TIDMPRTC
PureTech Health PLC
23 June 2021
23 June 2021
PureTech Health plc
PureTech Founded Entity Karuna Therapeutics Announces Results
from Phase 1b Trial Evaluating the Safety and Tolerability of KarXT
in Healthy Elderly Volunteers
Karuna to initiate a Phase 2 trial evaluating KarXT in
dementia-related psychosis in the first half of 2022
Results suggest that KarXT can be administered to elderly
volunteers at doses which achieve xanomeline blood levels similar
to those reported in the Phase 2 EMERGENT-1 trial in adults with
schizophrenia while maintaining a favorable tolerability
profile
The majority of healthy elderly volunteers in the Phase 1b trial
were titrated to xanomeline doses of 150 to 200 mg when dosed with
KarXT
Safety and tolerability profile in Phase 1b trial in healthy
elderly volunteers consistent with prior trials of KarXT
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the
"Company"), a clinical-stage biotherapeutics company dedicated to
discovering, developing and commercializing highly differentiated
medicines for devastating diseases, is pleased to note that its
Founded Entity, Karuna , today announced data from its completed
Phase 1b trial evaluating the safety and tolerability of KarXT
(xanomeline-trospium) in healthy elderly volunteers. Karuna had
previously announced a preliminary analysis of data from the first
two cohorts in the trial earlier this year. Based on results from
the Phase 1b trial in healthy elderly volunteers, Karuna plans to
initiate a Phase 2 trial evaluating KarXT in dementia-related
psychosis in the first half of 2022.
As of April 30, 2021, PureTech's percentage ownership of Karuna
was approximately 8.2 percent on an outstanding voting share basis.
PureTech Health has a right to royalty payments as a percentage of
net sales from Karuna.
The full text of the announcement from Karuna is as follows:
Karuna Therapeutics Announces Results from Phase 1b Trial
Evaluating the Safety and Tolerability of KarXT in Healthy Elderly
Volunteers
Company to initiate a Phase 2 trial evaluating KarXT in
dementia-related psychosis in the first half of 2022
Results suggest that KarXT can be administered to elderly
volunteers at doses which achieve xanomeline blood levels similar
to those reported in the Phase 2 EMERGENT-1 trial in adults with
schizophrenia while maintaining a favorable tolerability
profile
The majority of healthy elderly volunteers in the Phase 1b trial
were titrated to xanomeline doses of 150 to 200 mg when dosed with
KarXT
Safety and tolerability profile in Phase 1b trial in healthy
elderly volunteers consistent with prior trials of KarXT
BOSTON--(BUSINESS WIRE)--Jun. 23, 2021 -- 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 data from its completed Phase 1b trial evaluating the
safety and tolerability of KarXT (xanomeline-trospium) in healthy
elderly volunteers. The Company had previously announced a
preliminary analysis of data from the first two cohorts in the
trial earlier this year. Based on results from the Phase 1b trial
in healthy elderly volunteers, the Company plans to initiate a
Phase 2 trial evaluating KarXT in dementia-related psychosis in the
first half of 2022.
The placebo-controlled, inpatient Phase 1b dose-ranging trial
consisted of three cohorts, each enrolling 16 healthy elderly
volunteers, randomized 3:1 to receive KarXT or placebo. As part of
the flexible dosing protocol, a volunteer's dose was increased if
they were tolerating KarXT well at the time of the potential dose
increase, as determined by a clinician. In the trial, the majority
of healthy elderly volunteers were titrated to xanomeline doses of
150 to 200 mg when dosed with KarXT three times per day. As
previously reported, pharmacokinetic data from Cohorts 1 and 2
demonstrated that healthy elderly volunteers achieved mean
xanomeline blood levels comparable to, or slightly higher than, the
mean xanomeline blood levels reported in the Phase 2 EMERGENT-1
trial evaluating KarXT in adults with schizophrenia. The Company
plans to evaluate pharmacokinetic data from Cohort 3, once
available. Previous trials of KarXT have demonstrated that the
current formulation of KarXT results in xanomeline exposures, or
blood levels, that are approximately 10% greater than blood levels
seen in earlier trials of xanomeline alone.
The treatment-related adverse events (AEs) were similar to those
observed in prior trials of KarXT, and a majority (>80%) were
rated mild in severity. One serious AE of urinary retention was
reported in Cohort 1. The Company believes the report of urinary
retention was related to a higher dose of trospium used in Cohort 1
compared to doses used in Cohorts 2 and 3, where urinary retention
was not observed. No serious or severe AEs were observed in Cohorts
2 and 3. Consistent with prior trials of KarXT, blood pressure in
healthy elderly volunteers receiving KarXT was similar to placebo,
and no syncopal events were observed. Heart rate increases observed
in the trial were also consistent with prior trials of KarXT.
Data from the Phase 1b trial suggest that a lower dose ratio of
trospium to xanomeline, compared to the ratios used in Phase 1
trials in healthy adult volunteers and in the Phase 2 EMERGENT-1
trial evaluating KarXT in adults with schizophrenia, was better
tolerated by healthy elderly volunteers.
"We are encouraged that the data from our Phase 1b healthy
elderly volunteers trial suggest that potentially therapeutic doses
of KarXT can be administered to elderly adults while maintaining a
favorable tolerability profile," said Stephen Brannan, M.D., chief
medical officer of Karuna Therapeutics. "Results from the third
cohort provide additional data as we finalize the dosing and
titration protocol for our Phase 2 trial in dementia-related
psychosis."
"The results from the Phase 1b trial in healthy elderly
volunteers, as well as a prior Phase 2 study demonstrating the
potential of xanomeline to treat and prevent psychosis in patients
with Alzheimer's disease, give us confidence in the potential
utility of KarXT for the treatment of dementia-related psychosis,"
added Steve Paul, M.D., chief executive officer, president and
chairman of the board of Karuna Therapeutics. "These results
support the progression of KarXT into a Phase 2 clinical trial for
the treatment of dementia-related psychosis, which we plan to
commence in the first half of 2022."
About KarXT
KarXT, a proprietary oral modulator of muscarinic cholinergic
receptors, is Karuna's lead product candidate. It 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. 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 Karuna
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 these severe and disabling disorders. 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 advancing of our 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, 2020.
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 26 therapeutics and therapeutic
candidates, including two that have received FDA clearance and
European marketing authorization, as of the date of PureTech's most
recently filed Annual Report on Form 20-F. 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 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.
Cautionary Note Regarding Forward-Looking Statements
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, expectations regarding the potential of KarXT 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
Allison Mead Talbot Ben Atwell, Rob Winder
+1 617 651 3156 +44 (0) 20 3727 1000
amt@puretechhealth.com ben.atwell@FTIconsulting.com
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END
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June 23, 2021 08:28 ET (12:28 GMT)
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