atai Life Sciences Announces Completion of Phase 1 Study of VLS-01 in Healthy Participants
02 Octobre 2023 - 10:13PM
atai Life Sciences (NASDAQ: ATAI) (“atai”), a
clinical-stage biopharmaceutical company aiming to transform the
treatment of mental health disorders, announced the completion of
the Phase 1 study of VLS-01 in healthy participants.
“We are pleased to report the completion of the
Phase 1 study of VLS-01, in which we demonstrated a supportive
PK/PD profile of our proprietary OTF formulation of DMT,” said
Florian Brand, CEO and Co-Founder of atai. “We plan to test a
further optimized version of our OTF formulation in a forthcoming
Phase 1b prior to initiating a Phase 2 study in TRD.”
The Phase 1 study was designed to evaluate the
safety, tolerability, pharmacokinetics (PK) and pharmacodynamics
(PD) of VLS-01 applied to the sublingual and buccal surfaces
compared to intravenous (IV) DMT. The study enrolled a total of 74
healthy participants across three parts. The third part of the
study evaluated VLS-01 administered and dosed as follows:
sublingual 80mg (n=8), buccal 80mg with backing layer (n=10), and
buccal 160mg with backing layer (n=8).
VLS-01 was well-tolerated with a favorable safety
profile, and dose-dependent increases in exposure were observed.
VLS-01 administration also resulted in subjective effects in most
participants across doses. The company observed that participants
that received 160mg of VLS-01 with a backing layer via buccal
administration experienced the most robust and consistent increases
in exposure and subjective effects compared to the other OTF
cohorts, with results comparable to those seen in the IV cohort of
DMT.
The company now plans to progress VLS-01 into a
Phase 1b study in healthy participants. The study is expected to
explore doses up to 160 mg with an optimized OTF formulation that
incorporates taste masking, an intrinsic backing layer, and
enhancements designed to increase permeability, with goals of
further improving the participant experience and pharmacokinetics.
The company has submitted a protocol to regulatory authorities and
expects to enroll the first participant in a Phase 1b study in 1H
2024.
About VLS-01
VLS-01 is a proprietary OTF formulation of
N,N-dimethyltryptamine (DMT). Pharmacologically, DMT is a partial
agonist of the 5-HT 1A/2A/2C receptors, characterized by an
intrinsically short duration of psychedelic effect, with a serum
half-life estimated at less than 10 minutes. Clinical evidence
suggests IV DMT administration results in rapid-acting
antidepressant effects in patients with major depressive disorder
(MDD). The company’s proprietary OTF formulation is designed to
eliminate the need for parenteral administration, provide improved
PK compared to such routes of administration, and result in a
psychedelic effect that resolves by approximately 45 minutes post
dosing, thus allowing for—and maximizing the therapeutic potential
of—a 2 hour in-clinic patient visit.
About atai Life Sciences
atai is a clinical-stage biopharmaceutical company
aiming to transform the treatment of mental health disorders and
was founded as a response to the significant unmet need and lack of
innovation in the mental health treatment landscape. atai is
dedicated to 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 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. The words “believe,” “may,” “will,” “estimate,”
“continue,” “anticipate,” “intend,” “expect,” “could,” “would,”
“project,” “plan,” “potentially,” “preliminary,” “likely,” and the
negative of these terms and similar expressions are intended to
identify forward-looking statements, though not all forward-looking
statements use these words or expressions. All statements contained
in this press release other than statements of historical fact
should be considered forward-looking statements, including without
limitation our expectations and projections regarding the success,
cost, and timing of development of VLS-01 (DMT) and related
studies, and our business strategy and plans.
Because forward-looking statements are subject to
risks and uncertainties, actual results may differ materially from
those expressed or implied by such forward-looking statements.
These risks and uncertainties include, among others: our limited
operating history, historical losses, and anticipation that we will
continue to incur significant losses for the foreseeable future; we
will require substantial additional funding to achieve our business
goals, including the development and any commercialization of our
product candidates; we have never generated revenue and may never
be profitable; our product candidates contain controlled
substances, the use of which may generate public controversy;
clinical and preclinical development is uncertain, and our programs
may experience delays or may never advance to clinical trials; our
reliance on third parties to assist in conducting our clinical
trials and impact to such trials based on factors including failure
by third parties to meet trial or testing deadlines; our reliance
on qualified therapists working at third-party clinical trial sites
to administer certain of our product candidates and failure to
recruit and retain a sufficient number of therapists; the timing
and outcome of regulatory review and/or approvals, which are
necessary prior to commercialization; research and development of
drugs targeting the central nervous system, or CNS, is particularly
difficult, and it can be difficult to predict and understand why a
drug has a positive effect on some patients but not others;
significant competition; obtaining, maintaining and protecting our
intellectual property; restricted operating activity as a result of
covenants in any financing arrangements, including our loan
agreement with Hercules Capital, Inc.; our aggregate tax burden
based on our management and operational activity. These
forward-looking statements are subject to a number of important
factors that could cause actual results to differ materially from
those in the forward-looking statements, including the risks,
uncertainties, and assumptions described in our Form 10-K for the
year ended December 31, 2022, filed with the Securities and
Exchange Commission (“SEC”) and our quarterly reports on Form 10-Q,
as may be updated by other filings we file with or furnish to the
SEC.
Any forward-looking statements made herein speak
only as of the date of this press release. Except as required by
applicable law, we undertake no obligation to update any of these
forward-looking statements for any reason after the date of this
press release or to conform these statements to actual results or
revised expectations.
Contact Information
Investors:atai Investor RelationsIR@atai.life
Media:atai Public RelationsPR@atai.life
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