atai Life Sciences (Nasdaq: ATAI) ("atai") today announced
that it has observed encouraging interim data from the
first 8-patient cohort of its Phase 2a trial, demonstrating
potential pro-cognitive effects of its compound
RL-007, a cholinergic, glutamatergic, and GABA type B receptor
modulator, for Cognitive Impairment Associated with
Schizophrenia (CIAS).
These early data have led atai to commit additional financial
resources, enabling an accelerated clinical development timeline
for RL-007, even ahead of completion of the ongoing Phase 2a
trial.
The interim Phase 2a readout reported promising
assessments for the 8-patient cohort from two
quantitative biomarkers, qEEG (quantitative
electroencephalogram) and ERP (evoked-response
potential) and indicated changes that are consistent with
improved cognition. CIAS is a major unmet need for those
living with schizophrenia, with no effective treatments currently
available.1 Full results of the current Phase 2a trial are expected
by the end of 2021.
The financial boost by atai will enable immediate initiation of
planning stages for the next clinical trial, ahead of schedule and
prior to the Phase 2a’s conclusion. The atai RL-007 trials are
being conducted by Recognify Life Sciences,
an atai Life Sciences platform company.
“With these data, from the interim analysis of the ongoing Phase
2a trial, we are encouraged to accelerate the overall development
of RL-007 for CIAS,” said Matthew Pando, PhD, CEO and Co-Founder
of Recognify Life Science. “I would like to express my deepest
gratitude to the patient volunteers who have supported our clinical
trial thus far. I believe that, with continued support, we have the
potential to bring benefit to patients living with schizophrenia
and its often very challenging cognitive impacts.”
“We believe that, although preliminary, these promising data
give us confidence to further support and expedite the clinical
trajectory for RL-007 and we look forward to the full data set,”
said Florian Brand, CEO and Co-Founder of atai Life
Sciences. “With its unique mechanism of action, we think that
RL-007 has potential to address a major unmet need in terms of
addressing the cognitive deficits that can be so debilitating for
people with schizophrenia.”
Schizophrenia is a mental health disorder primarily
characterized by hallucinations, delusions, and disordered
thinking. This condition effects over 21 million people globally
and approximately 3.5 million people in the United
States.2,3
CIAS is a major unmet need for those living with
schizophrenia. Cognitive deficits are frequently present in
patients diagnosed with schizophrenia, and such deficits contribute
to the marked disability associated with this condition, impacting
the ability of patients to carry out some basic living tasks, like
pursuing education and holding down a job.4
About the RL-007 Phase 2a trialThe ongoing
Phase 2a trial is a single-arm, single blind, multiple dose study
of oral RL-007 administered to subjects with schizophrenia who are
currently stable on a protocol-allowed antipsychotic regimen.
Subjects continue their antipsychotic treatment without change
throughout the course of this study. All subjects receive four
doses of placebo followed by six doses of RL-007, although subjects
are blinded to the dose strength or sequence of active and placebo
capsules.
About RL-007
RL-007 has a unique mechanism of action, impacting
both cholinergic and gamma-aminobutyric acid type B (GABA type
B) receptor systems, which are both are central to learning
and memory functions. With its unique mechanism of
action, we believe 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 mission is to bridge the gap between what the mental
healthcare system currently provides and what patients need. atai
has offices in New York, London, and Berlin. For more information,
please visit www.atai.life.
References:1. 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;9:91.2. 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):1195-1203.3. Wander C.
Schizophrenia: opportunities to improve outcomes and reduce
economic burden through managed care. Am J Manag Care. 2020;26(3
Suppl):S62-S68.4. Bowie CR, Harvey PD. Cognitive deficits and
functional outcome in schizophrenia. Neuropsychiatr Dis Treat.
2006;2(4):531-536.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Forward-looking
statements include express or implied statements relating to, among
other things, statements regarding the potential outcome of
Recognify’s ongoing 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; the commercialization of our current
product candidates and any other product candidates that we may
identify and pursue, if approved, including our ability to
successfully build a specialty sales force and commercial
infrastructure to market our current product candidates and any
other product candidates that we may identify and purse; the timing
of, and our ability to obtain and maintain, regulatory approvals;
our business strategy and plans; potential acquisitions; and the
plans and objectives of management for future operations and
capital expenditures. Forward-looking statements are neither
promises nor guarantees, but involve known and unknown risks and
uncertainties that could cause actual results to differ materially
from those projected, including, without limitation, the important
factors discussed under the caption “Risk Factors” in atai's
prospectus pursuant to Rule 424(b) filed with the U.S. Securities
and Exchange Commission (“SEC”) on June 21, 2021, and in atai's
other filings with the SEC. 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 atai believes 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. atai disclaims any obligation or
undertaking to update or revise any forward-looking statements
contained in this press release (or to conform these statements to
actual results or revised expectations), other than to the extent
required by applicable law.
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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