TIDMPRTC
PureTech Health PLC
21 May 2019
21 May 2019
PureTech Health plc
PureTech Health Affiliate Vedanta Biosciences Announces Expanded
Data from Successful Phase 1a/1b Study of VE303 at Digestive
Disease Week
Expanded data on rapid, durable, and dose-dependent colonisation
of VE303 strains further support optimal dosing regimen and
pharmacodynamics of gut microbiota restoration
Phase 2 study of VE303 in recurrent Clostridium difficile
infection is ongoing
PureTech Health plc (LSE:PRTC) ("PureTech Health"), an advanced
biopharmaceutical company developing novel medicines for
dysfunctions of the Brain-Immune-Gut (BIG) axis, is pleased to note
that its affiliate Vedanta Biosciences announced the presentation
of expanded data from its Phase 1a/1b study of VE303, the Company's
lead, orally-administered live biotherapeutic product (LBP)
candidate for recurrent Clostridium difficile infection (rCDI). In
a milestone for the microbiome field, VE303 data demonstrated that
Vedanta's product candidate, composed of a defined bacterial
consortium, administered as a standardised lyophilized powder in
capsule form, induced rapid, durable and dose-dependent
colonisation of VE303 strains. The data were presented at Digestive
Disease Week 2019, the world's largest gathering of physicians,
researchers, and industry in the fields of gastroenterology,
hepatology, endoscopy, and gastrointestinal surgery, held in San
Diego, California.
VE303 is currently being evaluated in a Phase 2 study designed
to evaluate the safety and efficacy of two different dosages in
patients with rCDI. The data from the presentation support the
dosing regimen selected for this study and further validate the
Company's rationally-defined consortia approach.
The full text announcement from Vedanta Biosciences is as
follows:
Vedanta Biosciences Presents Positive Expanded Data from Phase
1a/1b Study of VE303 at Digestive Disease Week
Expanded data on rapid, durable, and dose-dependent colonisation
of VE303 strains further support optimal dosing regimen and
pharmacodynamics of gut microbiota restoration
Phase 2 study of VE303 in recurrent Clostridium difficile
infection is ongoing
CAMBRIDGE, Mass., May 20, 2019 - Vedanta Biosciences, a
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 the presentation
of expanded, long-term positive data from its Phase 1a/1b study of
VE303, the Company's lead, orally-administered live biotherapeutic
product (LBP) candidate for recurrent Clostridium difficile
infection (rCDI). The data were presented at Digestive Disease Week
2019, held in San Diego, California, and supports the dosing
employed in the ongoing Phase 2 study of VE303 and further
illuminate interactions between VE303 and gut microbiota.
The expanded data build on the preliminary results of the Phase
1a/1b study previously disclosed by the Company, which found that
all doses of VE303 were safe and well-tolerated and that treatment
with VE303 resulted in rapid, durable, and dose-dependent
colonisation of VE303 strains across a heterogenous group of 23
adults. The study also found that VE303 treatment accelerated the
restoration of gut microbiota after a course of antibiotics.
"This study served as an important validation for our approach
of developing rationally-defined consortia and our ability to
quantify their pharmacology," said Bernat Olle, Ph.D., chief
executive officer of Vedanta Biosciences. "These expanded data
underscore the benign safety profile of VE303 and further
demonstrate the pharmacokinetics of colonisation and its
relationship to dose exposure and gut microbiota restoration after
treatment with antibiotics."
In late 2018, Vedanta announced the initiation of a Phase 2,
multi-centre, randomised, double-blind, placebo-controlled study
("CONSORTIUM") designed to evaluate the safety and efficacy of two
doses of VE303 compared to placebo in patients with rCDI. The study
is expected to enrol up to 146 patients with a recent diagnosis of
rCDI, confirmed using a Clostridium difficile toxin assay, and who
have completed a course of antibiotics but remain at risk for
recurrence. The primary endpoint will be prevention of infection
recurrence at eight weeks.
About VE303
VE303 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. VE303 is
designed to restore colonisation resistance against gut pathogens,
including C. difficile, after treatment with antibiotics. In 2017,
Vedanta Biosciences received a $5.4 million research grant from
CARB-X (Combating Antibiotic Resistant Bacteria Biopharmaceutical
Accelerator) to support clinical studies of VE303. VE303 was
granted Orphan Drug Designation in 2017 by the United States Food
and Drug Administration (FDA) for the prevention of recurrent C.
difficile infection (rCDI) and is currently being evaluated in a
Phase 2 clinical study for the treatment of rCDI.
About Vedanta Biosciences
Vedanta Biosciences is a clinical-stage microbiome leader
developing a new category of therapies for immune-mediated diseases
based on rationally-defined consortia of human microbiome-derived
bacteria. Vedanta's proprietary capabilities include what is
believed to be the largest collection of human-gut associated
bacteria, assays and bioinformatics techniques for consortia design
and optimisation, vast datasets from human interventional studies
and facilities for cGMP-compliant manufacturing of
rationally-defined bacterial consortia in powder form.
Vedanta Biosciences' pioneering work, in collaboration with its
scientific co-founders, has led to the identification of human
commensal bacteria that induce a range of immune responses -
including induction of regulatory T cells, CD8+ T cells, and Th17
cells, among others. These advances have been published in leading
peer-reviewed journals, including Science (multiple), Nature (2013,
2019), Cell, and Nature Immunology. Vedanta Biosciences has
harnessed these biological insights and its capabilities to
generate a pipeline of investigational live biotherapeutic products
(LBPs) in infectious disease, autoimmune disease, allergy, and
immuno-oncology. This pipeline includes 2 clinical-stage product
candidates currently being evaluated for the treatment of recurrent
C. difficile infection and inflammatory bowel disease (in
collaboration with Janssen Biotech, Inc.) as well as two additional
product candidates entering the clinic in 2019 in food allergy and
in patients with advanced or metastatic cancers (in combination
with Bristol-Myers Squibb's checkpoint inhibitor OPDIVO(R)).
Vedanta's IP portfolio contains 20 US patents and numerous
foreign issuances with coverage extending to 2037. Earlier this
year, the European Patent Office upheld Vedanta's foundational
Honda Patent, which is now issued in major commercial markets,
including the United States, Europe, and Japan. Vedanta Biosciences
was founded by PureTech Health (LSE.PRTC). Its scientific
co-founders are world-renowned experts in immunology and
microbiology who have pioneered the fields of innate immunity, Th17
and regulatory T cell biology.
About PureTech Health
PureTech Health (LSE: PRTC) is an advanced biopharmaceutical
company developing BIG medicines for dysfunctions of the
Brain-Immune-Gut axis. The Company has gained deep insights into
the connection between these systems and the resulting role in
diseases that have proven resistant to established therapeutic
approaches. By harnessing this emerging field of human biology,
PureTech Health is developing new categories of medicines with the
potential to have great impact on people with serious diseases.
PureTech Health is advancing a rich pipeline of innovative
therapies with an unbiased, non-binary, and capital efficient
R&D model across its affiliates and its internal labs.
PureTech's affiliates include seven clinical-stage platforms,
including one product that has been cleared by the US Food and Drug
Administration (FDA) and a second product candidate that has been
filed with the FDA for review, and several other novel preclinical
programmes. The PureTech Health pipeline includes ground-breaking
platforms and therapeutic candidates that were developed in
collaboration with some of the world's leading experts.
PureTech's internal research and development is centred on
tissue-selective immunomodulation for the treatment of oncology,
autoimmune, and CNS-related disorders, with a near-term focus on
targeting newly-discovered, foundational immunosuppressive
mechanisms in oncology and novel approaches that harness the
lymphatic infrastructure.
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, 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 Tom Donovan
+1 617 651 3156 +44 (0) 20 3727 1000 +1 857 559 3397
amt@puretechhealth.com ben.atwell@FTIconsulting.com tom@tenbridgecommunications.com
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END
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