atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”) announced today
positive initial results for their Phase 1 clinical trial of
KUR-101. KUR-101 is an oral formulation of deuterated mitragynine,
the major active alkaloid of the kratom plant, under development
for the treatment of opioid use disorder (OUD).
Initial results indicate that KUR-101 is safe and generally
well-tolerated. Results also showed a dose-proportional
pharmacokinetic (PK) profile that was unaffected by food. In the
single ascending oral dose portion of the trial, no severe or
serious adverse events were reported, with most treatment-related
adverse events being mild. Changes in respiratory rate following
treatment with KUR-101 were comparable to that of placebo-treated
patients for the doses tested and comparable across doses.
“Exacerbated by the stresses of the pandemic, according to the
CDC, the U.S. saw an approximate 30% increase in drug overdose
deaths in 2020 and nearly 75% of those deaths involved opioids,”
said Florian Brand, CEO of atai. “There are currently only three
FDA-approved therapeutics for OUD; they produce side effects and
about 75% of patients undergoing OUD therapy experience relapse
within one year of treatment. New alternatives could improve the
treatment landscape of addiction.”
According to Fortune Business Insights, the global OUD market is
projected to grow from $2.68 billion in 2021 to $4.81 billion in
2028. The jump is driven partially by the surge in people suffering
from opioid relapses and overdoses amid the pandemic.
The pharmacological therapies currently approved for OUD,
buprenorphine, methadone, and naltrexone, carry several challenges,
including limited efficacy for many patients, inconvenient
treatment regimens, and access barriers due to inherent risks of
abuse.
Compared with current options, KUR-101 is an atypical opioid
receptor modulator with unique pharmacology that may make it safer
for chronic use. The deuteration of mitragynine improves the PK and
overall safety profile of KUR-101 while reducing dosing
requirements. Topline results, including Part 2 of the trial
comparing a single dose of KUR-101 to a single dose of oxycodone or
placebo, are expected by the end of 2022.
“We’re pleased with the results of our initial Phase 1 findings
of KUR-101,” said Dr. Chad Beyer, CEO of Kures, a subsidiary of
atai Life Sciences leading the KUR-101 program. “These findings
increase our confidence in KUR-101 as a potential treatment for
patients battling addiction, experiencing pain, and debilitating
mental health disorders.”
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 Kures Therapeutics
Kures is a spinout from Columbia University and is developing
KUR-101 for the treatment of OUD and acute pain. KUR-101 is a
deuterated derivative of mitragynine, the major alkaloid in kratom
that is a relatively low-potency mu-opioid receptor, or MOR,
agonist. KUR-101 is a semi-synthetically produced drug substance
designed to improve the safety profile and potential effectiveness
of mitragynine. In results from our preclinical studies carried out
to date, KUR-101 has shown dose-dependent analgesic effects without
inducing significant respiratory depression at therapeutic doses in
animal models.
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 trials by Kures, Inc. and future activities thereunder, the
potential of KUR-101, 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.
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
the completion of such trials, research, or testing, changes to
trial sites and other circumstances; we cannot give any assurance
that any of our product candidates will receive regulatory
approval, which is necessary before they can be commercialized;
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; 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”), our Quarterly Reports on Form 10-Q and
our Current Reports on Form 8-K, as updated by our subsequent
filings with the SEC, may cause our actual results, performance, or
achievements to differ materially and adversely from those
expressed or implied by the forward-looking statements. Any such
forward-looking statements represent management’s estimates as of
the date of this press release. While we may elect to update such
forward-looking statements at some point in the future, we disclaim
any obligation to do so, even if subsequent events cause our views
to change.
Contact InformationInvestor Contact:Stephen
BardinChief Financial OfficerIR@atai.life
Media Contact: Allan Malievsky Senior Director, External Affairs
PR@atai.life
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