Results further support the benign safety profile of VE202 and identify an optimal dosing regimen

Vedanta plans to initiate a Phase 2 clinical trial of VE202 in ulcerative colitis patients in the second half of 2021

Vedanta Biosciences, a leading clinical-stage microbiome company developing a new category of oral therapies using defined bacterial consortia manufactured from clonal cell banks, today announced additional results from a Phase 1 study in healthy volunteers of VE202, the Company’s 16-strain live biotherapeutic product (LBP) candidate for inflammatory bowel disease (IBD). The new data were presented at the International Human Microbiome Consortium Congress 2021 (IHMC), being held virtually from June 27-29^th.

Topline data from two Phase 1 studies exploring 11- and 16-strain VE202 consortia were announced in June 2020. The new data presented at IHMC summarized the long-term safety and colonization dynamics of the 16-strain version of VE202 in 31 healthy volunteers. Vedanta plans to move this consortium forward to a Phase 2 study in patients with ulcerative colitis. The study will be partially funded with proceeds from a $25 million investment from Pfizer, as part of the Pfizer Breakthrough Growth Initiative, which was announced in January 2021.

Key takeaways from the study include:

• All doses of the 16-strain consortium were generally safe and well-tolerated, with no reports of VE202-related serious adverse events.
• Multiple-day dosing proved superior to single-day dosing for inducing durable colonization; following 14 days of treatment, all or most of the LBP strains were detected in all VE202 recipients through the final study visit at Week 24.
• Colonization was abundant and durable; at the final study visit at Week 24, relative abundance of VE202 strains remained almost 100-fold higher than at baseline
• Colonization was most effective when oral vancomycin pre-treatment preceded multiple doses of VE202.
• The results of this study corroborate the findings from other Phase 1 studies using Vedanta’s defined consortia and provide a framework to rationally select an optimal dose regimen for Phase 2 studies.

“Approximately 3 million people in the U.S. alone are affected by IBD, with another estimated 70,000 newly diagnosed cases each year. Although a number of treatments exist, they are limited and patients with IBD 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 IBD that has not been addressed by biologics or 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 advancing VE202 into Phase 2 clinical trials.”

Vedanta plans to initiate a Phase 2 clinical trial of VE202 in patients with mild to moderate ulcerative colitis in the second half of 2021.

About VE202

VE202 is a first-in-class, orally administered, investigational LBP consortium consisting of 16 bacterial strains of the Clostridia class, which were rationally selected to induce immune tolerance in the gut, reverse the gut microbiota abnormalities that are common in patients with IBD, and strengthen the epithelial barrier. Results describing the biology and candidate selection of VE202 were previously published in Science and Nature (multiple).

About Inflammatory Bowel Disease

Inflammatory bowel disease (IBD) is a debilitating, life-long condition that results from chronic inflammation of the intestinal tract. The most common forms of IBD are ulcerative colitis and Crohn's disease, which are both characterized by diarrhea, rectal bleeding, abdominal pain, fatigue and weight loss that can lead to life-threatening complications due to chronic inflammation of the digestive tract. Although the exact cause of IBD is not entirely understood, IBD is known to involve an interaction between genes, environmental factors, and dysregulation of the immune system, resulting in chronic inflammation. The CDC estimates that IBD affects an estimated 1.3% of adults in the United States, or approximately 3 million people.

About Vedanta Biosciences

Vedanta Biosciences is leading the development of a potential new category of oral therapies for immune-mediated diseases using defined bacterial consortia manufactured from clonal cell banks. The Company’s approach bypasses the need to rely on direct sourcing of donor fecal material of inconsistent composition, thus overcoming challenges related to safety, quality, and scalability that limit donor-derived approaches. The clinical pipeline includes product candidates being evaluated for the treatment of 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 – that identified bacteria that induce a range of beneficial immune responses. The Company’s platform includes what is believed to be the largest library of bacteria derived from the human microbiome, high-throughput methods for bacterial consortium design, vast datasets from human interventional studies, and state-of-the-art capabilities for cGMP-compliant manufacturing of defined bacterial consortia. Vedanta Biosciences controls a foundational intellectual property portfolio covering compositions of matter and methods of use for classes of bacteria that play key roles in human health. Vedanta Biosciences was founded by PureTech Health (Nasdaq: PRTC, LSE: PRTC) and a global team of scientific co-founders who pioneered the modern understanding of the interaction between the immune system and the microbiome.

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