Clearmind Medicine Receives IRB Approval for its FDA-Regulated Clinical Trial
24 12월 2024 - 8:55PM
Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or
the "Company"), a clinical-stage biotech company focused on
discovery and development of novel psychedelic-derived therapeutics
to solve major under-treated health problems, today announced it
has received Institutional Review Board (IRB) approval for its
Phase I/IIa clinical trial of CMND-100, targeting alcohol use
disorder (AUD).
The trial will be led at Yale School of Medicine’s Department of
Psychiatry by Dr. Anahita Bassir Nia, MD, an expert in psychiatry
and addiction medicine. This milestone marks a significant step
forward in Clearmind’s FDA-regulated clinical program, further
expanding the multi-site trial to evaluate the safety, tolerability
and efficacy of its proprietary investigational drug, CMND-100.
“Receiving the IRB approval from Yale University, takes us one
step closer to commencing our innovation clinical trial with our
proprietary CMND-100, for treating AUD patients,” said Dr. Adi
Zuloff-Shani, CEO of Clearmind Medicine. “Alcohol consumption is
responsible for 2.6 million deaths annually worldwide, accounting
for 4.7% of all global deaths, and excessive alcohol use is a
leading preventable cause of death in the U.S. It remains the most
commonly used substance among individuals aged 12 and older in the
United States, imposing a significant economic burden with billions
spent on healthcare costs. Current treatment options are limited by
high costs, have low efficacy (less than 30%) and low patient
compliance due to side effects1. We believe we have a unique
opportunity to address this critical gap and provide an effective
solution for treating this widespread condition.”
The clinical trial will assess CMND-100’s ability to reduce
alcohol cravings and consumption among individuals with moderate to
severe AUD. The study is designed to gather critical data
supporting the advancement of CMND-100 through the clinical
pipeline.
About Clearmind Medicine Inc.
Clearmind is a clinical-stage 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
nineteen patent families including 29 granted patents. 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 under the
symbol "CMND" and the Frankfurt Stock Exchange under the symbol
“CWY0.”
For further information
visit: https://www.clearmindmedicine.com or contact:
Investor Relationsinvest@clearmindmedicine.com
Telephone: (604) 260-1566US: 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 the timing of the
commencement of its innovation clinical trial with its proprietary
CMND-100, for treating AUD patients and its belief that it has a
unique opportunity to address the critical gaps in AUD treatment
and provide an effective solution for treating AUD. The Company
cannot assure that any patent will issue as a result of a pending
patent application or, if issued, whether it will issue in a form
that will be advantageous to the Company. 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 for the
fiscal year ended October 31, 2023 filed with the SEC.
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.
1 Pharmacotherapy for Adults With Alcohol Use Disorders in
Outpatient Settings A Systematic Review and Meta-analysis, 2014.
Winslow BT, Onysko M, Hebert M. Medications for Alcohol Use
Disorder. Am Fam Physician. 2016 Mar 15;93(6):457-65.
Clearmind Medicine (NASDAQ:CMND)
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Clearmind Medicine (NASDAQ:CMND)
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