ETHICS
APPROVAL FOR LANDMARK WORLD FIRST PHASE 2 CLINICAL TRIAL OF
TAKE-HOME LSD-MICRODOSING FOR MAJOR DEPRESSIVE DISORDER
-
Ethics
approval received for take-home LSD-Microdosing clinical trial in
depressed patients
-
Clinical
trial has been approved by the Clinical Trials Registry
-
One of two
approved take home Phase 2 LSD-Microdosing Clinical Trials running
in 2023
Vancouver,
British Columbia – May 23, 2023 - InvestorsHub NewsWire
- MindBio Therapeutics
Corp. (CSE: MBIO; Frankfurt: WF6), (the "Company"
or "MindBio")
is pleased to announce that ethics approval has been received for a
world's first Phase 2a take home LSD-Microdosing clinical trial in
patients with Major Depressive Disorder. The trial has also been approved by the
Clinical Trials Registry.
Depressive disorders are a leading cause of
"years lived with disability" globally and there is a clear need
for the development of new, alternative antidepressant
therapies.
In this open-label trial in 20
patients with major depressive disorder (MDD) the tolerability and
feasibility of an 8 week regimen of LSD-Microdosing will be
tested.
The results will inform a
continuation trial, a much larger Phase 2b randomized triple-dummy
active placebo controlled trial in patients with Major
Depressive Disorder.
Major depressive disorder (MDD)
is the leading cause of global disability, with over 260 million
people affected. In Aotearoa/New Zealand, the jurisdiction of this
study, approximately 6% of persons experience a depressive episode
each year.
In the US, the Centers for
Disease Control and Prevention (CDC) predicts that about 16 million
adults in the US will experience depression each
year.
Despite this prevalence,
current medical therapies are limited by slow onset, variable
tolerability, with partial or total lack of efficacy in
approximately one third of patients1.
Surveys have shown that while people who take antidepressants feel
they are helpful for mood, many report problems with drug
withdrawal (74%), sexual dysfunction (72%), weight gain (65%), and
emotional numbing (65%), all of which negatively impact quality of
life2.
With the compounding effects of
high depressive disorder prevalence and low efficacy of
antidepressant therapies there is a clear need for the development
of new, alternative therapies with better efficacy and
tolerability. New effective treatments would provide great benefit
by reducing the health and economic burden of depression for
patients, their families and the community at large.
In 2022, MindBio's Phase 1
take-home LSD-Microdosing clinical trial in 80 healthy participants
yielded positive topline results. The randomized, double blind and placebo
controlled clinical trial found on dose days, participants in the
LSD-Microdosing group experienced increases in:
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Happiness
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Social connectivity
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Creativity
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Wellness
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Energy
Chief Executive Officer of
MindBio Therapeutics, Justin Hanka said "We are pleased to be
advancing our microdosing treatments to Phase 2 clinical
trials.
Psychedelic microdosing
proposes to be a globally scalable solution to treating mental
health conditions and we are excited by the data we are seeing and
the potential future commercialization opportunities for these
medicines."
Receive our latest updates
here:
https://www.mindbiotherapeutics.com/get-updates
Follow MindBio
on LinkedIn: https://www.linkedin.com/company/mindbio-therapeutics/?viewAsMember=true
Follow CEO
Justin Hanka on LinkedIn:
https://www.linkedin.com/in/justinhanka/
For
further information, please contact:
Justin
Hanka, Chief Executive Officer
61
433140886
justin@mindbiotherapeutics.com
References:
-
Warden, D., Rush, A. J., Trivedi, M. H., Fava, M., &
Wisniewski, S. R. (2007). The STAR*D Project results: a
comprehensive review of findings. Curr Psychiatry Rep, 9(6), 449-459. http://www.ncbi.nlm.nih.gov/pubmed/18221624
-
Cartwright, C., Gibson, K., Read, J., Cowan, O., & Dehar, T.
(2016). Long-term antidepressant use: patient perspectives of
benefits and adverse effects. Patient Prefer Adherence, 10, 1401-1407. https://doi.org/10.2147/ppa.S110632
About MindBio
Therapeutics
MindBio is a biotech/biopharma
company focused on creating novel and emerging treatments for
mental health conditions and is conducting world first take-home
LSD-Microdosing human clinical trials. MindBio is a leader in microdosing of
psychedelic medicines and is advancing its drug and technology
protocols through clinical trials. MindBio has developed a
multi-disciplinary platform for developing treatments and is
involved in psychedelic medicine development and digital
therapeutics, has completed Phase 1 clinical trials microdosing
Lysergic Acid Diethylamide (LSD) in 80 patients, has a Phase 2
clinical trial in development microdosing LSD in patients with
Major Depressive Disorder and a Phase 2 clinical trial in
development microdosing LSD in late stage cancer patients
experiencing existential distress. MindBio invests in research that
forms the basis for developing novel and clinically proven
treatments including digital technologies and interventions to
treat debilitating health conditions such as depression, anxiety
and other related mental health conditions.
Cautionary Note
Concerning Forward-Looking Statements:
The press release contains
"forward-looking statements" within the meaning of applicable
securities laws. Forward-looking statements can be identified by
words such as: "anticipate," "intend," "plan," "budget," "believe,"
"project," "estimate," "expect," "scheduled," "forecast,"
"strategy," "future," "likely," "may," "to be," "could," "would,"
"should," "will" and similar references to future periods or the
negative or comparable terminology, as well as terms usually used
in the future and conditional. Forward-looking statements are based
on assumptions as of the date they are provided. However, there can
be no assurance that such assumptions will reflect the actual
outcome of such items or factors.
Additionally, there are known
and unknown risk factors that could cause the Company's actual
results and financial conditions to differ materially from those
indicated in the forward-looking statements. Therefore, you should
not rely on any of these forward-looking statements. Important risk
factors that could cause actual results and financial conditions to
differ materially from those indicated in the forward-looking
statements, include among others: general economic, market and
business conditions in Canada and Australia; market volatility;
unforeseen delays in timelines for any of the transactions or
events described in this press release. All forward-looking information is
qualified in its entirety by this cautionary statement.
The Company disclaims any
obligation to revise or update any such forward-looking statement
or to publicly announce the result of any revisions to any of the
forward-looking information contained herein to reflect future
results, events or developments, except as required by
law.
Neither the Canadian Securities
Exchange nor its Regulation Service Provider (as that term is
defined in the policies of the Canadian Securities Exchange)
accepts responsibility for the adequacy or accuracy of this
release.
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