Clearmind Medicine Receives Approval to Commence its Phase I/IIa Clinical Trial of CMND-100 for Alcohol Use Disorder
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Insights
The initiation of phase I/IIa clinical trials for Clearmind Medicine Inc.'s CMND-100 marks a significant step in the development of new therapeutic options for alcohol use disorder (AUD). The active compound, MEAI, presents a novel approach by targeting the serotonergic and adrenergic systems which are known to influence alcohol intake and addiction pathways. The pharmacological interest lies in MEAI's interaction with specific receptors like 5-HT1a, 5-HT2a and alpha-2-adrenergic receptors, as well as monoamine transporters such as DAT, NET and SERT. These targets are critical in the modulation of reward systems and the maintenance of addictive behaviors. The compound's non-hallucinogenic profile paired with a psychoactive, euphoric effect that mimics alcohol could offer therapeutic benefits without the disorienting experiences associated with other psychedelic substances. The safety profile and pharmacokinetics of MEAI will be crucial data points, as they will inform dosing regimens and potential side effects, which are paramount in the progression to later-stage trials.
The advancement of CMND-100 into clinical trials is a promising development for stakeholders in the biotech and pharmaceutical industries, particularly those invested in addiction treatment. The design of the study to include both healthy volunteers and AUD subjects allows for a comprehensive analysis of the drug's effects across a spectrum of physiological baselines. This dual approach will enable researchers to delineate the specific impacts of MEAI on individuals with AUD. Moreover, the multinational and multi-center nature of the trial could enhance the robustness of the data and potentially expedite the regulatory approval process across different regions. The secondary endpoint focusing on the reduction of drinking patterns and cravings is particularly relevant, as it addresses the behavioral aspect of AUD, which is a critical component in evaluating the efficacy of addiction treatments. If CMND-100 demonstrates significant efficacy, it could disrupt the current AUD treatment market and provide a much-needed alternative to existing therapies.
From an economic standpoint, the development of CMND-100 has the potential to impact the healthcare market substantially. AUD is a pervasive condition with significant direct and indirect costs to society, including healthcare expenditures, lost productivity and social consequences. An effective treatment could alleviate some of these economic burdens. The cost-effectiveness of CMND-100 will be an area of interest, as it must be balanced against the current standard of care. The drug's non-hallucinogenic nature may also lead to broader acceptance and lower barriers to entry in the market compared to traditional psychedelic therapies. It's essential to monitor the progression of these trials to assess the potential market size and competitive landscape. The success of CMND-100 could also attract more investment into the field of psychedelic-derived therapeutics, signaling a shift in how the medical community approaches treatment for addiction and other mental health disorders.
For the first time, patients with alcohol use disorder will receive the company's unique and proprietary psychedelic - MEAI
Vancouver, Canada, Feb. 23, 2024 (GLOBE NEWSWIRE) -- 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, is pleased to announce it has received approval from the Ministry of Health of Israel to commence its phase I/IIa clinical trial for alcohol use disorder (AUD) patients using the company's proprietary MEAI-based (5-methoxy-2-aminoindane) CMND-100 oral capsule.
"We are thrilled to receive approval to commence our phase I/IIa clinical trial for our lead drug candidate, CMND-100, which has been shown to be safe and effective in preclinical studies. This is the most important milestone for the company to date and marks our transition to a clinical- stage pharmaceutical company. The Clearmind team has been working tirelessly on the research and development of a novel treatment to the global epidemic of alcoholism. We are eager to continue our work with patients in need of help,” said Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine. “Our non-hallucinogenic, psychedelic solution could be the answer to the tremendous global need for groundbreaking, dedicated and effective treatments for addictions."
The clinical trial is a multinational, multi-center, single and multiple dose tolerability, safety and pharmacokinetic study of CMND-100 in healthy volunteers and AUD subjects. The Israeli study will be led by Prof. Mark Weiser, M.D., head of the Psychiatric Division at the Sheba Medical Center in the Tel Aviv suburb of Ramat Gan.
The company intends to have two additional sites in the United States for the phase I/IIa clinical trial, at the Yale School of Medicine’s Department of Psychiatry and the Johns Hopkins University School of Medicine.
The primary endpoint of the clinical trial is to find the tolerable dose and characterize the safety and pharmacokinetics/ pharmacodynamics of single and repeated doses of CMND-100 in healthy subjects and those with AUD. The secondary endpoint is to evaluate preliminary efficacy of CMND-100 in reduction of drinking patterns and cravings in individuals with moderate-to-severe AUD. Oral capsules will be administered and subjects treated by these oral capsules will report their drinking patterns and cravings for alcohol during the clinical trial.
The active ingredient in CMND-100 is MEAI, an innovative, psychoactive and non-hallucinogenic molecule that has been reported to reduce the desire to consume alcoholic beverages, while exerting a slight euphoric alcohol-like experience. MEAI was found to interact with the serotonergic receptors 5-HT1a and 5-HT2a. The serotonergic system is considered to play a key role in the regulation of alcohol intake, reward, preference, and dependence. MEAI was also found to interact with the alpha-2-adrenergic receptors α2A, α2B and α2C, as well as the plasma membrane monoamine transporters for dopamine (DAT), norepinephrine (NET) and serotonin (SERT). These receptors and transporters are believed to participate in mediating alcohol drinking behavior and could constitute important molecular targets for interventions that target drugs subject to abuse, such as alcohol.
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 fifteen 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 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 its transition to a clinical- stage pharmaceutical company and how its non-hallucinogenic, psychedelic solution could be the answer to the tremendous global need for groundbreaking, dedicated and effective treatments for addictions. 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 January 29, 2024. 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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