Clearmind Medicine Obtains Clearance for its Psychedelic- Based Alcoholism Clinical Trial
Clearmind Medicine Inc. receives approval to commence phase I/IIa clinical trial for alcohol use disorder patients using proprietary CMND-100 oral capsule. The trial aims to evaluate safety, pharmacokinetics, and efficacy of the novel psychedelic-derived therapeutic in reducing alcohol consumption.
The approval of Clearmind Medicine's phase I/IIa clinical trial for CMND-100 presents a significant step in the development of novel treatments for alcohol use disorder (AUD). The trial's primary endpoint, determining the tolerable dose and characterizing the safety and pharmacokinetics/pharmacodynamics of CMND-100, is pivotal for establishing a foundation for future studies and potential treatment protocols. The secondary endpoint, assessing the preliminary efficacy in reducing drinking patterns and cravings, addresses a substantial need for innovative therapies in the realm of addiction medicine.
MEAI's unique properties as a non-hallucinogenic, psychoactive substance that targets serotonergic and adrenergic receptors, as well as monoamine transporters, suggest a novel mechanism of action that could offer advantages over existing treatments. Current treatments for AUD, such as naltrexone and acamprosate, have limitations in efficacy and patient adherence. If CMND-100 demonstrates favorable outcomes, it could revolutionize the approach to AUD treatment and potentially impact the broader field of addiction therapy.
Clearmind Medicine's progression to clinical-stage development marks a crucial transition that could influence investor sentiment and the company's valuation. The commencement of the clinical trial at prestigious institutions such as Yale and Johns Hopkins lends credibility to the endeavor and may attract the attention of institutional investors and pharmaceutical partners. The successful advancement through clinical phases typically results in significant stock price movements and early-stage results, if positive, could lead to an increase in market capitalization and investment interest.
However, investors should be aware of the inherent risks associated with biotech investments, particularly in the early stages of clinical trials. The long development timelines, regulatory hurdles and the need for substantial capital to fund research and development activities are factors to consider. The biotech sector is known for its volatility and outcomes of clinical trials are unpredictable. A balanced portfolio approach would be prudent for those considering exposure to this sector.
The interaction of MEAI with serotonergic and adrenergic receptors, along with monoamine transporters, is of particular interest from a pharmacological perspective. The serotonergic system's involvement in alcohol intake regulation and the alpha-2-adrenergic receptors' role in mediating alcohol drinking behavior suggest that MEAI could modulate the neurochemical pathways associated with addiction. The non-hallucinogenic aspect of MEAI could also reduce the risk of adverse psychological effects, a concern with other psychedelic-based treatments.
Understanding the pharmacokinetics and pharmacodynamics of CMND-100 will be essential for determining appropriate dosing regimens and predicting patient responses. The molecule's ability to induce a slight euphoric, alcohol-like experience without promoting dependence could be a game-changer in addiction treatment, offering a therapeutic experience that aligns with patients' needs for relief without the negative consequences of alcohol consumption.
03/13/2024 - 08:14 AM
Vancouver, Canada, March 13, 2024 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq, CSE: CMND), (FSE: CWY) (“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, announced that it has received approval from the Israeli Ministry of Health 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. The approval, previously announced on February 23, 2024, allows Clearmind to start its pioneering clinical trial.
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.
"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. “We believe that our non-hallucinogenic, psychedelic solution could be the answer to the global need for dedicated and effective treatments for addictions."
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 the 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 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 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
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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 its belief that its non-hallucinogenic, psychedelic solution could be the answer to the global need for 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.
What is the purpose of Clearmind Medicine Inc.'s phase I/IIa clinical trial for alcohol use disorder patients?
The purpose is to evaluate the safety, pharmacokinetics, and efficacy of the company's proprietary CMND-100 oral capsule in reducing alcohol consumption.
Who will lead the clinical trial in Israel for Clearmind Medicine Inc.?
Prof. Mark Weiser, M.D., head of the Psychiatric Division at the Sheba Medical Center in the Tel Aviv suburb of Ramat Gan, will lead the clinical trial in Israel.
What is the active ingredient in CMND-100 oral capsule?
The active ingredient is MEAI, an innovative, psychoactive, and non-hallucinogenic molecule that interacts with serotonergic receptors and alpha-2-adrenergic receptors.
What are the primary and secondary endpoints of the clinical trial for Clearmind Medicine Inc.?
The primary endpoint is to find the tolerable dose and characterize safety and pharmacokinetics/ pharmacodynamics. The secondary endpoint is to evaluate the preliminary efficacy of CMND-100 in reducing drinking patterns and cravings in individuals with AUD.
