BASEL, Switzerland,
May 20, 2021 /PRNewswire/
-- MindMed (Nasdaq: MNMD) (NEO: MMED) (DE: MMQ), a leading
clinical stage psychedelic medicine company, announced today the
approval by the local Swiss ethics committee of the first clinical
trial evaluating the acute effects of different doses of mescaline
and the role of the serotonin 5-HT2A receptor in mescaline-induced
altered states of consciousness (MDR-Study). The study will be
conducted at the University Hospital Basel Liechti Lab, in
Basel, Switzerland, and is planned
to start this month.
Mescaline is a classic serotonergic hallucinogen, similar to LSD
psilocybin, with a long, non-regulated history of spiritual use.
However, modern regulated studies using validated psychometric
tools and directly comparing different doses of mescaline including
placebo are missing. We believe this phase 1 study will provide
such data and an important basis for further research in the
therapeutic potential of mescaline.
Dr. Matthias Liechti, PhD &
M.D., professor for clinical pharmacology and internal medicine at
the University of Basel stated,
"Mescaline is an archetypical psychedelic with surprisingly little
contemporary scientific information on its pharmacology and effects
in humans. This study will, we believe, provide the first modern
research data on mescaline regarding dosing and mechanism of action
in humans."
The serotonin 2A (5-HT2A) receptor is thought to primarily
mediate acute alterations of consciousness induced by LSD and
psilocybin. Mescaline also binds to the 5-HT2A receptor with lower
potency and higher activity compared to LSD. The present study will
also explore the mechanism of action of mescaline in humans and
specifically whether the acute psychoactive effects of mescaline in
humans are mediated by 5-HT2A receptors.
Compared with LSD and psilocybin, relatively high doses of
300-800 mg mescaline are needed to produce a prototypical
hallucinogenic experience. Whether there are differences in the
effects of mescaline compared with those of LSD or psilocybin will
also be determined in additional studies.
The present study will primarily help to characterize the
subjective effects of different doses of mescaline using modern
psychometric outcome measures. It will also explore the role of the
5-HT2A receptor in mescaline-induced altered states of
consciousness using the 5-HT2A receptor blocker ketanserin prior to
the administration of a high dose of mescaline.
The study will use a double-blind, placebo-controlled,
cross-over design with six different dosing conditions. The
treatment order will be randomized and counter-balanced.
Dr. Miri Halperin Wernli,
President of MindMed, added, "At present there are no modern
studies that we are aware of using validated psychometric outcome
measures that directly compare different doses of mescaline. With
our rigorous clinical trial, we aim to characterize the subjective
effects of different doses of mescaline and provide a description
of the acute mescaline effects to help clarify the involvement of
the 5-HT2A receptor in mescaline-induced altered states of
consciousness in healthy people. We believe the drug will have a
powerful effect on enhancing the communication between different
parts of the brain in unique ways that are otherwise inaccessible
to the conscious mind. As we move forward, further studies on
patient populations will be targeted to help us distinguish the
relationship between the drug-induced experience and its
integration into the psychotherapeutic process. The hope is that
this will then allow a better understanding of the behavioral
changes and the unique effect of these powerful drugs on
neuroplasticity."
About MindMed
MindMed is a clinical-stage psychedelic
medicine biotech company that discovers, develops and deploys
psychedelic inspired medicines and therapies to address addiction
and mental illness. The company is assembling a compelling drug
development pipeline of innovative treatments based on psychedelic
substances including psilocybin, LSD, MDMA, DMT, mescaline and an
Ibogaine derivative, 18-MC. The MindMed executive team brings
extensive biopharmaceutical experience to MindMed's approach to
developing the next generation of psychedelic inspired medicines
and therapies.
MindMed trades on the NASDAQ under the symbol MNMD and on the
Canadian NEO exchange under the symbol MMED. MindMed is also traded
in Germany under the symbol
MMQ.
Forward-Looking Statements
Certain statements in this
news release related to the Company constitute "forward-looking
information" within the meaning of applicable securities laws and
are prospective in nature. Forward-looking information is not based
on historical facts, but rather on current expectations and
projections about future events and are therefore subject to risks
and uncertainties which could cause actual results to differ
materially from the future results expressed or implied by the
forward-looking statements. These statements generally can be
identified by the use of forward-looking words such as "will",
"may", "should", "could", "intend", "estimate", "plan",
"anticipate", "expect", "believe", "potential" or "continue", or
the negative thereof or similar variations. Forward-looking
information in this news release includes statements regarding the
timing of the start of the mescaline study; whether the study will
provide the basis for further research in the therapeutic potential
of mescaline, including whether that will include sufficient data
on mescaline dosing and its mechanism of action in humans; the
study's success in exploring the role of the 5-HT2A receptor in
mescaline-induced altered states of consciousness; the study's
ability to characterize the subjective effects of different doses
of mescaline and provide a description of the acute mescaline
effects; the study's ability to help clarify the involvement of the
5-HT2A receptor in mescaline-induced altered states of
consciousness in healthy people; the Company's belief that the drug
will have an effect on enhancing the communication between
different parts of the brain in unique ways that are otherwise
inaccessible to the conscious mind; whether further studies on
patient populations will occur; and whether the study will allow a
better understanding of the behavioral changes and the unique
effect of mescaline on neuroplasticity. Although the Company
believes that the expectations reflected in such forward-looking
information are reasonable, such information involves risks and
uncertainties, and undue reliance should not be placed on such
information, as unknown or unpredictable factors could have
material adverse effects on future results, performance or
achievements of the Company. There are numerous risks and
uncertainties that could cause actual results and the Company's
plans and objectives to differ materially from those expressed in
the forward-looking information, including history of negative cash
flows; limited operating history; incurrence of future losses;
availability of additional capital; lack of product revenue;
compliance with laws and regulations; difficulty associated with
research and development; risks associated with clinical trials or
studies; heightened regulatory scrutiny; early stage product
development; clinical trial risks; regulatory approval processes;
novelty of the psychedelic inspired medicines industry; as well as
those risk factors discussed or referred to herein and the risks
described under the headings "Risk Factors" in the Company's
filings with the securities regulatory authorities in all provinces
and territories of Canada which
are available under the Company's profile on SEDAR at www.sedar.com
and with the U.S. Securities and Exchange Commission on EDGAR
at www.sec.gov. Should one or more of these risks or
uncertainties materialize, or should assumptions underlying the
forward-looking information prove incorrect, actual results and
future events could differ materially from those anticipated in
such information. Although the Company has attempted to identify
important risks, uncertainties and factors that could cause actual
results to differ materially, there may be others that cause
results not to be as anticipated, estimated or intended. These and
all subsequent written and oral forward-looking information are
based on estimates and opinions of management on the dates they are
made and are expressly qualified in their entirety by this notice.
Except as required by law, the Company does not intend and does not
assume any obligation to update this forward-looking
information.
Media Contact: mindmed@150bond.com
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SOURCE Mind Medicine (MindMed) Inc.