MINDBIO
THERAPEUTICS BEGINS DOSING MB22001 IN
PHASE 2 CLINICAL TRIAL IN WORLD FIRST TAKE-HOME
MICRODOSING STUDY IN PATIENTS WITH DEPRESSION
-
World-first take-home
approvals
-
The first doses of
MB22001 have been administered in an 8 week treatment
protocol
Vancouver, British
Columbia, Canada -- August 24, 2023 -- InvestorsHub NewsWire
-- MindBio Therapeutics Corp.
(CSE:
MBIO; Frankfurt: WF6), (the
"Company" or "MindBio"),
is pleased to announce the first doses of
MB22001 have been administered to patients in this landmark
microdosing study in depressed
patients. This trial is a
world first and remains the only clinical trials in the world to be
approved for take-home use of LSD.
MB22001 is MindBio's proprietary titratable
form of Lysergic Acid Diethylamide (LSD) designed for safe and
effective take home microdosing in patients suffering from Major
Depressive Disorder.
The microdose of this psychedelic medicine is
sub-hallucinogenic and is taken every third day for 8 weeks in this
open label Phase 2a clinical trial in 20
participants. This Phase 2a
clinical trial is designed to test the feasibility, tolerability
and effectiveness of MB22001 microdosing in patients with Major
Depressive Disorder.
The trial will form the basis for continuing
a much larger Phase 2b randomized triple dummy controlled trial in
depressed patients.
MindBio's clinical trials of MB22001 have
already yielded positive top line data in healthy
individuals. The results of
MindBio's Phase 1 randomized controlled trial in 80 healthy
participants produced surprising sleep data from over 3200 days of
sleep recording an average 24 minutes of additional total sleep
time and 8 minutes of additional REM sleep the day after dose
days. The landmark
trial in healthy individuals also produced statistically
significant enhancements in subjective feelings of "wellness",
"creativity", "happiness", "social connectivity" and "energy" on
dose days. Participants in the MB22001 microdosing group also
reported statistically significant feelings of being less "angry"
and less "irritable".
MindBio is working towards the
commercialization of microdosing treatments with a package of
proprietary solutions for safe and effective at home use of
psychedelics. MindBio remains
the only organization in the world approved for take-home use of
LSD-Microdosing in clinical trials.
The take home approvals are vital for testing
the ecological validity of MindBio's proprietary solutions as the
Company progresses its commercialization strategy for global
regulatory approvals.
Chief Executive Officer of MindBio said "We
are delighted to begin this important clinical trial in patients
suffering from the debilitating effects of depression and we hope
that this medicine and unique treatment protocol will be effective
at mitigating those symptoms and provide a superior treatment
outcome to the current available treatment options for
depression".
MindBio's investment thesis, using
microdosing, centers on the creation of a unique treatment model
that is globally scalable, safe, accessible, and affordable, aiming
to address the existing challenges in mental health care and also
caters for the diversity of medical regulatory regimes around the
world.
We invite you to join us in support of
creating a brighter future for mental health.
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
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
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