atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), which is
developing VLS-01, a form of N,N-dimethyltryptamine (DMT) for the
treatment of treatment-resistant depression (TRD), announced today
the dosing of the first subject in their Phase 1 SAD trial of
VLS-01.
The trial is a randomized, double-blind, placebo-controlled
study designed to evaluate the relative bioavailability of buccal
versus IV formulations, the safety, and tolerability of VLS-01
administered by both routes, as well as pharmacodynamics of DMT
using qEEG and other measures. Buccal VLS-01 is formulated to
provide a psychedelic experience lasting 30 to 45 minutes, thus
potentially allowing for a shorter clinic visit compared to many
other psychedelic compounds that may require a patient to be
monitored for four or more hours.
The trial includes the companion use of atai’s IDEA-1 digital
therapeutic app to provide contextual “(mind)set-and-setting” prior
to dosing, as well as behavioral activation therapy, group therapy,
and patient monitoring post-dosing. These behavioral assessments,
in conjunction with the pharmacokinetic and safety readouts, are
expected to inform the design of and doses tested in future Phase 2
clinical trials of VLS-01.
An estimated 100 million people live with TRD globally – or a
third of people with depression – who are undertreated or
unresponsive to available treatment options. In addition to its
impact on patients, families, and caregivers, TRD significantly
burdens healthcare systems and payers. Direct medical costs for TRD
patients are estimated to be two times higher than for non-TRD
major depressive disorder (MDD) patients, with an average of twice
the number of inpatient visits and hospital stays that are over
one-third longer.
“Exploring novel approaches to drug delivery can potentially
simplify in-clinic administration and allow greater pharmacokinetic
control of the psychedelic experience and its overall duration of
hallucinogenic effects,” said Srinivas Rao, Chief Scientific
Officer of atai Life Sciences. “We’re pleased to see this trial
move forward as we establish the safety and tolerability of our
compound.”
“A practical approach to DMT administration would give people
access not only to the pharmacological benefits of DMT but will
also afford them time to explore the personal insights from their
experiences with therapists,” said Glenn Short, Senior Vice
President, Early Development of atai Life Sciences. “Given the
scale of the depression crisis, the impact on patients and families
could be enormous.”
atai anticipates Phase 1 topline results in H1 2023.
About atai Life Sciencesatai 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
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 Viridia Life Sciences and future activities
thereunder, the potential of VLS-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 BardinChief Financial
OfficerIR@atai.life
Media Contact: Allan Malievsky Senior Director, External Affairs
PR@atai.life
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