortium design, vast datasets from human interventional studies and cGMP-compliant manufacturing of oral live biotherapeutics containing pure, clonally derived bacterial consortia in powdered form. Vedanta Biosciences was founded by PureTech Health (LSE:PRTC) and a global team of scientific co-founders who pioneered Vedanta’s modern understanding of the cross-talk between the microbiome and the immune system.
