Clearmind Medicine Receives IRB Approval for its FDA-Regulated Clinical Trial

Rhea-AI Summary

Clearmind Medicine (NASDAQ: CMND) 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 conducted at Yale School of Medicine's Department of Psychiatry under Dr. Anahita Bassir Nia's leadership. This FDA-regulated clinical program aims to evaluate the safety, tolerability, and efficacy of CMND-100 in reducing alcohol cravings and consumption among individuals with moderate to severe AUD.

The development addresses a significant global health issue, as alcohol consumption causes 2.6 million deaths annually worldwide and represents 4.7% of global deaths. Current AUD treatments face challenges including high costs, low efficacy (less than 30%), and poor patient compliance due to side effects.

Positive

• Received IRB approval for Phase I/IIa clinical trial
• Partnership with prestigious Yale School of Medicine
• Addresses large market with 2.6M annual deaths worldwide
• Targets treatment gap in current AUD therapies with <30% efficacy

Negative

• None.

Insights

Clinical Research Analyst

The IRB approval from Yale for Clearmind Medicine's Phase I/IIa trial represents a important regulatory milestone. The study design targeting both safety and efficacy endpoints for CMND-100 in AUD treatment follows standard FDA clinical development pathways. The multi-site approach strengthens data collection potential, while the leadership of Dr. Bassir Nia adds credibility given her expertise in addiction medicine. The trial addresses a significant market opportunity, with AUD affecting millions globally and current treatments showing efficacy (<percent>30%</percent>). The focus on both reducing cravings and consumption provides clear, measurable endpoints. However, early-stage trials carry inherent risks and success in Phase I/IIa doesn't guarantee final approval. The fact that this is an FDA-regulated program adds regulatory clarity but also increases development costs and timelines compared to non-regulated alternatives.

Market Research Analyst

The global impact of AUD, causing <b>2.6 million deaths annually</b>, presents a substantial market opportunity for CMND-100. The <b>multi-billion dollar healthcare cost burden</b> associated with alcohol use creates strong economic incentives for effective treatments. Clearmind's positioning in the psychedelic-derived therapeutics space, particularly targeting a condition with low treatment efficacy rates, could capture significant market share if successful. The Yale affiliation enhances credibility for potential partnerships and future commercialization efforts. For a company with a market cap of <money>$5.3M</money>, this development could significantly impact valuation metrics. However, investors should note that the path to commercialization remains long and substantial capital requirements lie ahead for completing the clinical development program.

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 effects¹. 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

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 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.

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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.

FAQ

What is the purpose of Clearmind Medicine's (CMND) Phase I/IIa clinical trial?

The trial aims to evaluate the safety, tolerability, and efficacy of CMND-100 in treating alcohol use disorder (AUD), specifically focusing on reducing alcohol cravings and consumption in moderate to severe cases.

Where will Clearmind Medicine's (CMND) CMND-100 clinical trial be conducted?

The trial will be conducted at Yale School of Medicine's Department of Psychiatry, led by Dr. Anahita Bassir Nia, an expert in psychiatry and addiction medicine.

What market opportunity is Clearmind Medicine (CMND) targeting with CMND-100?

CMND is targeting the alcohol use disorder market, which accounts for 2.6 million deaths annually worldwide and represents 4.7% of global deaths, with current treatments showing less than 30% efficacy.

What regulatory approvals has Clearmind Medicine (CMND) received for its CMND-100 trial?

Clearmind Medicine has received Institutional Review Board (IRB) approval for its FDA-regulated Phase I/IIa clinical trial of CMND-100.