TIDMPRTC
PureTech Health PLC
23 June 2020
23 June 2020
PureTech Health plc
PureTech Founded Entity Karuna Announces Positive Outcome of
End-of-Phase 2 Meeting with the FDA for KarXT for the Treatment of
Acute Psychosis in Patients with Schizophrenia
One additional Phase 3 trial, along with previously completed
Phase 2 trial, would be acceptable to support an efficacy claim for
a New Drug Application filing
Karuna on track to initiate Phase 3 programme, including
efficacy and open-label long-term safety trials, by the end of
2020
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,
Karuna, today announced next steps in the clinical programme
evaluating KarXT for the treatment of acute psychosis in patients
with schizophrenia following the completion of a successful
End-of-Phase 2 meeting with the US Food & Drug Administration
(FDA). The outcome of the meeting supports the progression of KarXT
into Phase 3 development. Karuna remains on track to initiate the
Phase 3 programme by the end of 2020.
The End-of-Phase 2 discussion was supported by pre-clinical and
clinical efficacy data, including results from the previously
completed positive Phase 2 trial evaluating KarXT in patients with
schizophrenia. In the Phase 2 trial, KarXT demonstrated robust
efficacy on primary and key secondary outcome measures and was
generally safe and well tolerated.
A founder of Karuna and co-inventor of the KarXT programme,
PureTech now holds 4,739,897 shares of Karuna common stock, which
is equal to 18.1% of Karuna's outstanding shares, and has a right
to royalty payments on net sales of any commercialised product
covered by a license granted by PureTech to Karuna.
The full text of the announcement from Karuna is as follows:
Karuna Therapeutics Announces Positive Outcome of End-of-Phase 2
Meeting with the FDA for KarXT for the Treatment of Acute Psychosis
in Patients with Schizophrenia
One additional Phase 3 trial, along with previously completed
Phase 2 trial, would be acceptable to support an efficacy claim for
a New Drug Application filing
Company on track to initiate Phase 3 programme, including
efficacy and open-label long-term safety trials, by the end of
2020
BOSTON - Jun. 23, 2020 - Karuna Therapeutics, Inc. (NASDAQ:
KRTX), an innovative clinical-stage biopharmaceutical company
committed to developing novel therapies with the potential to
transform the lives of people with disabling and potentially fatal
neuropsychiatric disorders and pain, today announced next steps in
the clinical programme evaluating KarXT for the treatment of acute
psychosis in patients with schizophrenia following the completion
of a successful End-of-Phase 2 meeting with the US Food & Drug
Administration (FDA). The outcome of the meeting supports the
progression of KarXT into Phase 3 development. The Company remains
on track to initiate the Phase 3 programme by the end of 2020.
"We look forward to progressing KarXT into Phase 3 clinical
development for the treatment of schizophrenia following a
constructive End-of-Phase 2 meeting with the FDA," said Andrew
Miller, Ph.D., chief operating officer and founder of Karuna
Therapeutics. "Our team is dedicated to truly advancing the
standard of care in schizophrenia, and we believe our planned Phase
3 programme sets us on course to potentially offer a new, unique
and mechanistically differentiated treatment option relative to
current therapies. We are pleased to be working closely with the
FDA as we prepare to advance our lead clinical programme into Phase
3 by the end of the year."
The End-of-Phase 2 discussion was supported by pre-clinical and
clinical efficacy data, including results from the previously
completed positive Phase 2 trial evaluating KarXT in patients with
schizophrenia. In the Phase 2 trial, KarXT demonstrated robust
efficacy on primary and key secondary outcome measures and was
generally safe and well tolerated.
The Company and FDA aligned on key elements of the Phase 3
programme to support a New Drug Application (NDA) filing, including
the initiation of additional trials evaluating the efficacy and
long-term safety of KarXT. The formal minutes from the meeting
confirmed that the completed Phase 2 trial, along with one
successful Phase 3 efficacy and safety trial, and additional safety
data to meet regulatory requirements, would be acceptable to
support an NDA filing.
The Company plans to initiate two five-week inpatient trials
evaluating the efficacy and safety of KarXT for the treatment of
acute psychosis in adults with schizophrenia. Both trials will
share key characteristics of the completed Phase 2 trial, such as
duration of treatment, patient population and primary outcome
measure, among other aspects. The first Phase 3 trial is expected
to commence by the end of 2020. This five-week, 1:1 randomised,
flexible-dose, double-blind, placebo-controlled, inpatient trial
will enrol approximately 250 adults in the US and evaluate the
change in Positive and Negative Syndrome Scale total score at Week
5 of KarXT versus placebo as the primary outcome measure. Details
of the second efficacy trial will be finalised by the end of 2020,
with initiation expected in the first half of 2021.
In conjunction with the short-term efficacy and safety trials,
the Company will collect long-term, open-label data to assess the
safety and tolerability of KarXT in patients for up to one year in
an outpatient setting. Following the five-week, double-blind,
inpatient phase in both efficacy trials, patients may enter a
52-week open-label safety and tolerability extension in which all
patients will receive active treatment. The Company currently plans
to also conduct a separate 52-week open-label trial evaluating the
long-term safety of KarXT in adults with schizophrenia who have not
been enroled in the inpatient trials. This trial is expected to
begin the first half of 2021. Data from these trials will be used
to support regulatory safety requirements for an NDA filing.
As previously shared, the Company is well capitalised, with
sufficient funding to support development activities for the NDA
filing. Additional details regarding the development plan,
including anticipated completion timelines, will be shared in the
second half of 2020.
About KarXT
KarXT, a proprietary oral modulator of muscarinic cholinergic
receptors, is Karuna's lead product candidate that combines
xanomeline, a novel muscarinic agonist, with trospium, an
FDA-approved muscarinic antagonist that does not appreciably cross
the blood-brain-barrier, to preferentially stimulate muscarinic
receptors in the central nervous system (CNS). This novel product
candidate, if approved, has the potential to usher in a new
treatment paradigm and dramatically impact patients with
schizophrenia and other psychotic disorders by providing a
differentiated mechanism of action relative to current D2 dopamine
and serotonin receptor-targeting antipsychotic drugs.
About Schizophrenia
Schizophrenia is a chronic, disabling disorder typically
diagnosed in late teenage years or early adulthood. Characterised
by recurring episodes of psychosis requiring long-term treatment
with antipsychotic drugs in most patients, it affects more than 21
million people worldwide and 2.7 million Americans (0.5% - 1.0% of
US population).
At least one-third of patients with schizophrenia fail to
respond to current treatments, with 74% of patients discontinuing
within 18 months of initiation. People with schizophrenia have a
10- to 15-year reduction in life expectancy and struggle to
maintain meaningful interpersonal relationships. The World Health
Organization ranks psychosis as the third-most disabling medical
condition in the world.
About Karuna
Karuna is a clinical-stage biopharmaceutical company committed
to developing and delivering first-in-class therapies with the
potential to transform the lives of people with CNS disorders -
which remain among the most disabling and potentially fatal
disorders worldwide. Galvanised by the understanding that today's
neuropsychiatric and pain management patients deserve better,
Karuna's mission is to harness the untapped potential of the
brain's complex biology in pursuit of novel therapeutic pathways
that will advance the standard of care. For more information,
please visit karunatx.com .
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 been cleared by the US Food and Drug Administration
(FDA). 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, 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
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
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June 23, 2020 08:48 ET (12:48 GMT)
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