Clearmind Medicine received IRB approval for its Phase I/IIa trial of CMND-100 to treat alcohol use disorder.
Quiver AI Summary
Clearmind Medicine Inc., a clinical-stage biotech company focused on psychedelic-derived therapeutics, has announced the receipt of Institutional Review Board approval for its Phase I/IIa clinical trial of CMND-100, aimed at treating alcohol use disorder (AUD). The trial will be conducted at Yale School of Medicine under the guidance of Dr. Anahita Bassir Nia, MD. This represents a significant advance in Clearmind's clinical program, as the trial will assess the safety, tolerability, and efficacy of CMND-100 in reducing alcohol cravings and consumption in individuals with moderate to severe AUD. Dr. Adi Zuloff-Shani, the company's CEO, highlighted the urgent need for effective treatment options, noting the high rates of alcohol-related deaths and the limitations of current therapies. Clearmind holds a robust intellectual portfolio with numerous patents related to its psychedelic compounds.
Potential Positives
- Clearmind Medicine received Institutional Review Board (IRB) approval for its Phase I/IIa clinical trial of CMND-100, a significant milestone in the FDA-regulated clinical program.
- The trial will be conducted at Yale School of Medicine’s Department of Psychiatry, led by an expert in the field, enhancing the credibility and visibility of the study.
- The clinical trial aims to address alcohol use disorder (AUD), a serious global health issue, presenting a unique opportunity for Clearmind to fill a market gap with its proprietary drug.
- The company's extensive intellectual property portfolio, consisting of nineteen patent families and 29 granted patents, supports its potential for innovation and competitiveness in the biotech industry.
Potential Negatives
- The company's Phase I/IIa clinical trial for CMND-100 is still in the early stages, indicating that it has not yet proven the drug's efficacy or safety, which could lead to uncertain future outcomes and possible investor concerns.
- The press release includes extensive caveats about forward-looking statements, highlighting the inherent risks and uncertainties in developing new therapies, which may diminish investor confidence.
- Despite receiving IRB approval, there is no guarantee that subsequent stages of the clinical trials will be approved or successful, potentially impacting the company's future prospects and market performance.
FAQ
What is the focus of Clearmind Medicine Inc.?
Clearmind Medicine Inc. specializes in developing psychedelic-derived therapeutics to address major under-treated health issues, particularly alcohol use disorder (AUD).
What recent approval did Clearmind receive for its clinical trial?
Clearmind received Institutional Review Board (IRB) approval for its Phase I/IIa clinical trial of CMND-100 targeting alcohol use disorder (AUD).
Who is leading the CMND-100 clinical trial?
The clinical trial will be led by Dr. Anahita Bassir Nia at Yale School of Medicine’s Department of Psychiatry.
What are the expected outcomes of the CMND-100 trial?
The trial aims to evaluate CMND-100's safety, tolerability, and efficacy in reducing alcohol cravings and consumption in AUD patients.
How does alcohol impact global health according to Clearmind?
Alcohol consumption causes 2.6 million deaths annually worldwide and is a leading preventable cause of death in the U.S.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$CMND Hedge Fund Activity
We have seen 6 institutional investors add shares of $CMND stock to their portfolio, and 2 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- GOTHAM ASSET MANAGEMENT, LLC added 339,008 shares (+inf%) to their portfolio in Q3 2024
- UBS GROUP AG added 141,337 shares (+inf%) to their portfolio in Q3 2024
- ADVISORSHARES INVESTMENTS LLC added 42,000 shares (+32.6%) to their portfolio in Q3 2024
- SUSQUEHANNA INTERNATIONAL GROUP, LLP removed 23,981 shares (-100.0%) from their portfolio in Q2 2024
- CITADEL ADVISORS LLC added 17,729 shares (+inf%) to their portfolio in Q3 2024
- GEODE CAPITAL MANAGEMENT, LLC removed 16,586 shares (-100.0%) from their portfolio in Q3 2024
- HRT FINANCIAL LP added 12,756 shares (+inf%) to their portfolio in Q3 2024
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
Vancouver, Canada, Dec. 24, 2024 (GLOBE NEWSWIRE) -- 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 effects
1
. 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 Relations
invest@clearmindmedicine.com
Telephone: (604) 260-1566
US:
CMND@crescendo-ir.com
General Inquiries
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.
This article was originally published on Quiver News, read the full story.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
