Clearmind Medicine Announces IRB Approval for FDA First-In-Human Clinical Trial of CMND-100 at Second Clinical Site
10 October 2024 - 11:07PM
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 from one of
its clinical sites in the U.S. for part A of its Phase I/IIa
clinical trial in the United States for treating patients suffering
from alcohol use disorder (AUD).
The multinational, multi-center trial will assess the safety,
tolerability, and pharmacokinetics of Clearmind’s innovative
MEAI-based (5-methoxy-2-aminoindane) treatment, CMND-100. In
addition to Johns Hopkins University, Maryland, USA, the trial will
also take place at Yale School of Medicine, Connecticut, USA and
IMCA Center in Ramat Gan, Israel. The Company has already secured
FDA approval for its Investigational New Drug (IND) application to
conduct the trial in the U.S., as well as approval from the Israeli
Ministry of Health. IMCA’s IRB approval has also been granted.
Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine, commented: “IRB
approval marks another key milestone towards the launch of our
Phase I/IIa clinical trial for alcohol use disorder. Together with
the IMCA approval, this becomes our second approved site, bringing
us closer to offering hope to those suffering from the devastating
effects of alcohol addiction. Alcohol abuse is a major global
health issue and one of the leading preventable causes of death,
particularly in the U.S., where AUD is the most common substance
use disorder among people aged 12 and older1.”
The primary endpoint of the trial, titled A Phase I/II Single
and Multiple Dose Tolerability, Safety and Pharmacokinetic Study of
CMND-100 in Healthy Volunteers and Subjects with Alcohol Use
Disorder (AUD), is to determine the tolerable dose and evaluate the
safety, pharmacokinetics, and pharmacodynamics of CMND-100. More
information is available at clinicaltrials.gov.
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 potential to bring
hope to those suffering from the devastating addiction to alcohol.
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
https://www.cdc.gov/alcohol/facts-stats/index.html |
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