Vedanta Biosciences Presents New Data from Phase 1 Study of VE202, Its Rationally-Defined Consortium for the Treatment of Inf...
30 June 2021 - 6:01AM
Business Wire
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 27-29th.
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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Investors and Media Chris Brinzey +1 617 835 9304
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