TIDMPRTC
PureTech Health PLC
30 September 2020
30 September 2020
PureTech Health plc
PureTech Founded Entity Vedanta Biosciences Awarded Up to $76.9
Million Including $7.4 Million Upfront from BARDA to Advance the
Development of VE303
Award is first-ever by BARDA directed to advance development of
a microbiome drug
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 it has been awarded funding of
$7.4 million, with the potential for up to an additional $69.5
million, from the Biomedical Advanced Research and Development
Authority (BARDA) to advance clinical development of VE303 for
high-risk Clostridioides difficile infection (CDI).
Vedanta Biosciences is the first-ever recipient of a BARDA award
in the microbiome field. The funding will support completion of an
ongoing Phase 2 trial and further clinical development of VE303, a
rationally-defined, orally-administered live biotherapeutic product
(LBP) consisting of eight well-characterised commensal bacterial
strains designed to effect robust and durable therapeutic changes
in a patient's gut microbiota. A previous Phase 1a/1b study
demonstrated rapid, durable, dose-dependent colonisation and
accelerated restoration of gut microbiota in healthy volunteers who
were pretreated with antibiotics.
The full text of the announcement from Vedanta Biosciences is as
follows:
Vedanta Biosciences Awarded Up to $76.9 Million Including $7.4
Million Upfront from BARDA to Advance the Development of VE303, a
Defined Bacterial Consortium for Prevention of C. difficile
Infection in High-Risk Patients
Award is first-ever by BARDA directed to advance development of
a microbiome drug
CAMBRIDGE, Mass., September 30, 2020 - 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 been
awarded funding of $7.4 million, with the potential for up to an
additional $69.5 million, from the Biomedical Advanced Research and
Development Authority (BARDA) to advance clinical development of
VE303 for high-risk Clostridioides difficile infection (CDI).
The funding will support completion of an ongoing Phase 2 trial
and further clinical development of VE303, a rationally-defined,
orally-administered live biotherapeutic product (LBP) consisting of
eight well-characterised commensal bacterial strains designed to
effect robust and durable therapeutic changes in a patient's gut
microbiota. A previous Phase 1a/1b study demonstrated rapid,
durable, dose-dependent colonisation and accelerated restoration of
gut microbiota in healthy volunteers who were pretreated with
antibiotics.
The ongoing Phase 2 study is a multi-centre, randomised,
double-blind, placebo-controlled trial designed to evaluate the
safety and efficacy of two doses of VE303 compared to placebo in
patients with high-risk CDI. The study is enrolling patients with a
recent confirmed diagnosis of CDI who have completed a course of
antibiotics but remain at high risk for recurrence. The primary
endpoint is prevention of infection recurrence at eight weeks.
"We are honoured to be the first-ever recipient of a BARDA award
in the microbiome field and look forward to collaborating with the
US Government to advance the clinical development of VE303 and to
potentially fulfil its promise in public health and biodefense,"
said Bernat Olle, PhD, co-founder and chief executive officer of
Vedanta Biosciences. "CDI accounts for approximately 12,800 deaths
each year in the US alone and are the result of damage to the gut
microbiota caused by both necessary and unnecessary antibiotic use.
We believe restoration of the gut microbiota after antibiotic use
is a new paradigm in infection control that could improve patient
outcomes following a broad range of procedures that rely on
antibiotics, as well as a key underappreciated potential strategy
in antimicrobial stewardship."
BARDA, a division within the Office of the Assistant Secretary
of Preparedness in the US Department of Health and Human Services,
supports a diverse portfolio of emerging therapeutics and devices.
Programmes supported by BARDA have received a total of 55 FDA
approvals, licensures or clearances.
"The concept of rationally-designed live biotherapeutic products
has strong merit for treating infectious diseases such as C.
difficile," said Gary Disbrow, PhD, BARDA Acting Director. "If
successful, VE303 could prevent high-risk C. difficile and reduce
our dependency on antibiotics, which would be a major win for
public health. We're enthusiastic about the opportunity to address
both of these issues and proud to support clinical development of
VE303."
The grant from BARDA includes $7.4 million of guaranteed initial
funding and up to an additional $69.5 million, subject to BARDA
exercising multiple options under the award.
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
donor faecal material of inconsistent composition. VE303 consists
of a defined consortium of live bacteria designed to restore
colonisation resistance against gut pathogens, including C.
difficile. Vedanta Biosciences received a $5.4 million research
grant from CARB-X in 2017 and a grant from BARDA in 2020 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 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 BARDA
The Biomedical Advanced Research and Development Authority
(BARDA), an agency within the HHS Office of the Assistant Secretary
for Preparedness and Response (ASPR), provides a comprehensive,
integrated, portfolio approach to the advanced research and
development, innovation, acquisition, and manufacturing
infrastructure for vaccines, drugs, therapeutics, diagnostic tools,
and non-pharmaceutical products for public health emergency
threats. These threats include chemical, biological, radiological,
and nuclear threats, pandemic influenza and emerging infectious
diseases. For more information, visit
https://www.phe.gov/about/barda/ . Members of the media can contact
ASPRMedia@hhs.gov.
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 the use of BARDA funding
to continue development of VE303 and the potential for additional
funding 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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END
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