Clearmind Medicine Announces First US Site for its Phase I/IIa Clinical Trial Evaluating CMND-100 in Patients with Alcohol Use Disorder
May 22 2023 - 8:30AM
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 the
selection of its first U.S. site for the company’s Phase I/IIa
clinical trial of its proprietary MEAI-based CMND-100 compound for
the treatment of alcohol use disorder ("AUD"). Yale School of
Medicine’s Department of Psychiatry is the first US-based clinical
site to join the company's first-in-human (FIH) trial.
The site will be led by Anahita Bassir Nia, MD, a specialist in
substance abuse, including alcohol abuse. She joined the Yale
School of Medicine in 2018 as an Assistant Professor of Psychiatry,
after completing her psychiatry residency at Mount Sinai Beth
Israel and her addiction psychiatry fellowship at Mount Sinai
West’s Icahn School of Medicine in New York.
“We are honored to have Yale School of Medicine’s Department of
Psychiatry as part of our clinical trial," said Clearmind’s Chief
Executive Officer Dr. Adi Zuloff-Shani. “We see this collaboration
with a global pioneer in psychedelics research, as further
validation of our innovative drug candidate for potential treatment
for alcohol use disorder.”
Clearmind recently announced it had been granted approval by the
Ethics Committee (equivalent of an institutional review board) of
Israel’s IMCA center for the Phase I/IIa clinical trial of
CMND-100. The CM-CMND-001 clinical trial is a multinational,
multi-center, Phase I/II single- and multiple-dose tolerability,
safety and pharmacokinetic study in healthy volunteers and AUD
subjects.
“We believe that CMND-100 has the potential to be a game-changer
in treating addictions and mental health concerns, as successfully
demonstrated in previous pre-clinical studies,” added Dr.
Zuloff-Shani. “With an extensive IP portfolio and an award-winning
advisory board of renowned psychiatrists and researchers from
around the world, we’re confident in our unique treatment model.
CMND-100 is expected to provide immediate therapeutic benefit, as a
self-administered and non-addictive prescription pill that is not
dependent on expensive therapies."
In the clinical trial, 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.
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 in 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.
Dr. Zuloff-Shani said that Dr. Bassir Nia is ideal for the task
because “her research focuses on addiction and mental health
disorders, and she is particularly interested in the biological
effects of acute and chronic stress on-developing substance use
disorders.”
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 on Nasdaq and the Canadian
Securities Exchange under the symbol "CMND" and the Frankfurt Stock
Exchange under the symbol “CWY.”
For further information
visit: www.clearmindmedicine.com or contact:
Investor Relations
invest@clearmindmedicine.com
Telephone: (604) 260-1566
US: CMND@crescendo-ir.com
General Inquiries
Info@Clearmindmedicine.com
www.Clearmindmedicine.com
FORWARD-LOOKING STATEMENTS:
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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
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forward-looking statements. For example, the Company is using
forward-looking statements when it discusses its clinical trial
collaborations, and the potential therapeutic benefit of its
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Forward-looking statements are subject to risks and uncertainties
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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
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