TIDMPRTC
RNS Number : 7833R
PureTech Health PLC
19 June 2018
19 June 2018
PureTech Health plc
PureTech's Karuna Receives $8 Million Wellcome Trust Award to
Advance Phase 2 Product Candidate for the Treatment of
Schizophrenia
Karuna's proprietary approach leverages novel mechanism to treat
psychosis and cognition in mental health conditions
PureTech Health plc (LSE: PRTC) ("PureTech Health"), an
advanced, clinical-stage biopharmaceutical company, today announced
that its affiliate, Karuna, has received a Translational Fund Award
from the Wellcome Trust for approximately $8 million. The funding
will be used to advance Karuna's lead product candidate KarXT
through a Phase 2 study in people with schizophrenia.
Eric Elenko PhD, Chief of Research and Strategy at PureTech
Health, said: "This award from Wellcome acknowledges Karuna's
first-in-class approach to address CNS illnesses with tremendous
unmet need. We are well-positioned to continue to advance this
promising new treatment for schizophrenia, a debilitating disease
that affects over 20 million people, and we look forward to
potentially expanding across other CNS disorders."
Wellcome previously awarded Karuna $3.8 million to fund a Phase
1 tolerability proof-of-concept study with KarXT, which reported
successful results. Both awards have been structured in the form of
unsecured convertible loans.
The full text of the announcement from Karuna is as follows:
Karuna Receives $8 Million Wellcome Trust Award to Advance
First-in-Class Phase 2 Clinical Programme in Schizophrenia
Karuna's proprietary approach leverages novel mechanism to treat
psychosis and cognition in mental health conditions
BOSTON, June 19, 2018-Karuna Pharmaceuticals, an affiliate of
PureTech Health plc (LSE: PRTC), focused on targeting muscarinic
receptors for the treatment of disorders marked by psychosis and
cognitive symptoms, today announced that it has been awarded
approximately $8 million by the Wellcome Trust. The funding will be
used to further advance clinical development of Karuna's lead
programme, KarXT (Karuna-Xanomeline-Trospium), through a Phase 2
study in people with schizophrenia.
"Antipsychotics are the mainstay therapy for the treatment of
schizophrenia and have all relied on the same fundamental mechanism
of action for the past 60 years. Currently available treatments
have limited efficacy - primarily addressing only positive
symptoms, such as hallucinations and delusions - and are often
associated with serious, often irreversible, side effects, leaving
a significant need for new treatments for people living with this
devastating disease," said Andrew Miller, PhD, President and Chief
Executive Officer of Karuna. "With KarXT, we have an opportunity to
potentially improve positive, negative, and cognitive symptoms
based on prior compelling efficacy data with xanomeline, and
without the debilitating side effects of existing therapies. We are
delighted that Wellcome is continuing to back this important new
therapeutic approach."
Xanomeline previously demonstrated compelling efficacy in
double-blind placebo-controlled studies in schizophrenia and
Alzheimer's disease; at that time tolerability issues associated
with the activation of muscarinic receptors outside the brain
hindered xanomeline's further development. Karuna's KarXT is
designed to improve tolerability and unlock the potential of
muscarinic agonists by selectively targeting M1/M4 muscarinic
receptors in the brain while blocking their activation in tissues
outside the brain. KarXT has demonstrated a significant improvement
in tolerability compared to xanomeline in a double-blind,
placebo-controlled, healthy volunteer study, and Karuna is
currently completing a Phase 1 study using a proprietary
co-formulation of xanomeline and trospium. The Phase 2 acute
psychosis trial in people with schizophrenia is designed to
replicate and expand on the previous efficacy results with
xanomeline and is expected to begin in the third quarter of
2018.
Dr Lynsey Bilsland, from Wellcome's Innovations team said:
"Karuna's treatment candidate has the potential to have a
significant impact on patients affected by schizophrenia and other
psychotic disorders. Research in this important area has long been
under-resourced, and doctors and patients currently rely on
treatments which have existed for decades. Wellcome is committed to
supporting the innovation vital to developing global understanding
and treatment of mental illness and improving life for patients
affected."
Wellcome previously awarded Karuna $3.8 million to fund a Phase
1 tolerability proof-of-concept study with KarXT, which reported
successful results. Both awards have been structured in the form of
unsecured convertible loans.
About Schizophrenia
Schizophrenia affects more than 20 million people worldwide and
is characterised by profound disruptions to daily life. Symptoms
are grouped within three domains: positive, negative, and
cognitive. Positive symptoms are generally associated with
psychotic behaviours, including hallucinations and delusions.
Negative symptoms refer to disruptions in behaviour and emotions
and can manifest as reduced social engagement and motivation.
Cognitive symptoms are marked by changes in memory and attention.
The prognosis for schizophrenia remains poor as 30 percent of
patients live independently and only 10 to 20 percent maintain
full-time employment. There is a desperate need for new treatments
in schizophrenia that not only address positive, negative, and
cognitive symptoms of the disease, but are also safer than existing
medicines.
About Wellcome
Wellcome exists to improve health for everyone by helping great
ideas to thrive. We're a global charitable foundation, both
politically and financially independent. We support scientists and
researchers, take on big problems, fuel imaginations and spark
debate.
About Karuna Pharmaceuticals
Karuna is a clinical-stage drug development company targeting
muscarinic receptors for the treatment of psychosis and cognition
across central nervous system (CNS) disorders, including
schizophrenia and Alzheimer's disease. Karuna's lead product
candidate, KarXT, consists of xanomeline, a novel muscarinic
acetylcholine receptor agonist that has demonstrated efficacy in
placebo-controlled human trials in schizophrenia and Alzheimer's
disease, and trospium chloride, an FDA-approved and
well-established muscarinic receptor antagonist that has been shown
not to enter the CNS. Karuna has demonstrated improved tolerability
of KarXT vs xanomeline in a placebo-controlled human study and is
currently conducting a Phase 1 study using a proprietary
co-formulation of xanomeline and trospium. A Phase 2 trial of
safety and efficacy in people with schizophrenia is expected to
begin in the third quarter of 2018. Karuna, an affiliate of
PureTech Health (LSE: PRTC), has a worldwide exclusive license for
xanomeline and has a patent portfolio more broadly covering
selective muscarinic targeting enabled by the KarXT approach. For
more information, visit www.karunapharma.com.
About PureTech Health
PureTech Health (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, PureTech
Health 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 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 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.
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014.
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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