TIDMPRTC
PureTech Health PLC
30 June 2021
30 June 2021
PureTech Health plc
PureTech Founded Entity Vedanta Biosciences Announces New Data
from Phase 1 Study of VE202 for the Treatment of Inflammatory Bowel
Disease
The new data were presented at the International Human
Microbiome Consortium Congress 2021
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
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the
"Company"), a clinical-stage biotherapeutics company dedicated to
discovering, developing and commercializing highly differentiated
medicines for devastating diseases, is pleased to note that its
Founded Entity, Vedanta Biosciences, announced additional results
from a Phase 1 study in healthy volunteers of VE202, Vedanta'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).
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.
The full text of the announcement from Vedanta is as
follows:
Vedanta Biosciences Presents New Data from Phase 1 Study of
VE202, Its Rationally-Defined Consortium for the Treatment of
Inflammatory Bowel Disease, at the International Human Microbiome
Consortium Congress 2021 (IHMC)
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
CAMBRIDGE, MA, June 29, 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 the 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.
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated
to discovering, developing and commercializing highly
differentiated medicines for devastating diseases, including
inflammatory, fibrotic and immunological conditions, intractable
cancers, lymphatic and gastrointestinal diseases and neurological
and neuropsychological disorders, among others. The Company has
created a broad and deep pipeline through the expertise of its
experienced research and development team and its extensive network
of scientists, clinicians and industry leaders. This pipeline,
which is being advanced both internally and through PureTech's
Founded Entities, is comprised of 26 therapeutics and therapeutic
candidates, including two that have received FDA clearance and
European marketing authorization, as of the date of PureTech's most
recently filed Annual Report on Form 20-F. All of the underlying
programs and platforms that resulted in this pipeline of
therapeutic candidates were initially identified or discovered and
then advanced by the PureTech team through key validation points
based on the Company's unique insights into the biology of the
brain, immune and gut, or BIG, systems and the interface between
those systems, referred to as the BIG Axis.
For more information, visit www.puretechhealth.com or connect
with us on Twitter @puretechh.
Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that are or may be
forward-looking statements, including statements that relate to the
company's future prospects, developments, and strategies. The
forward-looking statements are based on current expectations and
are subject to known and unknown risks and uncertainties that could
cause actual results, performance and achievements to differ
materially from current expectations, including, but not limited
to, expectations regarding the potential of Vedanta's VE202 for the
treatment of IBD, expectations regarding the potential initiation
and expected timing of a Phase 2 study of VE202 in ulcerative
colitis, and those risks and uncertainties described in the risk
factors included in the regulatory filings for PureTech Health plc.
These forward-looking statements are based on assumptions regarding
the present and future business strategies of the company and the
environment in which it will operate in the future. Each
forward-looking statement speaks only as at the date of this press
release. Except as required by law and regulatory requirements,
neither the company nor any other party intends to update or revise
these forward-looking statements, whether as a result of new
information, future events or otherwise.
Contact:
Investors EU media
Allison Mead Talbot Ben Atwell, Rob Winder
+1 617 651 3156 +44 (0) 20 3727 1000
amt@puretechhealth.com ben.atwell@FTIconsulting.com
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