TIDMPRTC
PureTech Health PLC
04 October 2018
4 October 2018
PureTech Health plc
PureTech's Vedanta Biosciences Announces Successful Phase 1a/1b
Demonstrating Safety, Tolerability, and Proof of Mechanism for Lead
Product Candidate, VE303
A Phase 2 study in recurrent C. difficile infection is expected
to begin in the fourth quarter of 2018
Three other programmes in immuno-oncology, allergy, and
inflammatory bowel disease, are expected to enter the clinic within
the next nine months
PureTech Health plc (LSE: PRTC) ("PureTech Health"), an advanced
biopharmaceutical company developing novel medicines for
dysfunctions of the Brain-Immune-Gut (BIG) Axis, today announced
that Vedanta Biosciences reported preliminary results from the
Phase 1a/1b clinical study in healthy volunteers for its lead,
orally-administered live biotherapeutic product (LBP) candidate for
recurrent Clostridium difficile infection (rCDI), VE303. A Phase 2
study in this therapeutic indication is expected to begin before
the end of the year.
The results showed that VE303 was safe and well-tolerated at all
doses. The study also demonstrated rapid, abundant, and durable
intestinal colonisation of the VE303 strains, demonstrating proof
of mechanism for this product candidate consisting of a defined
consortium of human microbiome-derived bacteria.
Joseph Bolen, PhD, Chief Scientific Officer at PureTech Health,
said: "We know that a community of microbes - versus a single
strain - is required to re-establish a healthy microbiome since
these bacteria work in concert with each other to promote the
growth of beneficial bacteria and reduce the levels of pathogenic
bacteria. This is the foundation for Vedanta's consortia-based
approach, which is now supported by these results and the fact that
we were able to track the robust and durable colonisation of each
bacterial strain comprising VE303. This rational development of
proprietary microbiome-based drugs is the hallmark of Vedanta's
pipeline, which is expected to include three additional
clinical-stage product candidates in IBD (in partnership with
Janssen), food allergy, and cancer immunotherapy within the next
nine months."
The full text announcement from Vedanta Biosciences is as
follows:
Vedanta Biosciences Announces Successful Phase 1a/1b Data
Demonstrating Safety, Tolerability, and Proof of Mechanism for
Lead, Rationally Defined Bacterial Consortium Product Candidate,
VE303
All doses were safe and well-tolerated
VE303 treatment resulted in rapid, durable, dose-dependent
colonisation and accelerated gut microbiota restoration after
antibiotics
A Phase 2 study in recurrent C. difficile infection is expected
to begin in the fourth quarter of 2018
Three other programmes in immuno-oncology, allergy, and
inflammatory bowel disease are expected to enter the clinic within
the next nine months
Cambridge, Massachusetts, October 4, 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 preliminary
results from the Phase 1a/1b clinical study in healthy volunteers
for its lead, orally-administered live biotherapeutic product (LBP)
candidate for recurrent Clostridium difficile infection (rCDI),
VE303. With these Phase 1 data to support dosage selection, Vedanta
Biosciences expects to begin a Phase 2 study before the end of the
year to evaluate the safety and efficacy of VE303 in patients with
rCDI. Additional exploration of VE303 in healthy volunteers to
inform dose selection in other indications is ongoing.
This study was designed to evaluate safety and tolerability of a
range of doses of VE303 in healthy adult volunteers. The study also
evaluated pharmacokinetics of intestinal colonisation by the VE303
strains and pharmacodynamics of recovery of the gut microbiota
after administration of antibiotics followed by a course of
VE303.
Summary of Key Findings:
1. Single and multiple doses of VE303, after vancomycin
administration, ranging up to 1.1 x 10(11) total colony forming
units (CFU), were safe and well-tolerated. Adverse events related
to VE303 administration occurred in less than one third of study
volunteers and all were Grade 1.
2. Abundant colonisation of VE303 strains that lasted for at
least 12 weeks was detected at all doses.
3. Repeated dosing led to increased robustness of strain
colonisation (i.e., a majority of VE303 strains colonised in a
majority of volunteers).
4. VE303 accelerated microbiota recovery after vancomycin
administration in a dose-dependent manner compared to recovery
without VE303, demonstrating proof of mechanism.
"We believe these Phase 1a/1b results represent a significant
milestone for the microbiome field. VE303's favourable safety
profile, and - most notably - its ability to rapidly, abundantly,
and durably colonise a heterogenous population of healthy adults
provides a scientific rationale for use of defined bacterial
consortium drugs and moves the field beyond the use of undefined
faecal transplants," said Bernat Olle, PhD, Co-founder and Chief
Executive Officer of Vedanta Biosciences. "The robust relationship
between dose exposure and response we have observed informs a
rational dose selection for VE303 Phase 2 studies and supports its
potential as a first-in-class therapy for prevention of recurrent
Clostridium difficile infection."
Unlike single strain 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. Unlike 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. VE303 is the first
product candidate, to the Company's knowledge, consisting of a
rationally-defined bacterial consortium in lyophilised powder form
to be clinically investigated.
About the Study
The Phase 1a/1b study was an open-label, single-centre, single-
and multiple- dose-escalation study assessing the safety and
tolerability of VE303 in healthy adult volunteers. Twenty-three
volunteers were enrolled to receive VE303 after vancomycin
administration, three cohorts received single ascending doses of
VE303 that ranged from 1.6x10(9) to 8x10(9) CFU, and two cohorts
received total cumulative doses of VE303 ranging from 4x10(10) to
1.1x10(11) CFU over five or 14 days. The study also included a
control cohort of five volunteers who received only vancomycin.
Metagenomic sequencing of faecal samples collected longitudinally
over 12 weeks was used to assess VE303's pharmacokinetics (speed,
durability, abundance, and robustness of bacterial strain
colonisation) and the pharmacodynamics of VE303's impact on
post-antibiotic gut microbiota restoration.
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 LBPs. 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 infectious disease, autoimmune
disease, allergy, 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 Dr Ruslan Medzhitov
(Yale and Howard Hughes Medical Institute (HHMI)), Dr Brett Finlay
(University of British Columbia and HHMI), Dr Kenya Honda (inventor
of Vedanta Biosciences' lead product candidate; Keio University and
RIKEN), Dr Dan Littman (New York University and HHMI), Dr Alexander
Rudensky (Sloan Kettering and HHMI), and Dr Jeremiah Faith (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
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END
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