atai Life Sciences N.V. (NASDAQ: ATAI) (“atai”), a clinical-stage
biopharmaceutical company aiming to transform the treatment of
mental health disorders, today announced it has initiated a
clinical study with Massachusetts General Hospital (MGH).
The study will utilize a neuroimaging method to identify
neuroplasticity biomarkers in patients with treatment-resistant
depression (TRD) undergoing intravenous (IV) ketamine treatment.
The main objective of this study will be to develop a novel method
to detect neuroplasticity through magnetic resonance imaging (MRI)
scans, electroencephalogram (EEG) collection and clinical
assessments. The study will identify changes in the brain at
baseline, 24-48 hours post-treatment, and 2 weeks after ketamine
administration. The availability of a validated protocol to measure
structural plasticity at the neuronal level in the human brain
would be a great advancement to the field of neuroplasticity
research and may represent a potential tool for drug developers,
researchers, and providers as an early biomarker of treatment
response and efficacy.
“The study results will help guide atai’s efforts to discover
personalized mental health treatments. Novel imaging biomarkers
during ketamine treatment will enable a deeper understanding of the
therapeutic mechanisms of action (MoA) and the pathophysiology of
TRD. This knowledge can potentially help improve patient outcomes
by informing if and how patients are responding to treatment and
eventually which patients will most benefit from treatment,”
commented atai’s Chief Medical Officer, Rolando Gutiérrez-Esteinou,
MD. “The highly experienced team and technological resources at MGH
will be invaluable in this endeavor.”
Nearly half of the $350 billion spent every year in the U.S. on
mental healthcare is attributable to treatment-resistant patients:
those who do not experience relief from their symptoms despite
multiple treatments. Treatment resistance reflects both the
limitations of our currently available treatments, as well as the
likelihood that these patients’ brains are less capable of change
in ways that improve mental health.
MGH is Harvard Medical School’s largest teaching hospital. Their
Intravenous Ketamine Clinic for Depression offers access to
ketamine treatment for severe and refractory depression. And these
new brain imaging technologies available at MGH through the support
of this study will allow scientists advanced neuroimaging tools and
methods to see the neuroplastic effects of fast-acting drugs like
ketamine.
Dr. Cristina Cusin, Associate Professor in Psychiatry at Harvard
Medical School, Director of the MGH Ketamine Clinic and
Psychiatrist at the Depression Clinical and Research Program, and
Dr. Susie Huang, Associate Professor of Radiology at Harvard
Medical School and Attending Radiologist in the Division of
Neuroradiology and Athinoula A. Martinos Center for Biomedical
Imaging in the Department of Radiology at the Massachusetts General
Hospital, will serve as co-investigators for the study.
Dr. Cusin said of the collaboration, “We are committed to
providing excellent care to patients in need. A critical piece of
this is conducting ground-breaking research. We look forward to
embarking on this clinical study to help develop new tools to
understand the biological changes occurring in depression, which,
in turn, may lead to better and faster diagnosis, more personalized
treatments and better outcomes.”
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
About Massachusetts General Hospital
Massachusetts General Hospital, founded in 1811, is the original
and largest teaching hospital of Harvard Medical School. The Mass
General Research Institute conducts the largest hospital-based
research program in the nation, with annual research operations of
more than $1 billion and comprises more than 9,500 researchers
working across more than 30 institutes, centers and departments. In
July 2022, Mass General was named #8 in the U.S. News & World
Report list of "America’s Best Hospitals." MGH is a founding member
of the Mass General Brigham healthcare system.
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,”
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statements relating to, among other things: statements regarding
the trials and future activities thereunder, the potential trial
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
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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
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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. These forward-looking statements
are subject to a number of risks, uncertainties, and assumptions
that could cause actual results to differ materially from those
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 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; 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
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that any of our product candidates will receive regulatory
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third parties may claim that we are infringing, misappropriating or
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of which would be uncertain and may prevent or delay our
development and commercialization efforts; 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. These and other important factors described in the section
titled “Risk Factors” in our Annual Report on Form 10-K for the
fiscal year ended December 31, 2021 filed with the Securities and
Exchange Commission (“SEC”), as further updated in our Quarterly
Reports on Form 10-Q and subsequent filings with the SEC, from time
to time, may cause our actual results, performance, or achievements
to differ materially and adversely from those expressed or implied
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Contact Information
Investor Contact:Stephen BardinChief Financial
OfficerIR@atai.life
Media Contact: Allan Malievsky Senior Director, External Affairs
PR@atai.life
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