TIDMPRTC
RNS Number : 1130V
PureTech Health PLC
05 August 2015
5 August 2015
PureTech Health plc
Karuna Receives Wellcome Trust Award to Advance Innovative
Clinical Stage Product Candidate for the Treatment of
Schizophrenia
Karuna Pharmaceuticals, Inc. ("Karuna", a PureTech Health plc
(PureTech, PRTC.L) operating company) announces receipt of a
Translation Fund Award from the Wellcome Trust of up to $3.84
million. Additionally, PureTech is investing a further $1.5 million
in Karuna. The funding will be applied to further develop Karuna's
lead program, KarXT, a potentially innovative therapy for the
treatment of schizophrenia.
Daphne Zohar, Chief Executive Officer of PureTech, said: "We are
honored by the support of the Wellcome Trust and the recognition of
the potential of Karuna's KarXT program as a potentially ground
breaking new approach for treating schizophrenia. This award,
recognizing the important work of Karuna, provides further external
validation of our approach and the potential to have an impact on
patient's lives."
Karuna Receives Wellcome Trust Award to Advance Innovative
Clinical Stage Product Candidate for the Treatment of
Schizophrenia
Boston, August 5, 2015 - Karuna Pharmaceuticals, Inc.
("Karuna"), a PureTech (PureTech Health plc PRTC.L) company
developing a novel product candidate for the treatment of
schizophrenia, announced today that it has received a Translation
Fund Award from the Wellcome Trust comprising an unsecured
convertible loan to Karuna of up to $3.84 million. The funding,
along with other capital, will be applied to further develop
Karuna's lead program KarXT, a potentially innovative therapy for
the treatment of schizophrenia.
Schizophrenia is a severe and chronic mental health disorder
that affects more than 21 million people worldwide. The disease is
characterized by profound disruptions in thinking, affecting
language, perception, and the sense of self, that typically
includes psychotic episodes. Antipsychotics are the mainstay
therapy for the treatment of schizophrenia. However, significant
unmet need remains due to the limited efficacy and potential
serious side effects associated with current antipsychotic
medications.
"Few safe and effective new mechanisms for therapy of
schizophrenia have emerged over the last half- century, and we
believe that Karuna's novel approach has the potential to change
the treatment paradigm in the field," said Dr. Ben Shapiro,
Non-Executive Director of Karuna and PureTech and formerly
Executive Vice President of Merck Research Laboratories. "We are
delighted that the Wellcome Trust is supporting the development of
this potentially important new therapy for schizophrenia, a disease
that has a devastating impact on the lives of patients and their
loved ones."
KarXT selectively targets the muscarinic system and is composed
of xanomeline, a novel clinical-stage muscarinic acetylcholine
receptor agonist (activator) and trospium chloride, an FDA-approved
and well-established muscarinic receptor antagonist (blocker). The
muscarinic system consists of five receptor subtypes that both bind
acetylcholine and are widely distributed through the human body and
have been linked to distinct physiological functions, including
cognition.
Xanomeline has demonstrated efficacy in reducing psychosis and
improving cognition in placebo-controlled human trials in both
Alzheimer's disease and schizophrenia. In a double-blind,
placebo-controlled monotherapy trial in schizophrenia patients, a
significant 24-point reduction over placebo was observed in the
Positive and Negative Symptom Scale.
While xanomeline alone has displayed strong efficacy, it has
side effects associated with binding receptors outside the central
nervous system, limiting its therapeutic utility. Karuna believes
that the addition of trospium chloride may reduce the side effects
typically seen with xanomeline alone. As a muscarinic antagonist
(blocker), trospium chloride could potentially inhibit xanomeline's
binding to peripheral receptors, and therefore improve xanomeline's
safety profile. At the same time, since it has been shown that
trospium chloride does not enter the central nervous system, we
expect that it would not inhibit xanomeline's binding to muscarinic
receptors in the brain. Karuna has a worldwide exclusive license
for xanomeline, as detailed in PureTech's IPO prospectus published
on 19 June 2015, and has a patent portfolio more broadly covering
selective muscarinic targeting enabled by the KarXT approach.
Karuna plans to conduct a safety proof of concept study in 2016
to demonstrate that trospium chloride can improve xanomeline's
tolerability profile, followed by a Phase II efficacy study of
KarXT.
"The muscarinic system has shown enormous promise as a
therapeutic target for the treatment of schizophrenia, but
development efforts have been limited by tolerability concerns,"
said Alan Brier, M.D., Karuna's Chief Clinical Advisor and the
former Chief Medical Officer at Eli Lilly. "The KarXT program has
the potential to fulfill the long-held promise of therapeutics
targeting muscarinic receptors."
PureTech, as part of its continued commitment to Karuna, is also
investing an additional $1.5 million to support the development of
the KarXT program through its next milestone. PureTech has
committed up to an additional $17.5M to Karuna, pending the results
of the next clinical trial which is fully funded.
About Wellcome Trust
The Wellcome Trust is a global charitable foundation dedicated
to improving health. It provides more than GBP700 million a year to
support bright minds in science, the humanities and the social
sciences, as well as education, public engagement and the
application of research to medicine. Its GBP18 billion investment
portfolio gives us the independence to support such transformative
work as the sequencing and understanding of the human genome,
research that established front-line drugs for malaria, and
Wellcome Collection, its free venue for the incurably curious that
explores medicine, life and art. www.wellcome.ac.uk
About Wellcome Trust Translation Fund Awards
The aim of Wellcome Trust Translation Awards is to develop
innovative and ground breaking new technologies in the biomedical
area. Projects must have already demonstrated proof of principle,
supported by experimental data. Applications should bridge the
funding gap in commercialization of new technologies in the
biomedical area and must plan to take the product, technology or
intervention to a stage at which it is sufficiently developed to be
attractive to another party.
About Karuna
Karuna is a clinical-stage drug development company pursuing
innovative therapies for the treatment of schizophrenia. Karuna's
lead program, KarXT, is a product candidate consisting of
xanomeline, a novel clinical-stage muscarinic acetylcholine
receptor agonist (activator) that has demonstrated efficacy in
reducing psychosis and improving cognition in placebo-controlled
human trials, and trospium chloride, an FDA-approved and
well-established muscarinic receptor antagonist (blocker) that
studies have shown does not enter the central nervous system. For
more information, visit www.karunapharma.com.
CONTACT
Julie DiCarlo
617-226-4819
jd@puretechhealth.com
About PureTech
PureTech (PureTech Health plc, PRTC.L) is a science-driven
healthcare company, seeking to solve some of today's toughest
health challenges through disruptive approaches. Based in Boston,
Massachusetts, PureTech has a pipeline of 12 operating companies,
seven of which are "growth stage" with external validation
including strategic partnerships, outside funding, proof-of-concept
or peer review in prestigious scientific journals. PureTech is
problem-focused and solution-agnostic, looking beyond traditional
disciplines and approaching healthcare problems from different
perspectives. Focusing on areas of significant unmet medical need,
PureTech evaluates more than 650 ideas per year, prioritizing,
selecting and testing what it believes to be the most
scientifically and commercially promising concepts to advance.
PureTech's leading team and board, along with an advisory network
of more than 50 experts across multiple disciplines, gives PureTech
access to potentially groundbreaking science and technological
innovations. For more information, visit www.puretechhealth.com and
connect with us on Twitter.
PureTech has holdings of 81.5% in Karuna on a diluted basis, and
is entitled to a royalty on net sales of KarXT. This calculation of
PureTech's holding includes issued and outstanding shares as well
as options to purchase shares, but excludes unallocated shares
authorised to be issued pursuant to equity incentive plans and any
shares issuable upon conversion of outstanding convertible
promissory notes.
PureTech 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 company's regulatory filings. 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, regulatory requirement, the Listing Rules and the
Disclosure and Transparency Rules, 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.
Enquiries:
PureTech
Daphne Zohar, Chief Executive Officer
Stephen Muniz, Executive Vice President, Legal,
Finance and Operations
Julie DiCarlo, Senior Vice President, Communications
and Investor Relations +1 617 456 0032
FTI Consulting (Communications adviser to PureTech)
Ben Atwell +44 (0) 20 3727
Matthew Cole 1000
This information is provided by RNS
The company news service from the London Stock Exchange
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