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 program,
including efficacy and open-label long-term safety trials, by the
end of 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 program 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 U.S. 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
program 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 program 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 program 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
program 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 randomized,
flexible-dose, double-blind, placebo-controlled, inpatient trial
will enroll approximately 250 adults in the U.S. 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 finalized 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 enrolled 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 capitalized, 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. Characterized 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 U.S. 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. Galvanized 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.
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 our cash resources, the timing of
advancing of our planned clinical trials and regulatory filings,
interim trial results, 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, the timing and
scope of regulatory approvals, changes in laws and regulations to
which we are subject, competitive pressures, our ability to
identify additional product candidates, 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, 2019.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200623005333/en/
Investor Alexis Smith 518-338-8990
asmith@karunatx.com
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