TIDMPRTC
PureTech Health PLC
12 October 2020
12 October 2020
PureTech Health plc
PureTech Founded Entity Vedanta Biosciences Announces Additional
Pharmacokinetics Data from Phase 1 Study of VE202 for Inflammatory
Bowel Disease to be Presented at United European Gastroenterology
Week 2020
Data to be presented showing VE202 microbiome-derived bacterial
strains rapidly, abundantly and durably colonise the gut of healthy
volunteers
PureTech Health plc (LSE: PRTC) ("PureTech" or the "Company"), a
clinical-stage biotherapeutics company dedicated to discovering,
developing and commercialising highly differentiated medicines for
devastating diseases, is pleased to note that its Founded Entity,
Vedanta Biosciences, today announced t hat 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 colonisation
from an 11-strain consortium of VE202 under various dosing and
pre-treatment regimens.
Bharatt Chowrira, JD, PhD, PureTech's president and chief of
business and strategy, said: "These additional Phase 1 data are
important, as sustained and durable colonisation of the healthy
human gut suggests that VE202 is having the desired effect. The
findings further validate Vedanta's unique and differentiated
approach to developing microbiome-based products and support the
potential of VE202 as a novel treatment for inflammatory bowel
disease (IBD). We're pleased that Vedanta will continue to progress
the programme into a Phase 2 study in patients with IBD."
The full text of the announcement from Vedanta Biosciences is as
follows:
Vedanta Biosciences Announces Additional Pharmacokinetics Data
from Phase 1 Study of VE202 for Inflammatory Bowel Disease to be
Presented at United European Gastroenterology Week 2020
Phase 1 development partner Janssen to present data showing
VE202 microbiome-derived bacterial strains rapidly, abundantly and
durably colonise the gut of healthy volunteers
CAMBRIDGE, Mass., October 12, 2020 - 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 colonisation
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, PhD, 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 programme 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 colonised the gut abundantly and above
background strains detected by qPCR. Colonisation was most
effective with vancomycin pre-treatment followed by multiple doses
of the consortium. In multiple-day dosing cohorts, vancomycin
pre-treatment 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 characterise 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 standardised drug product in
powdered form and bypasses the need to rely on direct sourcing of
faecal 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.
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated
to discovering, developing and commercialising highly
differentiated medicines for devastating diseases, including
intractable cancers, lymphatic and gastrointestinal diseases,
central nervous system disorders and inflammatory and immunological
diseases, 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 24 products and product candidates, including two
that have received US Food and Drug Administration (FDA) clearance
and European marketing authorisation. All of the underlying
programmes and platforms that resulted in this pipeline of product
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.
Forward Looking Statement
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, the Company's expectations regarding VE202's potential
therapeutic benefits or future success 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 US media
Allison Mead Talbot Ben Atwell, Rob Winder Stephanie Simon
+1 617 651 3156 +44 (0) 20 3727 1000 +1 617 581 9333
amt@puretechhealth.com ben.atwell@FTIconsulting.com stephanie@tenbridgecommunications.com
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