TIDMPRTC
PureTech Health PLC
07 December 2017
7 December 2017
PureTech Health plc
PureTech's Microbiome Programme Advances into a Phase 1a/1b
Clinical Trial
VE303 is first known rationally-defined bacterial consortium in
powder form to enter the clinic and has received Orphan Drug
Designation from the US FDA for C. difficile indication
PureTech Health plc (LSE: PRTC), an advanced, clinical-stage
biopharmaceutical company, is pleased to note that Vedanta
Biosciences, an affiliate of PureTech Health, today announced the
initiation of a Phase 1a/1b clinical trial of VE303, the Company's
lead, orally-administered, human microbiome-derived product
candidate. VE303 is the first known investigational drug consisting
of rationally-defined bacterial consortium in powder form to enter
the clinic. It is comprised of a group of bacteria selected based
on their ability to shield against life-threatening infections,
including recurrent C. difficile infection (rCDI). The Phase 1a/1b
clinical trial is expected to be completed in the first half of
2018, and, pending those results, Vedanta plans to initiate a Phase
2 trial in 2018 for the treatment of rCDI.
Joe Bolen, PhD, Chief Scientific Officer of PureTech Health
said: "We believe VE303 is the only rationally-defined bacterial
consortium in powder form to advance into the clinic in any
indication. This is a key milestone for the microbiome field as
this new category of medicine requires a reproducible, predictable,
and scalable composition to realise its full potential."
Vedanta also announced today that the United States Food and
Drug Administration (FDA) have granted VE303 Orphan Drug
Designation. Orphan Drug Designation is a status given to drugs and
biologics that are intended for the safe and effective treatment,
diagnosis or prevention of rare diseases or disorders that affect
fewer than 200,000 people in the US. rCDI is one of the most urgent
bacterial threats and accounts for 15,000 deaths each year in the
US alone. Existing interventions include antibiotics, which have an
undesirable side effect of damaging the gut microbiome and leaving
patients vulnerable to re-infection and building resistance to
antibiotics. Microbiome-based therapies offer an alternative to
antibiotics that could address both of these problems at once, and
in November of this year, Vedanta Biosciences was selected for a
$5.4 million research grant from CARB-X (Combating Antibiotic
Resistant Bacteria Biopharmaceutical Accelerator) to support
clinical testing of VE303.
The full text of the announcement from Vedanta Biosciences is as
follows:
Vedanta Biosciences Announces Initiation of Phase 1a/1b Trial
for New Drug Class of Rationally-Defined Bacterial Consortia
Derived from the Human Microbiome
VE303 is first known rationally-defined bacterial consortium in
powder form to enter the clinic and has received Orphan Drug
Designation from the US FDA for C. difficile indication
CAMBRIDGE, Massachusetts, December 7, 2017 - Vedanta
Biosciences, an affiliate of PureTech Health (LSE: PRTC) developing
a new category of therapies for immune-mediated and infectious
diseases based on rationally defined consortium of human
microbiome-derived bacteria, today announced the initiation of a
Phase 1a/1b, first-in-human, clinical trial of VE303, the Company's
lead, orally-administered microbiome therapeutic product candidate
for recurrent Clostridium difficile infection (rCDI). VE303 is the
first known investigational drug consisting of a rationally-defined
bacterial consortium in powder form to enter the clinic. Vedanta
also today announced that VE303 has been granted Orphan Drug
Designation by the United States Food and Drug Administration
(FDA).
"The initiation of this study marks an important milestone for
both Vedanta Biosciences and the microbiome field, as we've been
able to advance a new class of drugs to the clinic," said Bernat
Olle, PhD, Chief Executive Officer of Vedanta Biosciences.
"First-generation approaches in the microbiome field have relied on
uncharacterised faecal material or spore fractions of faecal
material, which are inherently inconsistent procedures. Products
with a rationally-defined composition are the next logical step in
the evolution of the microbiome field. We believe VE303 is the
first rationally-defined bacterial consortium in powder form to
advance into the clinic in any indication, and we plan to rapidly
advance two additional programmes into clinical development in
2018."
VE303 is an orally-administered investigational microbiome
therapeutic consisting of live bacteria designed to restore
colonisation resistance against gut pathogens, including C.
difficile, following recurrence. The Phase 1a/1b, dose-escalating
study will assess the safety, tolerability, and colonisation of
VE303 in healthy volunteers, and will enrol approximately 30
subjects. The primary outcome of the study is the evaluation of the
safety and tolerability of VE303, and secondary outcomes include
the kinetics of intestinal colonisation by the bacteria in VE303.
The study is expected to be completed in the first half of 2018.
Pending the results of this study, Vedanta plans to initiate a
Phase 2 trial in rCDI in 2018.
VE303 has also been granted Orphan Drug Designation by the
United States Food and Drug Administration (FDA). Orphan Drug
Designation is a status given to drugs and biologics that are
intended for the safe and effective treatment, diagnosis or
prevention of rare diseases or disorders that affect fewer than
200,000 people in the US. The Centers for Disease Control and
Prevention (CDC) considers C. difficile infections one of the most
urgent bacterial threats. C. difficile infections account for
15,000 deaths each year in the US alone. Existing interventions for
C. difficile infections include antibiotics, which have the
undesirable side effect of damaging the gut microbiome, leaving
patients vulnerable to re-infection and building resistance to
antibiotics. Microbiome-based therapies offer an alternative to
antibiotics that could address both of these problems at once.
About VE303
VE303 is an orally-administered investigational microbiome
therapeutic. It is produced from pure, clonal cell banks, which
yield a standardised drug product in powder form and bypass the
need to rely on direct sourcing of faecal donor material of
inconsistent composition. It consists of a defined consortium of
live bacteria designed to restore colonisation resistance against
gut pathogens, including C. difficile. VE303 was generated using
Vedanta's proprietary discovery platform, which leverages what is
believed to be the largest collection of human
microbiome-associated bacterial strains, and is manufactured
in-house at Vedanta's state-of-the-art, cGMP-compliant
facilities.
In November 2017, the VE303 programme received a grant of up to
$5.4 million from CARB-X (Combating Antibiotic Resistant Bacteria
Biopharmaceutical Accelerator), a global public-private partnership
focused on funding the development of promising new antibacterial
products and rapid diagnostics. This was CARB-X's first award
announced for a microbiome project and also the first for a project
targeting C. difficile.
About Vedanta Biosciences
Vedanta Biosciences is pioneering development of a new category
of therapies for immune-mediated and infectious diseases based on
rationally designed consortia of bacteria derived from the human
microbiome. An affiliate of PureTech Health (PureTech Health plc,
PRTC.L), Vedanta's founding team includes a group of world-renowned
experts in immunology and microbiology. Vedanta Biosciences is a
leader in the microbiome field with capabilities and deep expertise
to discover, develop and manufacture drugs based on live bacterial
consortia. The Company's facilities include integrated
manufacturing operations providing cGMP-compliant manufacturing of
rationally-designed bacterial consortia in powder form. Leveraging
its proprietary technology platform and the expertise of its team
of scientific co-founders, Vedanta Biosciences has isolated and
maintains the largest collection of human microbiome-associated
bacterial strains and has characterised, in collaborations with
leading experts, how the immune system recognises and responds to
these microbes. This pioneering work 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 - as well as the characterisation of novel
molecular mechanisms of microbial-host communication. These
advances have been published in leading peer-reviewed journals
including Science (multiple), Nature (multiple), Cell and Nature
Immunology. Vedanta Biosciences has harnessed these biological
insights, its proprietary library of microbiome-derived bacterial
strains, as well as data from clinical translational
collaborations, to generate a pipeline of programmes addressing
infectious diseases, autoimmune diseases, inflammation and
immune-oncology indications.
Vedanta Biosciences' scientific co-founders have pioneered the
fields of innate immunity, Th17 and regulatory T cell biology, and
include Dr Ruslan Medzhitov (Professor of Immunobiology at Yale),
Dr Alexander Rudensky (tri-institutional Professor at the Memorial
Sloan-Kettering Institute, the Rockefeller University and Cornell
University), Dr Dan Littman (Professor of Molecular Immunology at
NYU), Dr Brett Finlay (Professor at the University of British
Columbia) and Dr Kenya Honda (Professor, Keio University School of
Medicine). Vedanta is backed by Seventure, Invesco Asset
Management, and Rock Springs Capital and has collaborations with
leading institutions including Janssen Biotech, Inc., NYU Langone
Health and its Perlmutter Cancer Center, Stanford University School
of Medicine, Leiden University Medical Center, University of Tokyo,
Keio University, RIKEN, and the University of South Alabama
Mitchell Cancer Institute.
About PureTech Health
PureTech Health (PureTech Health plc, PRTC.L) is an advanced,
clinical-stage biopharmaceutical company developing novel medicines
targeting serious diseases that result from dysfunctions in the
nervous, immune, and gastrointestinal systems (brain-immune-gut or
the "BIG" axis), which together represent the adaptive human
systems. PureTech Health is at the forefront of understanding and
addressing the biological processes and crosstalk associated with
the BIG axis. By harnessing this emerging field of human biology,
the Company is pioneering new categories of medicine with the
potential to have great impact on people with serious diseases.
PureTech Health is advancing a rich pipeline of innovative
therapies that includes two pivotal stage programmes, multiple
human proof-of-concept studies and a number of early clinical and
pre-clinical programmes. PureTech's rich research and development
pipeline has been advanced in collaboration with some of the
world's leading scientific experts, who along with PureTech's team
of biopharma pioneers, entrepreneurs and seasoned Board, identify,
invent, and clinically de-risk new medicines. With this experienced
team pursuing cutting edge science, PureTech Health is building the
biopharma company of the future focused on improving and extending
the lives of people with serious disease. 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
PureTech'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. 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 PureTech Health 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:
PureTech Health FTI Consulting
Allison Mead Talbot Ben Atwell, Rob
+1 617 651 3156 Winder
amt@puretechhealth.com +44 (0) 20 3727
1000
This information is provided by RNS
The company news service from the London Stock Exchange
END
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