atai Life Sciences Announces First Subject Dosed in the Phase 1
IV-to-Subcutaneous Bridging Study of PCN-101 (R-Ketamine)
atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage
biopharmaceutical company aiming to transform the treatment of
mental health disorders, announced that the first subject has been
dosed in Perception Neuroscience’s Phase 1
intravenous-to-subcutaneous bridging study of PCN-101 (R-ketamine).
This Phase 1 open-label study is designed to assess the safety,
tolerability, and pharmacokinetic profile of 60mg, 90mg and 120mg
of PCN-101 delivered subcutaneously as compared to 60mg of PCN-101
delivered intravenously (IV). The trial will enroll approximately
16 healthy volunteers across the four cohorts and is expected to be
completed in the middle of 2023.
In January 2023, atai announced results from the Phase 2a
proof-of-concept study evaluating a single IV administration of
PCN-101 in patients with treatment-resistant depression across
three arms – 30mg, 60mg and placebo. While the results did not
reach statistical significance on the primary endpoint, PCN-101
demonstrated an encouraging safety profile and signals of efficacy
across all timepoints out to two weeks, potentially indicating a
sustained duration of effect.
This IV-to-subcutaneous bridging study will potentially inform
dosing regimens of the new subcutaneous formulation that may
optimize the therapeutic index—the balance of safety, tolerability
and efficacy—of PCN-101 in future studies, thereby supporting
further exploration of the potential of R-ketamine as a rapid
acting anti-depressant for at-home use.
atai continues to work with Perception Neuroscience to explore
strategic partnership options.
About Perception Neuroscience, Inc.
Perception Neuroscience is a New York City- based
biopharmaceutical company committed to developing therapies for
neuropsychiatric diseases. Perception’s mission is to provide
substantially more effective treatment solutions to serious
psychiatric disorders. The company is a majority-owned subsidiary
of atai Life Sciences AG.
PCN-101 is a single isomer of ketamine and belongs to a new
generation of glutamate receptor modulators with the potential for
rapid-acting antidepressant activity and anti-suicidal effects.
Pharmacologically, PCN-101 is a non-competitive
N-methyl-D-aspartate (NMDA) receptor antagonist. Depression model
studies in rodents suggest that R-ketamine could possess more
durable effects than S-ketamine and a more favorable safety and
tolerability profile.
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. We intend such forward-looking statements to be covered by
the safe harbor provisions for forward-looking statements contained
in Section 27A of the Securities Act of 1933, as amended (the
“Securities Act”), and Section 21E of the Securities Exchange Act
of 1934, as amended (the “Exchange Act”). All statements contained
in this press release other than statements of historical fact
should be considered forward-looking statements, including without
limitation statements regarding the success, cost, and timing of
development of PCN-101 (R-ketamine) and related studies; our
business strategy and plans, including potential partnerships and
other strategic arrangements; and the plans and objectives of
management for future operations and capital expenditures.
We have based these forward-looking statements largely on our
current expectations and projections about future events and trends
that we believe may affect our financial condition, results of
operations, business strategy, short-term and long-term business
operations and objectives, and financial needs. These
forward-looking statements are neither promises nor guarantees, and
are subject to a number of important factors that could cause
actual results to differ materially from any future results,
performance or achievements 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 expect to incur
losses for the foreseeable future and may never be profitable; if
we are unable to obtain funding when needed and on acceptable
terms, we could be forced to delay, limit or discontinue 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 rely on third parties to assist in
conducting our clinical trials and some aspects of our research and
preclinical testing, and those third parties may not perform
satisfactorily, including failing to meet deadlines for the
completion of such trials, research, or testing; we currently rely
on qualified therapists working at third-party clinical trial sites
to administer certain of our product candidates in our clinical
trials and we expect this to continue upon approval, if any, of our
current or future product candidates, and if third-party sites fail
to recruit and retain a sufficient number of therapists or
effectively manage their therapists, our business, financial
condition and results of operations would be materially harmed; our
product candidates are in preclinical or clinical development,
which is a lengthy and expensive process with uncertain outcomes,
and we cannot give any assurance that any of our product candidates
will receive regulatory approval, which is necessary before they
can be commercialized; 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; the production and
sale of our product candidates may be considered illegal or may
otherwise be restricted due to the use of controlled substances,
which may also have consequences for the legality of investments
from foreign jurisdictions; we face significant competition in an
environment of rapid technological and scientific change, and there
is a possibility that our competitors may achieve regulatory
approval before we do or develop therapies that are safer, more
advanced or more effective than ours, which may negatively impact
our ability to successfully market or commercialize any product
candidates we may develop and ultimately harm our financial
condition; if we are unable to obtain and maintain sufficient
intellectual property protection for our existing product
candidates or any other product candidates that we may identify, or
if the scope of the intellectual property protection we currently
have or obtain in the future is not sufficiently broad, our
competitors could develop and commercialize product candidates
similar or identical to ours, and our ability to successfully
commercialize our existing product candidates and any other product
candidates that we may pursue may be impaired; 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; our future success depends on our
ability to retain key employees, directors, consultants and
advisors and to attract, retain and motivate qualified personnel;
as a result of covenants to our loan agreement with Hercules
Capital, Inc., our operating activities may be restricted and we
may be required to repay the outstanding indebtedness in the event
of a breach by us, or an event of default thereunder, which could
have a materially adverse effect on our business; if we fail to
maintain an effective system of disclosure controls and internal
control over financial reporting our ability to produce timely and
accurate financial statements or comply with applicable regulations
could be impaired; our business is subject to economic, political,
regulatory and other risks associated with international
operations; 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, and other risks, uncertainties,
and assumptions described under “Risk Factors” in Item 1A of Part
I, “Management’s Discussion and Analysis of Financial Condition and
Results of Operations” in Item 7 of Part II and elsewhere in our
Form 10-K for the year ended December 31, 2022, filed with the
Securities and Exchange Commission.
Any forward-looking statements made herein speak only as of the
date of this press release, and you should not rely on
forward-looking statements as predictions of future events.
Although we believe that the expectations reflected in the
forward-looking statements are reasonable, we cannot guarantee that
the future results, performance, or achievements reflected in the
forward-looking statements will be achieved or will occur. 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
Investor Contact: Stephen Bardin Chief Financial Officer
IR@atai.life
Media Contact: Allan Malievsky Senior Director, External Affairs
PR@atai.life
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