atai Life Sciences (“atai” or the “Company”) (NASDAQ: ATAI), a
clinical-stage biopharmaceutical company aiming to transform the
treatment of mental health disorders today announced the initiation
of the Phase 1 proof-of-concept (PoC) clinical trial of intranasal
INB-01, a sol-gel based, excipient (drug-delivery) technology.
This is a Phase 1 two-stage, open-label, randomized study of the
safety, tolerability, and effective brain delivery of INB-01.
INB-01 or placebo will be administered to subjects using the Aptar
Nasal Drug Delivery Device. Topline results are expected in H1
2023.
Traditional oral or intravenous drug delivery methods can be
problematic in the treatment of central nervous system (CNS)
disorders. When drugs are delivered via these peripheral methods,
the blood–brain barrier restricts the entry of therapeutic agents
to the CNS, thereby decreasing drug efficacy.
A potential solution is direct-to-brain delivery through the
nose. This method has the potential to be a non-invasive
administration route and may offer additional advantages such as
ease of administration, increased patient compliance, lower dose
requirements, rapid onset of action, and minimized systemic
exposure, which may reduce the risk of peripheral toxicity.
Our INB-01 technology is designed to deliver pharmaceutical
compounds as a liquid at room temperature, which becomes a gel
instantaneously in the nasal cavity. The novel technology has been
successfully utilized with both water-soluble and insoluble
compounds and extracts. Prior to launching this PoC trial in
humans, dosing of INB-01 has shown positive results in animals when
measuring levels of INB-01 in the brain as well as MRI imaging of
the brain. These results are a promising predictor for the use of
INB-01 in human subjects for intranasal direct-to-brain drug
delivery.
“Exploring the mechanism of drug delivery is an opportunity for
us to further enhance the treatment experience,” said Florian
Brand, Co-Founder, and CEO of atai Life Sciences. “INB-01 has the
potential to provide superior drug uptake via the nose-brain
barrier, reducing dose administered and dosing frequency. We are
confident this will help patients and healthcare practitioners by
easing administration, dosing, and providing faster relief to
improve compliance.”
Dr. Majed Fawaz, Vice President, Chemistry, Manufacturing &
Controls at atai, further commented, “INB-01 offers a novel
direct-to-brain delivery technology that will support the lifecycle
of atai’s drug development pipeline. We are thrilled to commence
the Phase 1 proof-of-concept trial for INB-01. This is the first
important step in understanding the safety, tolerability, and brain
delivery potential of INB-01 in healthy adult subjects prior to
pairing it with active pharmaceutical ingredients.”
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
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 InnarisBio and future activities thereunder, the
potential of INB-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 MalievskySenior Director, External
AffairsPR@atai.life
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