Latest news with #AlcoholUseDisorder
Associated Press
a day ago
- Business
- Associated Press
Clearmind Medicine Announces IRB Approval for Phase 1/2a Clinical Trial for Alcohol Use Disorder at Tel Aviv Sourasky Medical Center
Vancouver, Canada, July 03, 2025 (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 that it has received Institutional Review Board (IRB) approval from Tel Aviv Sourasky Medical Center (TASMC) in Tel Aviv, Israel, for its ongoing Phase 1/2a clinical trial evaluating CMND-100, a proprietary MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder (AUD). This approval will enable patient enrollment at TASMC, a leading clinical site in Israel, prior to commencing this first-in-human trial at the site. The trial includes other first-in-class institutions, such as Yale School of Medicine's Department of Psychiatry, Johns Hopkins University School of Medicine and Hadassah-University Medical Center in Jerusalem, Israel. The study at TASMC will be led by Dr. David Zeltser, Director of the Emergency Medicine Department and Deputy Director R&D and Innovation. Clearmind recently announced the dosing of the first participant in the trial, marking a historic step toward developing a novel therapy for the millions affected by AUD worldwide. IRB approval from TASMC follows Clearmind's prior regulatory milestones, including U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application and IRB approvals from other clinical sites. 'We are pleased to receive IRB approval from Tel Aviv Sourasky Medical Center, a renowned institution, for our Phase 1/2a clinical trial,' said Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine. 'This milestone brings us closer to potentially offering a transformative treatment for individuals struggling with AUD, a condition that devastates millions of lives. With TASMC's participation, alongside leading centers like Yale and Johns Hopkins, we believe that we are well-positioned to advance our mission of developing safe, effective, and innovative psychedelic-derived therapies.' Clearmind's clinical trial is a critical step in addressing the global burden of AUD, which accounts for 4.7% of all deaths worldwide, according to the World Health Organization. The Company anticipates further progress in patient enrollment and data collection across its clinical sites, with the goal of delivering a breakthrough solution for those affected by AUD and their families. The Phase 1/2a clinical trial, a multinational, multi-center study, is designed to assess the safety, tolerability, and pharmacokinetic profile of CMND-100, while also evaluating its preliminary efficacy in reducing alcohol cravings and consumption in patients with AUD. 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 31 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: or contact: Investor Relations [email protected] Telephone: (604) 260-1566 US: [email protected] General Inquiries [email protected] 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 potentially offering a transformative treatment for individuals struggling with Alcohol Use Disorder, its belief that it is well-positioned to advance its mission of developing safe, effective, and innovative psychedelic-derived therapies and its anticipation of further progress in patient enrollment and data collection across its clinical sites, with the goal of delivering a breakthrough solution for those affected by AUD and their families. 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, 2024 and subsequent filings 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.
Associated Press
4 days ago
- Business
- Associated Press
Clearmind Medicine Announces First Participant Ever Dosed with its CMND-100 Treatment in Groundbreaking Clinical Trial for Alcohol Use Disorder
Vancouver, Canada, June 30, 2025 (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 a historic milestone: the first participant has been dosed with CMND-100, its proprietary MEAI-based oral drug candidate, in its Phase I/IIa clinical trial for the treatment of Alcohol Use Disorder (AUD). This marks the first time a patient has received Clearmind's innovative treatment in a clinical setting, a critical step toward the development of a potential new therapy for millions affected by AUD worldwide. The dosing follows the Company's announcement on June 5, 2025, of the enrollment of the first participant in the trial, which is being conducted at leading clinical sites, including Yale School of Medicine's Department of Psychiatry and Johns Hopkins University School of Medicine in the United States as well as Tel Aviv Sourasky Medical Center (Ichilov) and Hadassah-University Medical Center in Jerusalem. The Phase I/IIa trial is designed to evaluate the safety, tolerability, and pharmacokinetic profile of CMND-100, while also assessing its preliminary efficacy in reducing alcohol cravings and consumption in patients with AUD. 'Dosing the first participant with CMND-100 in our study marks a landmark achievement towards the development of a new solution and offering new hope for the massive, underserved community suffering from alcoholism,' said Dr. Adi Zuloff-Shani, Ph. D, CEO of Clearmind Medicine. 'This exciting event marks the first time our proprietary neuroplastogen compound has been given to humans under controlled clinical trial settings, bringing us closer to potentially delivering a revolutionary treatment for the millions of individuals and families suffering from AUD.' The Phase I/IIa clinical trial is a multinational, multicenter, single- and multiple-dose study that aims to establish the safety and optimal dosing of CMND-100. The trial will also explore early signals of efficacy, including reductions in alcohol consumption and cravings, which could pave the way for further development of this groundbreaking therapy. 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 31 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: or contact: Investor Relations [email protected] Telephone: (604) 260-1566 US: [email protected] General Inquiries [email protected] 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 CMND-100 being a potential new therapy for millions affected by AUD worldwide and the Company potentially delivering a revolutionary treatment for the millions of individuals and families suffering from AUD. 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, 2024 and subsequent filings 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.
Yahoo
25-06-2025
- Business
- Yahoo
Clearmind Medicine Enrolls First Patient in its Clinical Trial for Alcoholism Treatment
CMND-100 has the potential to provide an innovative and advanced treatment option for hundreds of millions of people around the world afflicted with Alcohol Use Disorder Vancouver, Canada, June 25, 2025 (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, recently announced the enrollment of the first patient in its Phase I/IIa clinical trial for CMND-100, the Company's proprietary MEAI-based oral drug candidate for the treatment of Alcohol Use Disorder (AUD). The first patient was enrolled at Yale School of Medicine's Department of Psychiatry, marking a significant milestone in the trial. The trial is evaluating the safety, tolerability, and pharmacokinetic profile of CMND-100, with preliminary efficacy assessments to explore its potential in reducing alcohol cravings and consumption. This first-in-human study represents a pivotal step toward developing a groundbreaking treatment for individuals struggling with AUD. Eligible subjects for the clinical trial, among others, are individuals aged 18 to 60. Participants may be either non-treatment-seeking individuals who report heavy binge drinking (defined as at least five standard drinks in a day for men or at least four for women) on at least five days in the past month prior to screening, or treatment-seeking individuals diagnosed with Alcohol Use Disorder (AUD) per DSM-5 criteria, who report at least four binge drinking days in the month prior to screening. All subjects must express a desire to reduce or stop drinking. For more information: Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine said:'This advancement brings us one step closer to offering an innovative solution for those affected by AUD, a condition with significant unmet medical needs. The substance use disorder treatment market in the U.S. alone was valued at $35.1 billion in 2021 and is projected to grow to $60.2 billion by 2029. Moreover, there are hundreds of millions of individuals around the globe afflicted by AUD. However, the market has been constrained due to the limited effectiveness and adverse side effects of current treatment options. We are executing on our development strategy and are optimistic about the potential of our MEAI-based therapy to offer a safe, effective solution that can transform lives.' The Phase I/IIa clinical trial is being conducted at multiple sites, including Yale School of Medicine and Johns Hopkins University School of Medicine, while the Company is valuating additional clinical sites. Clearmind remains committed to advancing its robust intellectual property portfolio and pioneering psychedelic-derived therapeutics to address global health challenges. 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 31 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: or contact: Investor Relationsinvest@ Telephone: (604) 260-1566US: CMND@ General InquiriesInfo@ 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 conducting its Phase I/IIa clinical trial, developing a treatment for individuals struggling with AUD, the size of the substance use disorder treatment market, executing its development strategy, valuating additional clinical sites, and that it remains committed to advancing its robust intellectual property portfolio and pioneering psychedelic-derived therapeutics to address global health challenges. 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, 2024 and subsequent filings 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.
Yahoo
11-06-2025
- Business
- Yahoo
EXCLUSIVE: Adial Pharmaceuticals Lead Candidate For Alcohol Use Disorder Advances Toward Phase 3 Trial
Adial Pharmaceuticals, Inc. (NASDAQ:ADIL) on Wednesday announced progress in the design and planning of its upcoming Phase 3 trial evaluating AD04, the company's lead investigational genetically targeted, serotonin-3 receptor antagonist, a therapeutic agent for Alcohol Use Disorder (AUD) in heavy drinking patients (defined as < 8 drinks/day). As part of its Phase 3 trial preparation, Adial engaged Cytel Inc., a provider of data science and advanced statistical methodologies for clinical trials, to provide expert support on trial design and data interrogation. Cytel's contributions have helped inform key design elements of Adial's upcoming trial, which aims to maximize efficiency, cost-effectiveness, and the likelihood of part, Cytel's efforts identified specific genetic subpopulations potentially more responsive to AD04, enabling a refined Phase 3 strategy that aligns with clinical and regulatory expectations. Post-hoc historical clinical trial data analyses identified genotype-defined patient subgroups likely to benefit most from AD04. This supports Adial's precision medicine approach in the upcoming Phase 3 trial, which targets higher efficacy and commercial differentiation. Adial partnered with Cytel to apply advanced statistical analytics and simulation modeling to optimize the trial design, enable adaptive enrichment, and align with regulatory expectations. The Phase 3 trial is expected to begin in late 2025, with the potential for interim analysis-driven readouts supporting a streamlined path to potential regulatory submission. Adial said in a statement on Wednesday that AD04 represents a first-in-class opportunity in the multi-billion-dollar global AUD market and that its refined clinical strategy will accelerate value realization. In May, the U.S. Food and Drug Administration (FDA) granted the company's request for an End of Phase 2 meeting to discuss its proposed clinical development plan and seek the U.S. Food and Drug Administration (FDA) guidance on the Phase 3 trial for AD04. The meeting will take place on July 25, 2025. The United States Patent and Trademark Office (USPTO) issued patent number 12,274,692 to AD04 in May. The patent covers a method of treating alcohol-related diseases and opioid-related disorders using AD04 in genetically identified patients. Price Action: ADIL stock closed at $0.59 on Tuesday. Read Next:UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? This article EXCLUSIVE: Adial Pharmaceuticals Lead Candidate For Alcohol Use Disorder Advances Toward Phase 3 Trial originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
05-06-2025
- Business
- Yahoo
Clearmind Medicine Announces Enrollment of First Patient in Phase I/IIa Clinical Trial for Alcohol Use Disorder Treatment
CMND-100 has the potential to provide an innovative and advanced treatment option for hundreds of millions of people around the world afflicted with Alcohol Use Disorder Vancouver, Canada, June 05, 2025 (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 the enrollment of the first patient in its Phase I/IIa clinical trial for CMND-100, a proprietary MEAI-based oral drug candidate aimed at treating Alcohol Use Disorder (AUD). The first patient was enrolled at Yale School of Medicine's Department of Psychiatry, marking a significant milestone in the trial. The trial is evaluating the safety, tolerability, and pharmacokinetic profile of CMND-100, with preliminary efficacy assessments to explore its potential in reducing alcohol cravings and consumption. This first-in-human study represents a pivotal step toward developing a groundbreaking treatment for individuals struggling with AUD. Eligible subjects for the clinical trial, among others, are individuals aged 18 to 60. Participants may be either non-treatment-seeking individuals who report heavy binge drinking (defined as at least five standard drinks in a day for men or at least four for women) on at least five days in the past month prior to screening, or treatment-seeking individuals diagnosed with Alcohol Use Disorder (AUD) per DSM-5 criteria, who report at least four binge drinking days in the month prior to screening. All subjects must express a desire to reduce or stop drinking. For more information: 'The enrollment of our first patient at Yale School of Medicine marks a pivotal milestone in the development of CMND-100,' said Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine. 'This advancement brings us one step closer to offering an innovative solution for those affected by AUD, a condition with significant unmet medical needs. The substance use disorder treatment market in the U.S. alone was valued at $35.1 billion in 2021 and is projected to grow to $60.2 billion by 2029. Moreover, there are hundreds of millions of individuals around the globe afflicted by AUD. However, the market has been constrained due to the limited effectiveness and adverse side effects of current treatment options. We are executing on our development strategy and are optimistic about the potential of our MEAI-based therapy to offer a safe, effective solution that can transform lives.' The Phase I/IIa clinical trial is being conducted at multiple sites, including Yale School of Medicine and Johns Hopkins University School of Medicine, while the Company is valuating additional clinical sites. Clearmind remains committed to advancing its robust intellectual property portfolio and pioneering psychedelic-derived therapeutics to address global health challenges. 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 31 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: or contact: Investor Relations invest@ Telephone: (604) 260-1566 US: CMND@ General Inquiries Info@ 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 conducting its Phase I/IIa clinical trial, developing a treatment for individuals struggling with AUD, the size of the substance use disorder treatment market, executing its development strategy, valuating additional clinical sites, and that it remains committed to advancing its robust intellectual property portfolio and pioneering psychedelic-derived therapeutics to address global health challenges. 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, 2024 and subsequent filings 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 in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
