Clearmind Medicine Announces IRB Approval to Conduct Clinical Trial on Alcohol Use Disorder
May 12 2023 - 9:00AM
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, has received Ethics
Committee approval for its CM-CMND-001 Phase I/II clinical trial of
its MEAI-based CMND-100 compound for the treatment of alcohol use
disorder ("AUD") at Israel’s IMCA center.
CM-CMND-001 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 this study, subject to signing an agreement with
local sites.
The primary end point of the clinical trial is to find the
tolerable dose and characterize the safety and pharmacokinetics/
pharmacodynamics (PK/PD) of single and repeated doses of CMND-100
in healthy subjects and those with AUD. The secondary end point is
to evaluate the efficacy of CMND-100 in reduction of drinking
patterns and craving, in individuals with moderate-to-severe AUD.
Oral capsules will be administered once daily, for ten consecutive
days. The patients will report their drinking patterns and craving
for alcohol (and cigarettes) during the clinical trial period.
“Ethics Committee approval of the study marks a key step forward
in beginning the first-in-human clinical trial of CMND-100," said
Clearmind’s Chief Executive Officer, Dr. Adi Zuloff-Shani.
“According to Research Nester, the alcohol treatment market is
estimated to be USD 35 billion per year market in the U.S. alone,
where the estimated number of people diagnosed with AUD total
approximately 35 million people each year. Despite a significant
addressable market and the fact AUD is a leading cause of death,
current therapies often fall short due to limited efficacy, relapse
rates, side effects and other factors. CMND-100 was shown to cause
a significant and immediate reduction of alcohol cravings and
consumption in pre-clinical studies with a high safety profile. As
a result, we believe that CMND-001 holds tremendous potential as an
alternative to current approaches. Moreover, CMND-100 is intended
as a once-a-day oral capsule that can be taken from the privacy of
one’s home. With CMND-100, we aim to revolutionize AUD treatment
and improve patients’ compliance to therapy compared to other
marketed pharmacotherapies”.
The Ethics Committee (which is the European and Israeli
equivalent of the Institutional Review Board (IRB)), of the IMCA
center, operating under the Declaration of Helsinki regulations and
other international conventions concerning medical experiments on
humans, is designated to authorize, review and monitor medical
research and trials involving human subjects. The committee reviews
research protocols and related materials (such as informed consent
documents and investigator brochures) to ensure protection of the
rights and welfare of the participants.
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
fourteen 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 Relationsinvest@clearmindmedicine.comTelephone: (604)
260-1566
General
InquiriesInfo@Clearmindmedicine.comwww.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 the services to be
performed by IMP and the benefit to the company therefrom, the
timing of clinical trials, and the market size for AUD treatment
and expected growth. 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
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