Clearmind Medicine Completed Type A Meeting with the FDA
10 Gennaio 2024 - 1:18PM
Clearmind Medicine Inc. (Nasdaq, CSE: CMND), (FSE: CWY)
(“Clearmind” or the "company"), a biotech company focused on
discovery and development of novel psychedelic-derived therapeutics
to solve major under-treated health problems, today announced it
has completed a Type A meeting with the U.S. Food and Drug
Administration (FDA) to discuss the Company’s clinical trial
of its proprietary MEAI-based, CMND-100 compound, for the treatment
of Alcohol Use Disorder treatment (AUD) using its novel
psychedelic- based therapy.
"We're pleased to report we recently met with the FDA to align
on the content of our IND resubmission for CMND-100," said Dr. Adi
Zuloff-Shani, CEO of Clearmind Medicine. “The meeting was
informative and productive, and we’re eager to advance the U.S.
regulatory process and potentially bring a new hope for millions
suffering from AUD by providing an innovative approach to overcome
the challenges associated with the current available treatments to
date."
The active ingredient in CMND-100 is MEAI
(5-methoxy-2-aminoindane), a novel psychoactive molecule that has
been reported to reduce the desire to consume alcoholic beverages
while exerting a euphoric alcohol-like experience. MEAI was found
to interact with the serotonergic receptors 5-HT1a, 5-HT2a and
5-HT2b. The serotonergic system is considered to play a key role in
the regulation of alcohol intake, reward, preference, and
dependence. MEAI was also found to interact with the
alpha-2-adrenergic receptors α2A, α2B and α2C and the plasma
membrane monoamine transporters for dopamine (DAT), norepinephrine
(NET) and serotonin (SERT); these are believed to participate in
mediating alcohol drinking behavior, and therefore could constitute
important molecular targets for interventions that target drugs of
abuse such as alcohol.
About Clearmind Medicine Inc.
Clearmind is a psychedelic pharmaceutical biotech company
focused on the discovery and development of novel
psychedelic-derived therapeutics to solve widespread and
underserved health problems, including alcohol use disorder. Its
primary objective is to research and develop psychedelic-based
compounds and attempt to commercialize them as regulated medicines,
foods or supplements.
The Company’s intellectual portfolio currently consists of
fifteen patent families. The Company intends to seek additional
patents for its compounds whenever warranted and will remain
opportunistic regarding the acquisition of additional intellectual
property to build its portfolio.
Shares of Clearmind are listed for trading on Nasdaq and the
Canadian Securities Exchange under the symbol "CMND" and the
Frankfurt Stock Exchange under the symbol “CWY.”
For further information
visit: https://www.clearmindmedicine.com or contact:
Investor Relations invest@clearmindmedicine.com Telephone: (604)
260-1566 US: CMND@crescendo-ir.com
General Inquiries Info@Clearmindmedicine.com
www.Clearmindmedicine.com
Forward-Looking Statements:
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act and
other securities laws. Words such as “expects,” “anticipates,”
“intends,” “plans,” “believes,” “seeks,” “estimates” and similar
expressions or variations of such words are intended to identify
forward-looking statements. For example, the Company is using
forward-looking statements when it discusses how CMND-100 has the
potential to offer a new hope for millions suffering from Alcohol
Use Disorder, providing an innovative approach to overcome the
challenges associated with traditional treatments and the advance
the U.S. regulatory process. Forward-looking statements are not
historical facts, and are based upon management’s current
expectations, beliefs and projections, many of which, by their
nature, are inherently uncertain. Such expectations, beliefs and
projections are expressed in good faith. However, there can be no
assurance that management’s expectations, beliefs and projections
will be achieved, and actual results may differ materially from
what is expressed in or indicated by the forward-looking
statements. Forward-looking statements are subject to risks and
uncertainties that could cause actual performance or results to
differ materially from those expressed in the forward-looking
statements. For a more detailed description of the risks and
uncertainties affecting the Company, reference is made to the
Company’s reports filed from time to time with the Securities and
Exchange Commission (“SEC”), including, but not limited to, the
risks detailed in the Company’s annual report on Form 20-F filed
with the SEC on February 6, 2023. Forward-looking statements speak
only as of the date the statements are made. The Company assumes no
obligation to update forward-looking statements to reflect actual
results, subsequent events or circumstances, changes in assumptions
or changes in other factors affecting forward-looking information
except to the extent required by applicable securities laws. If the
Company does update one or more forward-looking statements, no
inference should be drawn that the Company will make additional
updates with respect thereto or with respect to other
forward-looking statements. References and links to websites have
been provided as a convenience, and the information contained on
such websites is not incorporated by reference into this press
release. Clearmind is not responsible for the contents of
third-party websites.
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