TIDMPRTC
RNS Number : 2831V
PureTech Health PLC
08 August 2022
8 August 2022
PureTech Health plc
PureTech Founded Entity Karuna Therapeutics Announces Positive
Results from Phase 3 EMERGENT-2 Trial of KarXT in Schizophrenia
Trial met primary endpoint, with KarXT demonstrating a
statistically significant 9.6-point reduction in PANSS Total Score
compared to placebo at Week 5 (p<0.0001)
Trial also met key secondary endpoints, demonstrating
statistically significant reductions in positive and negative
symptoms of schizophrenia, as measured by the PANSS positive, PANSS
negative and PANSS negative Marder factor subscales
KarXT was generally well tolerated, with a side effect profile
substantially consistent with prior trials of KarXT in
schizophrenia
Karun plans to submit a New Drug Application (NDA) with the U.S.
Food & Drug Administration (FDA) in mid-2023
Conference call and webcast to take place today at 8:00 a.m. EDT
/ 1:00 p.m. BST
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the
"Company"), a clinical-stage biotherapeutics company, noted today
that its Founded Entity, Karuna Therapeutics, Inc. (NASDAQ: KRTX)
("Karuna") announced positive topline results from its Phase 3
EMERGENT-2 trial evaluating the efficacy, safety, and tolerability
of its lead investigational therapy, KarXT (xanomeline-trospium),
in adults with schizophrenia. The trial met its primary endpoint,
with KarXT demonstrating a statistically significant and clinically
meaningful 9.6-point reduction in the Positive and Negative
Syndrome Scale (PANSS) total score compared to placebo (-21.2 KarXT
vs. -11.6 placebo, p<0.0001) at Week 5 (Cohen's d effect size of
0.61). KarXT also demonstrated an early and sustained statistically
significant reduction of symptoms, as assessed by PANSS total
score, starting at Week 2 and maintained such reduction through all
timepoints in the trial.
Karuna will hold a webcast and conference call this morning at
8:00 a.m. ET to share results from an interim analysis of its Phase
3 EMERGENT-2 trial of KarXT for the treatment of schizophrenia. A
live webcast of the presentation will be available on the Investor
Relations page of Karuna's website at investors.karunatx.com. A
replay of the webcast will also be archived for up to 30 days on
Karuna's website following the conference.
As of August 3, 2022, PureTech owned approximately 5.5% of
Karuna's outstanding stock. A founder of Karuna and co-inventor of
the KarXT program, PureTech has a right to royalty payments of 3%
of net sales of any commercialized product covered by the license
agreement, as well as 20% sublicense income covered by the license
agreement. The license agreement covers key territories including
the United States, European Union, and Japan. PureTech is also
eligible to receive certain milestone payments upon the achievement
of regulatory approvals.
The full text of the announcement from Karuna is as follows:
Karuna Therapeutics Announces Positive Results from Phase 3
EMERGENT-2 Trial of KarXT in Schizophrenia
Trial met primary endpoint, with KarXT demonstrating a
statistically significant 9.6-point reduction in PANSS Total Score
compared to placebo at Week 5 (p<0.0001)
Trial also met key secondary endpoints, demonstrating
statistically significant reductions in positive and negative
symptoms of schizophrenia, as measured by the PANSS positive, PANSS
negative and PANSS negative Marder factor subscales
KarXT was generally well tolerated, with a side effect profile
substantially consistent with prior trials of KarXT in
schizophrenia
The Company plans to submit a New Drug Application (NDA) with
the U.S. Food & Drug Administration (FDA) in mid-2023
Conference call and webcast to take place today at 8:00 a.m.
ET
BOSTON-- Karuna Therapeutics, Inc. (NASDAQ: KRTX), a
clinical-stage biopharmaceutical company driven to create and
deliver transformative medicines for people living with psychiatric
and neurological conditions, today announced positive topline
results from its Phase 3 EMERGENT-2 trial evaluating the efficacy,
safety, and tolerability of its lead investigational therapy, KarXT
(xanomeline-trospium), in adults with schizophrenia. The trial met
its primary endpoint, with KarXT demonstrating a statistically
significant and clinically meaningful 9.6-point reduction in the
Positive and Negative Syndrome Scale (PANSS) total score compared
to placebo (-21.2 KarXT vs. -11.6 placebo, p<0.0001) at Week 5
(Cohen's d effect size of 0.61). KarXT also demonstrated an early
and sustained statistically significant reduction of symptoms, as
assessed by PANSS total score, starting at Week 2 and maintained
such reduction through all timepoints in the trial.
"We are thrilled that these topline results from the Phase 3
EMERGENT-2 trial confirm what was seen in our Phase 2 EMERGENT-1
trial and underscore the potential for KarXT, with its novel and
unique mechanism of action, to redefine what successful treatment
looks like for the 21 million people living with schizophrenia
worldwide, and potentially usher in the first new class of medicine
for these patients in more than 50 years," said Steve Paul, M.D.,
chief executive officer, president and chairman of Karuna
Therapeutics. "These results represent our second positive
registrational trial. We look forward to continuing to gather
long-term safety data to support our submission of a New Drug
Application with the U.S. Food and Drug Administration for KarXT as
a treatment for schizophrenia, which we expect to occur in
mid-2023."
KarXT also met key secondary endpoints in the Phase 3 EMERGENT-2
trial, demonstrating a statistically significant reduction in both
positive symptoms (e.g., hallucinations or delusions) and negative
symptoms (e.g., difficulty enjoying life or withdrawal from others)
of schizophrenia as measured by the PANSS positive, PANSS negative
and PANSS negative Marder factor subscales. Results at Week 5
include:
-- 2.9-point reduction in the PANSS positive subscale with KarXT
compared to placebo (-6.8 KarXT vs. -3.9 placebo, p<0.0001).
-- 1.8-point reduction in the PANSS negative subscale with KarXT
compared to placebo (-3.4 KarXT vs. -1.6 placebo, p=0.0055).
-- 2.2-point reduction in the PANSS negative Marder factor
subscale with KarXT compared to placebo (-4.2 KarXT vs. -2.0
placebo, p=0.0022).
KarXT was generally well tolerated. Overall discontinuation
rates were similar between KarXT and placebo groups (25% vs. 21%).
The overall treatment-emergent adverse events (TEAEs) rate for
KarXT and placebo was 75% and 58%, respectively. Discontinuation
rates related to TEAEs were similar between KarXT (7%) and placebo
(6%). Equal rates of serious TEAEs were observed between KarXT and
placebo (2% in each group) and included suicidal ideation,
worsening of schizophrenia symptoms, and appendicitis. None of the
serious TEAEs were determined to be drug related. The most common
TEAEs (>5%) in the KarXT arm were all mild to moderate in
severity and included constipation, dyspepsia, nausea, vomiting,
headache, increases in blood pressure, dizziness, gastroesophageal
reflux disease (acid reflux), abdominal discomfort, and diarrhea.
Mean blood pressure measures were similar between KarXT and placebo
throughout the trial, and no syncopal events were observed. In the
subset of patients with a TEAE of blood pressure increases, mean
blood pressure at endpoint was similar to baseline and did not lead
to trial discontinuation. Similar to prior trials, an increase in
heart rate was associated with KarXT treatment and decreased in
magnitude by the end of the trial. Consistent with EMERGENT-1,
KarXT was not associated with common problematic side effects of
current treatments, including sedation (somnolence), weight gain,
and extrapyramidal symptoms.
"Despite the number of available treatment options, there
continues to be a tremendous unmet need in the treatment of
schizophrenia, placing an immense burden on both patients and their
caregivers," said Rishi Kakar, M.D., chief scientific officer,
Segal Trials and lead investigator of the Phase 3 EMERGENT-2 trial.
"These data build on the growing body of clinical evidence
supporting the potential of KarXT as a new and differentiated
approach for schizophrenia, demonstrating notable improvements
across both positive and negative symptoms, while not being
associated with common problematic side-effects of current
therapies, such as weight gain, sedation and movement disorders.
This unique profile of KarXT has the potential to provide a new
meaningful treatment option for our patients and their families
beyond the current standard of care."
The EMERGENT program consists of the completed positive Phase 2
EMERGENT-1 and Phase 3 EMERGENT-2 trials, as well as three ongoing
trials evaluating the acute efficacy and long-term safety of KarXT
(EMERGENT-3, EMERGENT-4, and EMERGENT-5). Topline data from the
Phase 3 EMERGENT-3 trial are expected in the first quarter of 2023.
The data from our EMERGENT program will be used to support
submission of an NDA with the U.S. FDA for KarXT as a treatment for
schizophrenia, which is expected in mid-2023. Additional analysis
of data from the Phase 3 EMERGENT-2 trial is ongoing, with plans to
present these results at future medical meetings.
Conference Call and Webcast Information
Karuna will hold a webcast and conference call this morning at
8:00 a.m. ET to share results from an interim analysis of its Phase
3 EMERGENT-2 trial of KarXT for the treatment of schizophrenia.
A live webcast of the presentation will be available on the
Investor Relations page of Karuna's website at
investors.karunatx.com. A replay of the webcast will also be
archived for up to 30 days on Karuna's website following the
conference.
About the Phase 3 EMERGENT-2 Trial
The Phase 3 EMERGENT-2 trial is a double-blind,
placebo-controlled, five-week, inpatient trial evaluating the
efficacy, safety, and tolerability of our lead investigational
therapy, KarXT, as compared to placebo in adults with schizophrenia
in the United States. The primary endpoint was change from baseline
in Positive and Negative Syndrome Scale (PANSS) total score, a
scale for measuring schizophrenia symptom severity, of KarXT
compared to placebo at Week 5. Key secondary endpoints included
change from baseline in PANSS positive, PANSS negative and PANSS
negative Marder factor subscale of KarXT compared to placebo at
Week 5.
A total of 252 adults (between the ages of 18-65 years) with a
confirmed diagnosis of schizophrenia who were experiencing symptoms
of psychosis enrolled in the trial. Patients were randomized 1:1 to
receive either a flexible dose of KarXT (n=126) or placebo (n=126)
two times a day (BID) for five weeks. On Days 1-2, patients
received a dose of 50/20 KarXT (50mg xanomeline/20mg trospium) BID
or matching placebo. On Day 3, patients escalated to a dose of
100/20 BID, and starting on Day 8, patients could increase to
125/30 BID based on tolerability. In the trial, 81% of patients on
KarXT compared to 90% on placebo titrated to the highest dose level
(125/30).
About KarXT
KarXT (xanomeline-trospium) is an oral, investigational
M1/M4-preferring muscarinic agonist in development for the
treatment of psychiatric and neurological conditions, including
schizophrenia and psychosis in Alzheimer's disease. Comprised of
muscarinic agonist xanomeline and muscarinic antagonist trospium,
it is designed to preferentially stimulate muscarinic receptors in
the central nervous system. KarXT is the first potential medicine
of its kind with a truly new and unique dual mechanism that does
not rely on the dopaminergic or serotonergic pathway to treat
symptoms of serious mental illness. This approach has the potential
to provide a differentiated therapy, and, if approved, to
beneficially impact the lives of millions of people with serious
mental illness.
About Schizophrenia
Schizophrenia is a chronic and often debilitating mental illness
that impacts how one thinks, feels, and behaves. It is
characterized by positive symptoms (hallucinations and delusions),
negative symptoms (difficulty enjoying life and withdrawal from
others), and cognitive impairment. Together these symptoms can
severely impact quality of life and productivity, with only 10% of
people gainfully employed and many struggling to meet adult
milestones - such as living independently. The life expectancy of
people living with schizophrenia is reduced by 10-20 years compared
to the general population. Schizophrenia affects approximately 21
million people worldwide and is most commonly treated with
antipsychotics. Unfortunately, many people with schizophrenia
continue to experience limited efficacy or problematic side effects
while on antipsychotic therapy, and up to 74% of patients
discontinue medication before 18 months. When schizophrenia
treatment is discontinued, it can lead to impacts on health
including relapse, hospitalization, and longer time to
remission.
About Karuna Therapeutics
Karuna Therapeutics is a clinical-stage biopharmaceutical
company driven to create and deliver transformative medicines for
people living with psychiatric and neurological conditions. At
Karuna, we understand there is a need for differentiated and more
effective treatments that can help patients navigate the challenges
presented by serious mental illness. Utilizing our extensive
knowledge of neuroscience, we are harnessing the untapped potential
of the brain in pursuit of novel pathways to develop medicines that
make meaningful differences in peoples' lives. For more
information, please visit www.karunatx.com.
Forward-Looking Statements
This press release contains forward looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended, including statements regarding our expectations about the
timing of our ongoing and planned clinical trials and regulatory
filings, our goals to develop and commercialize our product
candidates, and other statements identified by words such as
"could," "expects," "intends," "may," "plans," "potential,"
"should," "will," "would," or similar expressions and the negatives
of those terms. Forward looking statements are not promises or
guarantees of future performance, and are subject to a variety of
risks and uncertainties, many of which are beyond our control, and
which could cause actual results to differ materially from those
contemplated in such forward-looking statements. These factors
include risks related to our limited operating history, our ability
to obtain necessary funding, our ability to generate positive
clinical trial results for our product candidates and other risks
inherent in clinical development, the timing and scope of
regulatory approvals, changes in laws and regulations to which we
are subject, competitive pressures, risks relating to business
interruptions resulting from the coronavirus (COVID-19) pandemic,
and other risks set forth under the heading "Risk Factors" of our
Annual Report on Form 10-K for the year ended December 31, 2021.
Our actual results could differ materially from the results
described in or implied by such forward looking statements.
Forward-looking statements speak only as of the date hereof, and,
except as required by law, we undertake no obligation to update or
revise these forward-looking statements.
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated
to discovering, developing and commercializing highly
differentiated medicines for devastating diseases, including
inflammatory, fibrotic and immunological conditions, intractable
cancers, lymphatic and gastrointestinal diseases and neurological
and neuropsychological disorders, 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 27
therapeutics and therapeutic candidates, including two that have
received both U.S. FDA clearance and European marketing
authorization, as of the date of PureTech's most recently filed
Annual Report and corresponding Form 6-K. All of the underlying
programs and platforms that resulted in this pipeline of
therapeutic candidates were initially identified or discovered and
then advanced by the PureTech team through key validation points
based on unique insights in immunology and drug development.
For more information, visit www.puretechhealth.com or connect
with us on Twitter @puretechh.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements contained in this press release that do not
relate to matters of historical fact should be considered
forward-looking statements, including without limitation statements
regarding Karuna's future business and development strategy related
to KarXT, the potential therapeutic benefits of Karuna's KarXT,
PureTech's eligibility to receive potential payments, including
sublicense payments and royalties on any sales of KarXT, under its
patent license agreement with Karuna, and Karuna's and PureTech's
future prospects, development plans, and strategies. The
forward-looking statements are based on current expectations and
are subject to known and unknown risks, uncertainties and other
important factors that could cause actual results, performance and
achievements to differ materially from current expectations,
including, but not limited to, those risks, uncertainties and other
important factors described under the caption "Risk Factors" in our
Annual Report on Form 20-F for the year ended December 31, 2021
filed with the SEC and in our other 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 and regulatory requirements, we
disclaim any obligation to update or revise these forward-looking
statements, whether as a result of new information, future events
or otherwise.
Contact:
PureTech
Public Relations
publicrelations@puretechhealth.com
Investor Relations
IR@puretechhealth.com
EU Media
Ben Atwell, Rob Winder
+44 (0) 20 3727 1000
ben.atwell@FTIconsulting.com
U.S. Media
Nichole Sarkis
+1 774 278 8273
nichole@tenbridgecommunications.com
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