atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), a clinical-stage
biopharmaceutical company aiming to transform the treatment of
mental health disorders, today announced the U.S. Food and Drug
Administration (FDA) has given Investigational New Drug (IND)
clearance to conduct a clinical DDI study of PCN-101 (R-ketamine).
atai plans to initiate the study early this year through its
platform company Perception Neuroscience.
The unique properties of PCN-101 could offer a differentiated
profile to currently available antidepressants and address key
patient needs, including the potential of rapid action and
anti-suicidal effect. Rapid onset of action is particularly
important in this patient population, but frontline selective
serotonin reuptake inhibitors (SSRIs) can take up to 12 weeks
before providing maximal benefit, while suicidality affects as much
as 30% of treatment-resistant depression (TRD) patients at least
once during their lifetime.1-3
In preclinical animal models of depressive behavior, R-ketamine
has demonstrated the potential to offer longer durability and a
potentially more favorable safety and tolerability profile than
S-ketamine, which could enable the potential for at-home use.4,5 In
addition, a third-party, open-label study observed a rapid, durable
antidepressant response and limited dissociative side effects in
patients with TRD after a single intravenous dose of another
formulation of R-ketamine.6
“We see great promise in PCN-101 as a potentially rapid-acting
anti-depressant with a more favorable safety and tolerability
profile than S-ketamine, which could enable at-home use,” said
Florian Brand, CEO and Co-Founder of atai Life Sciences. “With
today’s IND clearance, we are excited to continue assessing the
therapeutic potential of PCN-101 in the U.S., where, like elsewhere
in the world, many patients struggle with treatment-resistant
depression and desperately need innovative therapeutic
options.”
“TRD represents a large percentage of people with severe,
difficult to treat depression who have failed to sufficiently
respond to at least two different antidepressant treatments,”
explained Terence Kelly, PhD, CEO of Perception Neuroscience, the
atai Life Sciences platform company conducting the trials. “We
believe that PCN-101 has the potential to offer a differentiated
therapeutic effect, in terms of both efficacy and ease of
administration, for clinicians and patients, as a potentially
rapid-acting antidepressant. We look forward to progressing its
clinical development.”
An estimated 100 million people live with TRD globally,
representing a third of people with depression, who are
undertreated or unresponsive to available treatment options.7,8 In
addition to its impact on patients, families, and caregivers, TRD
severely impacts 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.9,10
This clinical DDI trial will advance alongside an existing Phase
2a proof-of-concept trial in TRD, recently initiated in Europe.11
Additionally, atai anticipates running a bioavailability study in
2022, which is designed to bridge the IV formulation to a
subcutaneous formulation of PCN-101, supporting the potential for
self-administration.
About the clinical DDI studyThe clinical study
is an open-label, 2-cohort, fixed-sequence, drug-drug interaction
study to evaluate the effects of CYP450 inhibition on the
pharmacokinetics of PCN-101 in healthy adult subjects. atai will
use the results of this study in conjunction with clinical
pharmacokinetic data to advance the development of PCN-101 in
TRD.
About PCN-101Perception Neuroscience is
developing PCN-101 (R-ketamine) for the treatment of TRD. 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 (RAAD) activity and anti-suicidal effects.
Pharmacologically, PCN-101 is a non-competitive
N-methyl-D-aspartate (NMDA) receptor antagonist. Nonclinical
depression model studies in rodents suggest that R-ketamine could
possess more durable effects and favorable safety and tolerability
profile. Further supporting the potential of R-ketamine, an
open-label clinical study has demonstrated rapid, durable response
and limited dissociative side effects in TRD patients after a
single intravenous dose.
About Perception Neuroscience, IncPerception
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.
About atai Life Sciencesatai is a
clinical-stage biopharmaceutical company aiming to transform the
treatment of mental health disorders. atai was 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.
atai's business model combines funding, technology, scientific
and regulatory expertise with a focus on psychedelic therapy and
other drugs with differentiated safety profiles and therapeutic
potential. By pooling resources and best practices, atai aims to
responsibly accelerate the development of new medicines across its
companies, seeking to effectively treat and ultimately heal mental
health disorders.
atai's vision is to heal mental health disorders so that
everyone, everywhere can live a more fulfilled life. atai has
offices in New York, London, and Berlin. For more information,
please visit www.atai.life.
References:
- Tew JD Jr, Mulsant BH, Houck PR, et al. Impact of prior
treatment exposure on response to antidepressant treatment in late
life. Am J Geriatr Psychiatry. 2006;14(11):957-965.
- Bergfeld IO, Mantione M, Figee M, Schuurman PR, Lok A, Denys D.
Treatment-resistant depression and suicidality. J Affect Disord.
2018;235:362-367.
- Dong M, Lu L, Zhang L, et al. Prevalence of suicide attempts in
bipolar disorder: a systematic review and meta-analysis of
observational studies. Epidemiol Psychiatr Sci. 2019;29:e63.
- Zanos P, Moaddel R, Morris PJ, et al. NMDAR
inhibition-independent antidepressant actions of ketamine
metabolites. Nature. 2016;533(7604):481-486.
- Yang C, Shirayama Y, Zhang JC, et al. R-ketamine: a rapid-onset
and sustained antidepressant without psychotomimetic side effects
[published correction appears in Transl Psychiatry. 2020 Aug
21;10(1):295]. Transl Psychiatry. 2015;5(9):e632.
- Leal GC, Bandeira ID, Correia-Melo FS, et al. Intravenous
arketamine for treatment-resistant depression: open-label pilot
study. Eur Arch Psychiatry Clin Neurosci. 2021;271(3):577-582.
- Pandarakalam JP. Challenges of Treatment-resistant Depression.
Psychiatr Danub. 2018;30(3):273-284.
- World Health Organization. Depression.
https://www.who.int/news-room/fact-sheets/detail/depression.
Published September 13, 2021. Accessed January 10, 2022.
- Ivanova JI, Birnbaum HG, Kidolezi Y, Subramanian G, Khan SA,
Stensland MD. Direct and indirect costs of employees with
treatment-resistant and non-treatment-resistant major depressive
disorder. Curr Med Res Opin. 2010;26(10):2475-2484.
- Amos TB, Tandon N, Lefebvre P, et al. Direct and Indirect Cost
Burden and Change of Employment Status in Treatment-Resistant
Depression: A Matched-Cohort Study Using a US Commercial Claims
Database. J Clin Psychiatry. 2018;79(2):17m11725.
- Perception Neuroscience initiates Phase 2a study of PCN-101
(R-ketamine) for treatment resistant depression. [Press release]
https://ir.atai.life/news-releases/news-release-details/perception-neuroscience-initiates-phase-2a-study-pcn-101-r.
Published September 14, 2021. Accessed January 10, 2022.
Forward Looking StatementsThis 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 Perception and future activities thereunder, the
potential of PCN-101 (R-ketamine), 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.
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 subject to a number of risks,
uncertainties, and assumptions, 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; our product
candidates contain controlled substances, the use of which may
generate public controversy; 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 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; 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; 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; we face
significant competition in an environment of rapid technological
and scientific change; 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; a change in our effective place of
management may increase our aggregate tax burden; we identified
material weaknesses in connection with our internal control over
financial reporting; 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. Other risk factors include the
important factors described in the section titled “Risk Factors” in
our final prospectus, dated June 17, 2021, filed with the
Securities and Exchange Commission (“SEC”) pursuant to Rule 424(b)
under the Securities Act, and in our other filings with the SEC,
that may cause our actual results, performance or achievements to
differ materially and adversely from those expressed or implied by
the forward-looking statements.
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
For atai:
Media Contact:Camilla DormerVP, Communications, atai Life
SciencesEmail: camilla@atai.life
Investor Contact:Chad MesserVP, Investor Relations, atai Life
SciencesEmail: chad@atai.life
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