Clearmind Medicine Announces Clinical Supply Agreement for its Upcoming Clinical Trial
May 02 2023 - 8:30AM
Clearmind Medicine Inc. (NASDAQ: CMND) (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 an
agreement with IMP Clinical Supply Services (“IMP”).
IMP will be responsible for the global clinical
supply chain of Clearmind’s proprietary drug candidate CMND-100
from manufacture to the various clinical sites. IMP is known for
its comprehensive, tailor-made clinical supply services that
address all study requirements. The array of services to be
performed are fully compliant with GMP, GCP, and GDP standards.
Clinical drug supply is a critical factor for trial success so
collaboration with best-in-class clinical drug supply vendor
forestalls the possibility of it being a bottleneck to successful
drug delivery. Moreover, it can also deliver enormous benefits,
including better investigator and patient experiences as well as
cost savings in clinical drug supply.
The company's clinical trial is expected to
commence in Q2 2023 in the United States and in Israel.
The primary end point of the 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 Alcohol Use
Disorder ("AUD").
The secondary end point is to preliminarily
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.
Almost 29 million people over 18 struggled with
alcohol use in the US alone in 2020, according to the National
Survey On Drug Use And Health. The condition is most severe among
the young: in the 18-25 age group, 15.6 percent (or 5.2 million
people) had AUD compared to 10.3 percent (or 22.4 million people)
among those over 25.
According to DelveInsight, the AUD treatment
market size in the US, Italy, Spain, UK, Germany, France and Japan
was $564 million in 2021, which is further expected to increase by
8.8% until 2032.
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
incorporated by reference into this press release. Clearmind is not
responsible for the contents of third-party websites.
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