atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), which is
developing EMP-01, a 3,4-methylenedioxy-methamphetamine (MDMA)
derivative for the treatment of post-traumatic stress disorder
(PTSD) and other indications, announced today its Phase 1 study has
received regulatory and ethics approvals required from Medsafe and
HDEC, respectively, to initiate participant enrollment.
The Phase 1 randomized, double-blind, placebo-controlled study
is designed to evaluate the safety and tolerability of
single-ascending doses of EMP-01 in healthy adult participants, as
well as assess the usability and acceptability of the IDEA-1 app in
delivering “set and setting” content to participants in preparation
for their EMP-01 administration. This study also includes a range
of behavioral assessments that, in conjunction with the PK and
safety readouts, are expected to inform the design of and doses
tested in future Phase 2 clinical trials of EMP-01.
In the U.S. alone, an estimated 9.3 million people meet the
criteria for a PTSD diagnosis according to the National Institute
of Health. At present, the only FDA-approved treatments for PTSD
are two selective serotonin reuptake inhibitors (SSRIs), paroxetine
and sertraline. Evidence shows that two-thirds of patients either
do not respond or have only a partial response to these
medications.
MDMA itself is an amphetamine derivative that possesses complex
pharmacology and is believed to act by increasing the release of
monoamines like serotonin, norepinephrine, and dopamine in the
brain, as well as stimulating neurohormonal activity. Studies
show that this activity may result in the anxiolytic, prosocial,
and empathic responses commonly associated with the approximately
six-hour experience. As a result, MDMA is often classified as an
entactogen rather than a typical psychedelic.
EmpathBio is focused on developing MDMA derivatives with
different pharmacological profiles than MDMA. These modifications
are designed to separate the entactogenic effects of MDMA from some
of the known side effects, specifically its stimulant-associated
effects. This may result in an improved safety profile compared to
MDMA in the treatment of PTSD populations with comorbidities
including hypertension, history of stroke, and cardiovascular
disease. If successful, such an approach could help minimize some
of the transient physiological changes caused by MDMA and
potentially expand the PTSD patient pool medically eligible for the
therapy.
“The need for new interventions for PTSD is critical given the
current lack of effective treatments for those suffering from this
debilitating mental health disorder,” said Florian Brand, CEO of
atai Life Sciences. “We are thrilled to have received the necessary
approvals for the initiation of the Phase 1 trial for EMP-01 in
order to further progress the potential development of this
promising new therapy.”
“Data on MDMA-assisted psychotherapy strongly suggests its
potential for the treatment of PTSD,” said Glenn Short, Senior Vice
President, Early Development of atai Life Sciences. “However, we
are focused on refining MDMA’s entactogenic pharmacology to provide
a greater therapeutic index. This study is a critical step towards
ensuring that entactogen-assisted therapy is available to everyone
who is struggling with PTSD.”
atai anticipates topline results in H2 2023 for this Phase 1
study.
About atai Life Sciences atai Life
Sciences is a clinical-stage biopharmaceutical company aiming to
transform the treatment of mental health disorders. Founded in 2018
as a response to the significant unmet need and lack of innovation
in the mental health treatment landscape, atai is dedicated to
acquiring, incubating, and efficiently developing innovative
therapeutics to treat depression, anxiety, addiction, and other
mental health disorders.
By pooling resources and best practices, atai aims to
responsibly accelerate the development of new medicines across its
companies to achieve clinically meaningful and sustained behavioral
change in mental health patients.
atai's vision is to heal mental health disorders so that
everyone, everywhere can live a more fulfilled life. For more
information, please visit www.atai.life.
About EmpathBio EmpathBio is a biotech
company dedicated to developing 3,4-methylenedioxymethamphetamine
derivatives in conjunction with digital therapeutics to deliver
efficient, scalable treatments to patients on their own
terms.
Forward-Looking Statements This press
release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995, as amended.
The words “believe,” “may,” “will,” “estimate,” “continue,”
“anticipate,” “intend,” “expect,” “initiate,” “could,” “would,”
“project,” “plan,” “potentially,” “preliminary,” “likely,” and
similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these words. Forward-looking statements include express or implied
statements relating to, among other things: statements regarding
the trials by EmpathBio and future activities thereunder, the
potential of EMP-01, the success, cost and timing of development of
our product candidates, including the progress of preclinical and
clinical trials and related milestones; our business strategy and
plans; potential acquisitions; and the plans and objectives of
management for future operations and capital expenditures. The
forward-looking statements in this press release are neither
promises nor guarantees, and you should not place undue reliance on
these forward-looking statements because they involve known and
unknown risks, uncertainties, and other factors, many of which are
beyond our control and which could cause actual results, levels of
activity, performance, or achievements to differ materially from
those expressed or implied by these forward-looking
statements.
The forward-looking statements in this press release are neither
promises nor guarantees, and you should not place undue reliance on
these forward-looking statements. These forward-looking statements
are subject to a number of risks, uncertainties, and assumptions
that could cause actual results to differ materially from those
expressed or implied by the forward-looking statements, including
without limitation: we are a clinical-stage biopharmaceutical
company and have incurred significant losses since our inception,
and we anticipate that we will continue to incur significant losses
for the foreseeable future; we will require substantial additional
funding to achieve our business goals, and if we are unable to
obtain this funding when needed and on acceptable terms, we could
be forced to delay, limit or terminate our product development
efforts; our limited operating history may make it difficult to
evaluate the success of our business and to assess our future
viability; we have never generated revenue and may never be
profitable; clinical and preclinical development is uncertain, and
our preclinical programs may experience delays or may never advance
to clinical trials; we rely on third parties to assist in
conducting our clinical trials and some aspects of our research and
preclinical testing, and those clinical trials, including progress
and related milestones, may be impacted by several factors
including the failure by such third parties to meet deadlines for
the completion of such trials, research, or testing, changes to
trial sites and other circumstances; we cannot give any assurance
that any of our product candidates will receive regulatory
approval, which is necessary before they can be commercialized;
third parties may claim that we are infringing, misappropriating or
otherwise violating their intellectual property rights, the outcome
of which would be uncertain and may prevent or delay our
development and commercialization efforts; and a pandemic,
epidemic, or outbreak of an infectious disease, such as the
COVID-19 pandemic, may materially and adversely affect our
business, including our preclinical studies, clinical trials, third
parties on whom we rely, our supply chain, our ability to raise
capital, our ability to conduct regular business and our financial
results. These and other important factors described in the section
titled “Risk Factors” in our Annual Report on Form 10-K for the
fiscal year ended December 31, 2021 filed with the Securities and
Exchange Commission (“SEC”), our Quarterly Reports on Form 10-Q and
our Current Reports on Form 8-K, as updated by our subsequent
filings with the SEC, may cause our actual results, performance, or
achievements to differ materially and adversely from those
expressed or implied by the forward-looking statements. Any such
forward-looking statements represent management’s estimates as of
the date of this press release. While we may elect to update such
forward-looking statements at some point in the future, we disclaim
any obligation to do so, even if subsequent events cause our views
to change.
Contact Information Investor
Contact: Stephen Bardin Chief Financial OfficerEmail:
IR@atai.life
Media Contact:Allan Malievsky Senior Director, External
AffairsEmail: PR@atai.life
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