TIDMPRTC
PureTech Health PLC
17 December 2018
17 December 2018
PureTech Health plc
PureTech's Vedanta Biosciences Announces Initiation of a Phase 2
Study for Lead Product Candidate, VE303
First drug consisting of a rationally-defined bacterial
consortium to advance to Phase 2 study
Previously announced Phase 1a/1b study demonstrated rapid,
durable, dose-dependent colonisation and accelerated gut microbiota
restoration after antibiotics
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 Vedanta Biosciences today announced the initiation of a Phase
2 study of VE303, the Company's lead, orally-administered, live
biotherapeutic product (LBP) candidate for recurrent Clostridium
difficile infection (rCDI). Vedanta Biosciences' pipeline comprises
two clinical-stage programmes, including the recently announced
Phase 1 study of VE202 with Janssen Biotech, Inc. for inflammatory
bowel disease (IBD), and the Company expects to initiate two
additional studies in 2019.
Bharatt Chowrira, JD, PhD, President and Chief of Business and
Strategy at PureTech Health, said: "We are pleased with the
progress Vedanta Biosciences has made across its pipeline of
microbiome-derived live biotherapeutic product candidates, and we
look forward to the initiation of two additional clinical trials in
the coming months."
The full text announcement from Vedanta Biosciences is as
follows:
Vedanta Biosciences Initiates Phase 2 Study for Lead
Rationally-Defined Bacterial Consortium Product Candidate,
VE303
First drug consisting of a rationally-defined bacterial
consortium to advance to Phase 2 study
Previously announced Phase 1a/1b study demonstrated rapid,
durable, dose-dependent colonisation and accelerated gut microbiota
restoration after antibiotics
Cambridge, Mass., Dec. 17, 2018 - 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 it has initiated
a Phase 2 study of its lead, orally-administered live
biotherapeutic product (LBP) candidate, VE303, for recurrent
Clostridium difficile infection (rCDI). Vedanta Biosciences'
pipeline of microbiome-derived product candidates also includes the
recently announced Phase 1 study of VE202 with Janssen Biotech,
Inc. for inflammatory bowel disease (IBD), and the company expects
to initiate a Phase 1/2 study of VE416 in food allergy in Q1 2019
in addition to a Phase 1/2 study of VE800 and Opdivo (nivolumab) in
advanced or metastatic cancers in mid-2019.
The Phase 2, multi-centre, randomised, double-blind,
placebo-controlled CONSORTIUM study is designed to evaluate the
safety and efficacy of two doses of VE303 compared to placebo in
patients with rCDI. The study is expected to enroll 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.
"The results of the VE303 Phase 1a/1b are very promising, and I
look forward to the continued progression of this - and Vedanta's
other product candidates - through the clinic," said Ciaran P
Kelly, MD, Professor of Medicine, Harvard Medical School.
"Vedanta's approach yields product candidates with a defined and
uniform composition, potentially mitigating the safety and
variability challenges associated with approaches based on faecal
transplants or faecal fractions."
Dose selection for this study was based on the results of a
recently concluded Phase 1a/1b study of VE303 in healthy
volunteers. That study 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. The
Phase 1 study also found that VE303 treatment accelerated the
restoration of gut microbiota after a course of antibiotics.
"This is the first Phase 2 study, to our knowledge, of a
rationally-defined bacterial consortium candidate in any
indication, so it represents a major milestone for Vedanta
Biosciences and the field," said Bernat Olle, PhD, Co-founder and
Chief Executive Officer of Vedanta Biosciences. "Our Phase 1a/1b
study helped de-risk key questions for our modality, in particular
whether robust, durable colonisation - superior to what has been
reported for probiotics in the past - can be obtained with a
defined consortium and whether the right consortium can rapidly
restore the gut microbiota after antibiotics."
Unlike single strain or microbiome-derived metabolite approaches
to microbiome modulation, Vedanta Biosciences is developing
consortia of bacterial strains designed to effect robust and
durable therapeutic changes in a patient's gut microbiota. In
contrast to faecal transplants or administration of faecal
fractions, Vedanta Biosciences' consortia are defined compositions
of bacteria manufactured from pure, clonal cell banks, bypassing
the need to rely on direct sourcing of faecal donor material of
inconsistent composition.
About VE303
VE303 is an orally-administered investigational live
biotherapeutic product (LBP). It is produced 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 consists
of a defined consortium of live bacteria designed to restore
colonisation resistance against gut pathogens, including C.
difficile. 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).
About Vedanta Biosciences
Vedanta Biosciences is a clinical-stage company developing a new
category of therapies for immune-mediated diseases based on
rationally-defined consortia of human microbiome-derived bacteria.
Vedanta Biosciences is a leader in the microbiome field with
capabilities and deep expertise to discover, develop, and
manufacture live bacteria drugs. These include what is believed to
be the largest collection of human microbiome-associated bacterial
strains, a suite of proprietary assays to select pharmacologically
potent strains, vast proprietary 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
(multiple), Cell, and Nature Immunology. Vedanta Biosciences has
harnessed these biological insights and its capabilities to
generate a pipeline of programmes in autoimmune disease, allergy,
infectious disease, and immuno-oncology.
Vedanta Biosciences was founded by PureTech Health (PRTC.L). 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, and include Ruslan Medzhitov, PhD,
(Yale and Howard Hughes Medical Institute (HHMI)), Brett Finlay,
PhD, (University of British Columbia and HHMI), Kenya Honda, PhD,
(inventor of Vedanta Biosciences' lead product candidate; Keio
University and RIKEN), Dan Littman, PhD, (New York University and
HHMI), Alexander Rudensky, PhD, (Sloan Kettering and HHMI), and
Jeremiah Faith, PhD, (Mount Sinai School of Medicine).
About PureTech Health
PureTech Health (LSE: PRTC) is an advanced biopharmaceutical
company developing novel medicines for dysfunctions of the
Brain-Immune-Gut (BIG) Axis. The Company has developed deep
insights into the connection between the individual components of
these systems and the resulting role in many chronic diseases,
which 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 across two divisions: the Affiliates division and the
Internal division. Its Affiliates division includes two product
candidates that have been filed with the US Food and Drug
Administration (FDA) for review and several other novel clinical
and pre-clinical programmes. These affiliates are developing
ground-breaking platforms and therapeutic candidates in
collaboration with some of the world's leading experts.
PureTech's Internal division is advancing a pipeline fuelled by
recent discoveries in lymphatics and immune cell trafficking to
modulate disease in a tissue-specific manner. These programmes
leverage the transport and biodistribution of various immune system
components for the targeted treatment of diseases with major unmet
needs, including cancers, autoimmune diseases, and neuroimmune
disorders.
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
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
NRAEAAASFDNPFAF
(END) Dow Jones Newswires
December 17, 2018 02:01 ET (07:01 GMT)
Puretech Health (LSE:PRTC)
Historical Stock Chart
From Apr 2024 to May 2024
Puretech Health (LSE:PRTC)
Historical Stock Chart
From May 2023 to May 2024