Clearmind Medicine Receives Approval to Commence its Phase I/IIa Clinical Trial of CMND-100 for Alcohol Use Disorder
23 Febbraio 2024 - 1:06PM
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, is pleased to
announce it has received approval from the Ministry of Health of
Israel to commence its phase I/IIa clinical trial for alcohol use
disorder (AUD) patients using the company's proprietary MEAI-based
(5-methoxy-2-aminoindane) CMND-100 oral capsule.
"We are thrilled to receive approval to commence our phase I/IIa
clinical trial for our lead drug candidate, CMND-100, which has
been shown to be safe and effective in preclinical studies. This is
the most important milestone for the company to date and marks our
transition to a clinical- stage pharmaceutical company. The
Clearmind team has been working tirelessly on the research and
development of a novel treatment to the global epidemic of
alcoholism. We are eager to continue our work with patients in need
of help,” said Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine.
“Our non-hallucinogenic, psychedelic solution could be the answer
to the tremendous global need for groundbreaking, dedicated and
effective treatments for addictions."
The clinical trial is a multinational, multi-center, single and
multiple dose tolerability, safety and pharmacokinetic study of
CMND-100 in healthy volunteers and AUD subjects. The Israeli study
will be led by Prof. Mark Weiser, M.D., head of the Psychiatric
Division at the Sheba Medical Center in the Tel Aviv suburb of
Ramat Gan.
The company intends to have two additional sites in the United
States for the phase I/IIa clinical trial, at the Yale School of
Medicine’s Department of Psychiatry and the Johns Hopkins
University School of Medicine.
The primary endpoint of the clinical trial is to find the
tolerable dose and characterize the safety and pharmacokinetics/
pharmacodynamics of single and repeated doses of CMND-100 in
healthy subjects and those with AUD. The secondary endpoint is to
evaluate preliminary efficacy of CMND-100 in reduction of drinking
patterns and cravings in individuals with moderate-to-severe AUD.
Oral capsules will be administered and subjects treated by these
oral capsules will report their drinking patterns and cravings for
alcohol during the clinical trial.
The active ingredient in CMND-100 is MEAI, an innovative,
psychoactive and non-hallucinogenic molecule that has been reported
to reduce the desire to consume alcoholic beverages, while exerting
a slight euphoric alcohol-like experience. MEAI was found to
interact with the serotonergic receptors 5-HT1a and 5-HT2a. 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, as well as the plasma membrane
monoamine transporters for dopamine (DAT), norepinephrine (NET) and
serotonin (SERT). These receptors and transporters are believed to
participate in mediating alcohol drinking behavior and could
constitute important molecular targets for interventions that
target drugs subject to 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 its transition to a
clinical- stage pharmaceutical company and how its
non-hallucinogenic, psychedelic solution could be the answer to the
tremendous global need for groundbreaking, dedicated and effective
treatments for addictions. 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 January 29, 2024. 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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