atai Life Sciences (Nasdaq: ATAI) ("atai"), a clinical-stage
biopharmaceutical company aiming to transform the treatment of
mental health disorders, today announced positive topline data from
its Phase 2a study of RL-007 for Cognitive Impairment Associated
with Schizophrenia (CIAS).
The 32-patient, single-arm, single-blind study demonstrated a
clinically meaningful pro-cognitive profile for RL-007, based on
analysis of general cognition and episodic memory. Additionally,
the trial showed changes in quantitative electroencephalogram
(qEEG) that are consistent with previous results of a prior study
of healthy volunteers. Together, the results support atai’s
decision to progress RL-007 to a double-blind, placebo-controlled
Phase 2 trial focused on cognition.
The topline Phase 2a data showed dose-related improvements on
exploratory cognitive endpoints. These included the Brief
Assessment of Cognition in Schizophrenia, Symbol Coding Test
(Symbol Coding) and Hopkins Verbal Learning Task (HVLT), focusing
on general cognitive function and episodic memory, respectively.1,2
The dose-responsive improvement of Symbol Coding and HVLT
replicated the previously observed cognitive bi-phasic dose
response of RL-007. Importantly, Symbol Coding is a highly
sensitive cognitive endpoint in CIAS patients, has a high
correlation with patient outcome, and is a key component of the
Measurement and Treatment Research to Improve Cognition in
Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB™).3
In addition to the pro-cognitive effects, a dose dependent
response in qEEG was observed, with the greatest increases seen in
20mg and 40mg doses of RL-007. The qEEG data demonstrated salient
increases in amplitude in the alpha band (up to 17% increase in
normalized, baseline adjusted band power) and in the alpha-slow
wave index (up to 21% increase), both markers of alertness believed
to correlate with aspects of cognition.4
Notably, these findings recapitulate promising results from a
previous study of RL-007 in a human model of cognitive impairment
utilizing a scopolamine challenge. This previous trial observed
similar qEEG responses and changes in a word recall task within the
same dose range. Recognify Life Sciences, an atai Life Sciences
platform company, is conducting the current and upcoming RL-007
trials in CIAS.
“The impact of cognitive impairment in schizophrenia can be
debilitating and limit the ability of patients to conduct everyday
tasks. These Phase 2a results further reinforce our belief in
RL-007 to provide benefit in this challenging condition,” said
Florian Brand, CEO and Co-Founder of atai Life Sciences.
“These exciting Phase 2a results extend previously observed
clinical activities of RL-007 to CIAS patients and support
advancement to the next clinical trial, which will be designed to
assess cognitive benefits in a double-blind, placebo-controlled
manner,” said Matthew Pando, PhD, CEO and Co-Founder
of Recognify Life Sciences. “These results demonstrate
RL-007’s potential in CIAS, a major area of unmet patient need that
presently lacks approved therapies.”
Following these promising findings, atai has committed to
initiate a randomized, double-blind, placebo-controlled,
proof-of-concept Phase 2 study of RL-007. In addition to symbol
coding and HVLT, this trial will also include other cognitive tests
taken from the MCCB.
Schizophrenia is a mental health disorder affecting over 21
million people globally and approximately 3.5 million people in the
United States.5,6 While some symptoms, like delusions and
hallucinations can be managed with antipsychotic medications, over
80% of patients suffer from significant cognitive impairment, which
has no approved treatment and can be severely debilitating.7,8 Such
cognitive deficits contribute significantly to the disability
associated with this condition, impacting the ability of those with
schizophrenia to carry out basic tasks necessary for independent
living.9
RL-007 Key Opinion Leader Event, January 18,
2022atai will host an event featuring a presentation by
Richard S.E. Keefe, PhD, of Duke University. Dr Keefe will discuss
the current treatment landscape and unmet medical need in treating
patients with CIAS, and will be followed by Matthew Pando,
PhD, CEO and Co-Founder of Recognify Life
Sciences, who will discuss the design of this recently completed
Phase 2a trial for RL-007 and the preliminary topline data. The
event is scheduled for January 18, 2022, at 12 PM ET. You are
required to register in advance for the webcast, here. For those
who are unable to listen at this time, a replay of the call will be
available by clicking here.
About the RL-007 Phase 2a trial
The Phase 2a trial was a single-arm, single blind, multiple-dose
study of oral RL-007 administered to subjects with schizophrenia. A
total of four, 8-patient cohorts (32 subjects in total) were
enrolled, testing the 10mg, 20mg, 40mg, and 80mg doses of RL-007,
administered 3 times/day. Patients enrolled had to be on a stable
dosing regimen of a protocol-allowed antipsychotic regimen, and
they continued their antipsychotic treatment without change
throughout the course of this study. All subjects received four
doses of placebo followed by six doses of RL-007, although subjects
were blinded to the dose strength and sequence of active and
placebo capsules.
About RL-007
RL-007 is a neuromodulator that potently enhances synaptic
plasticity by modulating excitatory
neurotransmission and the cholinergic and
gamma-aminobutyric acid type B (GABA type B) receptor systems, all
of which are central to learning and memory functions. With its
unique mechanism of action, atai believes RL-007 may enhance
pro-cognitive functioning, such as neuronal signaling, learning,
and memory.
About atai Life Sciences
atai 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:1. Jaeger J. Digit Symbol
Substitution Test: The Case for Sensitivity Over Specificity in
Neuropsychological Testing. J Clin Psychopharmacol.
2018;38(5):513-519.
2. Benedict RHB, Schretlen D, Groninger L, Brandt J. Hopkins
verbal learning test - Revised: Normative data and analysis of
inter-form and test-retest reliability. Clinical Neuropsychologist.
1998;12(1):43-55.
3. MATRICS Assessment, Inc. MCCB Neuropsychological Assessment.
http://www.matricsinc.org/mccb/. Accessed December 13, 2021.
4. Ramsay IS, Lynn PA, Schermitzler B, Sponheim SR. Individual
alpha peak frequency is slower in schizophrenia and related to
deficits in visual perception and cognition [published correction
appears in Sci Rep. 2021 Oct 11;11(1):20497]. Sci Rep.
2021;11(1):17852.
5. Charlson FJ, Ferrari AJ, Santomauro DF, et al. Global
Epidemiology and Burden of Schizophrenia: Findings From the Global
Burden of Disease Study 2016. Schizophr Bull.
2018;44(6):1195-1203.
6. Wander C. Schizophrenia: opportunities to improve outcomes
and reduce economic burden through managed care. Am J Manag Care.
2020;26(3 Suppl):S62-S68.
7. Reichenberg A, Harvey PD, Bowie CR, et al. Neuropsychological
function and dysfunction in schizophrenia and psychotic affective
disorders. Schizophr Bull. 2009;35(5):1022-1029.
8. Hsu WY, Lane HY, Lin CH. Medications Used for Cognitive
Enhancement in Patients With Schizophrenia, Bipolar Disorder,
Alzheimer's Disease, and Parkinson's Disease. Front Psychiatry.
2018;9:91.
9. Bowie CR, Harvey PD. Cognitive deficits and functional
outcome in schizophrenia. Neuropsychiatr Dis Treat.
2006;2(4):531-536.
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 outcome of Recognify’s Phase 2a trial for its lead compound,
RL-007, 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
Media Contact:Camilla DormerVP,
CommunicationsEmail: camilla@atai.life
Investor Contact:Chad MesserVP, Investor
RelationsEmail: chad@atai.life
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