atai Life Sciences Announces Results from Phase 2a Trial of PCN-101
(R-ketamine) for Treatment-Resistant Depression
atai Life Sciences (NASDAQ: ATAI) (“atai” or “the Company”), a
clinical-stage biopharmaceutical company focused on mental health,
announced that, while PCN-101 (R-ketamine) demonstrated signals of
efficacy across all timepoints out to two weeks, Perception
Neuroscience’s Phase 2a clinical trial did not meet its primary
endpoint of a statistically significant change from baseline in
participants’ MADRS (Montgomery-Åsberg Depression Rating Scale)
score at 24 hours compared to placebo.
The Phase 2a proof-of-concept trial was a two-week, randomized,
double-blind, placebo-controlled multi-center study assessing the
safety, tolerability and efficacy of a single IV administration of
PCN-101. 102 TRD patients were enrolled across three arms – 30mg,
60mg and placebo.
On the primary endpoint of MADRS at 24 hours, the mean change
from baseline was -15.3 for PCN-101 60mg compared to -13.7 for
placebo (-1.6 pbo-adj; p-value 0.5). However, the single 60mg dose
of PCN-101 showed an efficacy signal at each timepoint over the
2-week timeframe of the study.
Key secondary endpoints included a proportion of patients
defined as responders, meaning patients who experienced 50%
improvement from baseline in MADRS, and a proportion of patients in
remission, defined as a total MADRS score of less than 10. Despite
seeing greater response and remission rates in the 60mg arm, the
trial did not meet statistical significance at any timepoint on
these secondary measures.
PCN-101 was generally well-tolerated with rates of sedation and
dissociation comparable to placebo.
“We thank all the patients, families, caregivers, and
investigators for their support and participation in the PCN-101
Phase 2a trial,” said Florian Brand, CEO and Co-Founder of
atai.
PCN-101 demonstrated an encouraging safety profile and signals
of efficacy across all timepoints despite not achieving statistical
significance on the primary endpoint. atai will further evaluate
the PCN-101 data in more detail over the next weeks and will work
with its subsidiary Perception Neuroscience to explore next steps,
including but not limited to seeking strategic partnership
options.
PCN-101 Phase 2a Study Design
The Phase 2a proof-of-concept trial was a randomized,
double-blind, placebo-controlled multi-center study assessing the
safety, tolerability and efficacy of IV PCN-101 (R-ketamine) in 102
patients with TRD across three arms. These patients – all of whom
had previously failed at least two rounds of antidepressants –
received a single IV dose of either placebo, 30 mg, or 60 mg of
PCN-101 adjunctively to their existing treatment regimen.
Patients were assessed for a change in depressive symptomatology
using the Montgomery-Åsberg Depression Rating Scale (MADRS) at
intervals over 14 days, with the primary endpoint at 24 hours
post-dose. Dissociation and sedation were measured using the
Clinician-Administered Dissociative States Scale (CADSS) and the
Modified Observer’s Alertness/Sedation Scale (MOAA/S),
respectively.
About Perception Neuroscience, Inc
Perception Neuroscience is a New York City-based clinical-stage
biopharmaceutical company committed to the mission of providing
more effective treatment solutions for serious psychiatric
disorders. It is developing PCN-101 (R-ketamine) for the treatment
of TRD. In March 2021, the company announced a collaboration and
licensing agreement with Otsuka Pharmaceutical Co., Ltd. for rights
in Japan to PCN-101. Perception Neuroscience is a majority-owned
subsidiary of atai Life Sciences.
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. 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”).
The words “believe,” “may,” “will,” “estimate,” “continue,”
“anticipate,” “intend,” “expect,” “initiate,” “could,” “would,”
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similar expressions are intended to identify forward-looking
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these words. All statements in this press release other than
statements of historical fact are forward-looking statements,
including, express or implied statements relating to, among other
things: statements regarding the trials, results and our
expectations related to any subsequent steps concerning the PCN-101
(R-ketamine) studies, data, or related plans and objectives of
management for future operations, capital expenditures and capital
allocation. 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
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which are beyond our control and which could cause actual results,
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The forward-looking statements in this press release are neither
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that could cause actual results to differ materially from those
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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
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be forced to delay, limit or terminate our product development
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viability; we have never generated revenue and may never be
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results. These and other important factors described in the section
titled “Risk Factors” in our Annual Report on Form 10-K for the
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Company Contact
Allan MalievskySenior Director, External AffairsPR@atai.life |
IR@atai.life
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