Full Press Release Details
Israeli Based Biotech Company Clearmind Completes IND-Enabling
Studies for CMND-100
The MEAI-based proprietary compound is aimed at treating Alcohol
Tel Aviv, Israel / Vancouver, Canada, December 13, 2022 -- 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 IND-enabling studies on its CMND-100 (MEAI- based) compound aimed at treating alcohol use disorder (AUD), in preparation
for its first in-human clinical trial.
An Investigational New Drug (IND) application is required by the U.S.
Food and Drug Administration (FDA) before commencing clinical studies in humans may initiate. The company is in the process of preparing
the IND for its submission to the FDA and the Israeli Ministry of Health.
As part of this year-long process, the company preformed pharmacology,
pharmacokinetics, and toxicology assessments on the MEAI-based compound.
Previous pre-clinical studies using MEAI demonstrated a high safety
profile and indications of a significant dose-dependent effect reducing alcohol consumption in treated animals.
"Upon completion of the IND-enabling studies for our novel drug
candidate to treat AUD, we are one step closer to launching our first human clinical trial," said Dr. Adi Zuloff-Shani, Clearmind's
CEO. "We intend to submit our IND request in early 2023 and to start Phase I/IIa clinical trials in the U.S. and Israel."
"I am very excited about reaching the final stages of our non-clinical
program, within timelines and with promising results that will hopefully enable us to initiate our clinical trial soon. This is a very
important milestone in the drug development pipeline, and I am very enthusiastic about the near future of MEAI," said R&D Director,
CMND-100, which is Clearmind's lead compound, is a novel psychedelic-derived
drug candidate, exhibiting compelling evidence that suggests a significant reduction of desire to consume alcoholic beverages- addressing
a global unmet need.
AUD is a chronic relapsing brain disorder characterized by impaired
ability to control alcohol use despite negative social, occupational, and health consequences. One of the world's gravest health
problems, AUD costs the United States alone an estimated $250 billion each year, and is the third leading preventable cause of death in
CMND-100 is assumed to suppress the decision to consume more alcohol
by potentially innervating neural pathways associated with the 5-HT1A receptor that lead to "sensible behavior."
Clearmind's intellectual property portfolio includes issued patents
in the United States, Europe, China and India covering, among other, the use of CMND-100 in treating AUD.
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 seven
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 under the symbol
"CMND", the Canadian Securities Exchange under the symbol "CMND" and the Frankfurt Stock Exchange under the symbol
For further information, please contact:
Email: invest@clearmindmedicine.com
Telephone: (604) 260-1566
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 initiating human clinical trials, that the company is in the process of preparing an IND
for its submission to the FDA and the Israeli Ministry of Health, and the progress of its drug development pipeline. 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 final
prospectus (registration No. 333-265900) filed with the SEC on November 16, 2022. 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
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