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Clearmind Medicine Announces Successful Completion of Second Cohort Enrollment in Ongoing FDA-Approved Phase I/IIa Trial for CMND-100
Globenewswire· 2025-12-16 13:45
Core Insights - Clearmind Medicine Inc. has successfully completed patient enrollment for the second cohort in its FDA-approved Phase I/IIa clinical trial for CMND-100, an oral drug candidate aimed at treating Alcohol Use Disorder (AUD) [1][4] - The first cohort showed promising safety and efficacy results, indicating a favorable safety profile and preliminary signs of reduced cravings and withdrawal symptoms [2][4] - The rapid enrollment of the second cohort underscores the commitment of collaborating clinical centers to advance innovative treatments for AUD, a condition with limited effective options affecting millions globally [3][4] Company Overview - Clearmind is a clinical-stage biotech company focused on developing novel neuroplastogen-derived therapeutics to address under-treated health issues, particularly AUD [1][5] - The company holds an intellectual property portfolio consisting of nineteen patent families and 31 granted patents, with plans to seek additional patents and acquire more intellectual property [6] Clinical Trial Details - The multinational Phase I/IIa trial aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CMND-100 in patients with moderate to severe AUD, with dosing for the second cohort expected to start soon [4]
Clearmind Medicine Advances CMND-100 to Dosing Phase at Hadassah Medical Center in Ongoing Phase I/IIa Clinical Trial for Alcohol Use Disorder
Globenewswire· 2025-12-02 12:57
Core Insights - Clearmind Medicine Inc. has enrolled and dosed the first participant in its Phase I/IIa clinical trial for Alcohol Use Disorder (AUD) with its proprietary drug candidate CMND-100 at Hadassah-University Medical Center in Jerusalem, marking a significant milestone in the trial [1][2][3] Company Overview - Clearmind is a clinical-stage biotech company focused on developing novel neuroplastogen-derived therapeutics to address major under-treated health issues, including AUD [1][4] - The company aims to research and commercialize psychedelic-based compounds as regulated medicines, foods, or supplements [4] Clinical Trial Details - The trial at Hadassah-University Medical Center is led by Prof. Joseph Caraco and evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of CMND-100 in AUD patients [2] - Recent positive results from the first cohort and a unanimous recommendation from the Data and Safety Monitoring Board support the continuation of the trial [2] Intellectual Property - Clearmind's intellectual portfolio includes nineteen patent families with 31 granted patents, and the company plans to seek additional patents as warranted [5]
Clearmind Medicine Kicks-Off Patient Enrollment at Tel Aviv Sourasky Medical Center, Adding Another Site Activated in its in Phase I/IIa Alcohol Use Disorder Trial
Globenewswire· 2025-11-25 12:17
Core Insights - Clearmind Medicine Inc. has commenced patient enrollment for its Phase I/IIa clinical trial of CMND-100 for Alcohol Use Disorder (AUD) at Tel Aviv Sourasky Medical Center, marking a significant milestone in the global study [1][2][4] - The trial aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CMND-100, a non-hallucinogenic, oral MEAI-based compound, with initial results indicating excellent safety and adherence [3][4] - Clearmind's intellectual property portfolio includes nineteen patent families with 31 granted patents, and the company plans to pursue additional patents to enhance its portfolio [5] Company Overview - Clearmind is a clinical-stage biotech company focused on developing novel neuroplastogen-derived therapeutics to address under-treated health issues, particularly AUD [1][4] - The company is committed to researching and commercializing psychedelic-based compounds as regulated medicines, foods, or supplements [4] Clinical Trial Details - The Phase I/IIa trial is being conducted at multiple prestigious sites, including Yale School of Medicine and Johns Hopkins University, in addition to TASMC [2] - The first completed cohort of the trial has shown no serious adverse events, indicating a positive safety profile for CMND-100 [3]
Clearmind Medicine's Data and Safety Monitoring Board Unanimously Approves Continuation of Phase I/IIa Clinical Trial for CMND-100 Following Positive Interim Safety Review
Globenewswire· 2025-11-24 13:51
Core Insights - Clearmind Medicine Inc. has received a positive recommendation from its independent Data and Safety Monitoring Board (DSMB) to continue its Phase I/IIa clinical trial for CMND-100, a non-hallucinogenic neuroplastogen aimed at treating Alcohol Use Disorder (AUD) [1][2][3] Group 1: Clinical Trial Details - The ongoing multinational, multi-center trial is assessing the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of CMND-100 in reducing alcohol cravings and consumption among individuals with moderate to severe AUD [2] - The DSMB's review highlighted a favorable safety profile with no serious adverse events reported and general good tolerability across all participants [6] Group 2: Company Statements and Future Outlook - The CEO of Clearmind expressed confidence in CMND-100's safety and therapeutic potential, indicating that the positive interim data positions the company to accelerate enrollment in the trial [3] - The DSMB was established in 2023 to ensure patient safety and data integrity throughout the trial, reflecting the company's commitment to ethical clinical development [3] Group 3: Company Background and Intellectual Property - Clearmind is focused on developing novel psychedelic-derived therapeutics to address significant health issues, including AUD, with the goal of commercializing these compounds as regulated medicines [4] - The company holds an intellectual property portfolio consisting of nineteen patent families, including 31 granted patents, and plans to seek additional patents as warranted [5]
Clearmind Medicine Accelerate FDA-Approved Alcohol Use Disorder Clinical Trial by Activating Fifth Elite Global Medical Site
Globenewswire· 2025-11-20 11:01
Core Insights - Clearmind Medicine Inc. has initiated its FDA-approved Phase I/IIa clinical trial for CMND-100 at Hadassah Medical Center, expanding the trial's reach and emphasizing the potential of this non-hallucinogenic MEAI-based oral drug candidate for treating Alcohol Use Disorder (AUD) [1][2] Group 1: Clinical Trial Details - The multinational study aims to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of CMND-100 in reducing alcohol cravings and consumption among individuals with moderate to severe AUD [2] - Hadassah Medical Center was added as a clinical site for the ongoing trial, which was activated swiftly following final approval earlier in the month [2] Group 2: Early Findings - Top-line data from the first cohort of the clinical trial indicated a favorable safety profile, with no serious adverse events reported and high adherence to the dosing regimen [3] - These early findings support the ongoing evaluation of CMND-100 as a potential breakthrough therapy for AUD, a condition affecting millions globally [3] Group 3: Company Overview - Clearmind is a clinical-stage biotech company focused on developing novel psychedelic-derived therapeutics to address under-treated health issues, including AUD [4] - The company's intellectual portfolio includes nineteen patent families with 31 granted patents, and it plans to seek additional patents as warranted [5]
Clearmind Medicine Accelerate FDA-Approved Alcohol Use Disorder Clinical Trial by Activating Fifth Elite Global Medical Site
Globenewswire· 2025-11-20 11:01
Core Insights - Clearmind Medicine Inc. has initiated its FDA-approved Phase I/IIa clinical trial for CMND-100 at Hadassah Medical Center, expanding the trial's reach and emphasizing the potential of this non-hallucinogenic MEAI-based oral drug candidate for treating Alcohol Use Disorder (AUD) [1][2] Group 1: Clinical Trial Details - The multinational study aims to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of CMND-100 in reducing alcohol cravings and consumption among individuals with moderate to severe AUD [2] - Hadassah Medical Center was added as a clinical site following final approval earlier in November 2025, indicating swift activation and commitment to the trial [2] Group 2: Early Findings - Top-line data from the first cohort of the clinical trial showed a favorable safety profile with no serious adverse events reported, indicating that the treatment was well-tolerated among participants [3] - High adherence to the dosing regimen and protocol requirements was observed, supporting the feasibility and patient acceptability of CMND-100 in a clinical setting [3] Group 3: Company Overview - Clearmind is focused on the discovery and development of novel psychedelic-derived therapeutics to address widespread health issues, including AUD [4] - The company holds an intellectual property portfolio consisting of nineteen patent families and 31 granted patents, with plans to seek additional patents as warranted [5]
Clearmind Medicine Files Israeli Patent for Novel Non-Hallucinogenic Neuroplastogen Treatment for Depression
Globenewswire· 2025-11-17 12:55
Core Insights - Clearmind Medicine Inc. has filed a patent application in Israel for a combination therapy targeting depression, utilizing 5-methoxy-2-aminoindane (MEAI) and N-Acylethanolamines like Palmitoylethanolamide (PEA) [1][2] - The collaboration with Neurothera Labs Inc. aims to address the significant global issue of major depressive disorder, which affects over 280 million people and is a leading cause of disability [2] - The CEO of Clearmind emphasized the importance of this patent application as a milestone in developing innovative treatments for mental health conditions, highlighting the lag in treatment innovation for depression [3] Company Overview - Clearmind is a clinical-stage biotech company focused on developing psychedelic-derived therapeutics to address under-treated health issues, including alcohol use disorder [4] - The company has an extensive intellectual property portfolio, currently consisting of 19 patent families and 31 granted patents, with plans to seek additional patents as warranted [5] Research and Development - The new patent filing expands Clearmind's intellectual property related to MEAI and N-Acylethanolamines, targeting various conditions such as alcohol use disorder, cocaine addiction, obesity, and depression [3] - Preclinical data supports the efficacy of MEAI in reducing addictive behaviors while maintaining normal reward pathways [3]
Clearmind Medicine Receives Final Approval to Expand its FDA Regulated Phase 1/2a Clinical Trial for Alcohol Use Disorder at Hadassah Medical Center
Globenewswire· 2025-11-13 13:54
Core Viewpoint - Clearmind Medicine Inc. has received final approval for its Phase 1/2a clinical trial of CMND-100, a drug candidate for treating Alcohol Use Disorder (AUD), from Hadassah Medical Center in Israel, marking a significant step in addressing AUD, which is responsible for 4.7% of global deaths [1][3]. Group 1: Clinical Trial Details - The clinical trial will involve prestigious institutions such as Yale School of Medicine, Johns Hopkins University, and Tel Aviv Sourasky Medical Center, with leadership from Prof. Joseph Caraco at Hadassah [2]. - The trial aims to assess the safety, tolerability, and pharmacokinetic profile of CMND-100, while also evaluating its preliminary efficacy in reducing alcohol cravings and consumption among AUD patients [3]. Group 2: Company Overview - Clearmind is focused on developing novel psychedelic-derived therapeutics to address significant health issues, including AUD, with the goal of commercializing these compounds as regulated medicines, foods, or supplements [4]. - The company holds an intellectual property portfolio consisting of nineteen patent families and 31 granted patents, with plans to seek additional patents as necessary [5].
Clearmind Medicine Announces Notice of Patent Publication for Depression Treatment
Globenewswire· 2025-11-12 11:25
Core Insights - Clearmind Medicine Inc. has received notice of publication from the China National Intellectual Property Administration for its proprietary non-hallucinogenic compound, 5-methoxy-2-aminoindane (MEAI), aimed at treating depression [1] - Major depressive disorder affects over 280 million people globally and is a leading cause of disability, with limited innovative treatment options available [2] - Preclinical studies indicate that MEAI may enhance mood regulation and reduce anhedonia, providing a differentiated therapeutic approach for patients unresponsive to conventional antidepressants [3] - Clearmind's intellectual property portfolio includes 19 patent families and 31 granted patents, with plans to seek additional patents and acquire more intellectual property [4] Company Overview - Clearmind is a clinical-stage psychedelic pharmaceutical biotech company focused on developing novel psychedelic-derived therapeutics to address widespread health issues, including alcohol use disorder [4] - The company aims to research and commercialize psychedelic-based compounds as regulated medicines, foods, or supplements [4] - Clearmind's shares are traded on Nasdaq under the symbol "CMND" and on the Frankfurt Stock Exchange under "CWY0" [5]
Clearmind Medicine Successfully Completed First Cohort Treatment in its FDA-Approved Phase I/IIa Clinical Trial for Alcohol Use Disorder
Globenewswire· 2025-11-10 13:07
Core Insights - Clearmind Medicine Inc. has completed the treatment of the first patient cohort in its Phase I/IIa clinical trial for CMND-100, targeting Alcohol Use Disorder (AUD) [1][5] - The global alcohol-dependency treatment market is projected to grow from approximately $13.2 billion in 2024 to about $20 billion by 2032, indicating a significant unmet need for effective treatments [4] Company Overview - Clearmind is a clinical-stage biotech company focused on developing psychedelic-derived therapeutics to address under-treated health issues, including AUD [6] - The company holds an intellectual property portfolio consisting of nineteen patent families and 31 granted patents, with plans to seek additional patents as necessary [7] Clinical Trial Details - The Phase I/IIa trial is designed to assess the safety, tolerability, and pharmacokinetic profile of CMND-100, while also exploring preliminary efficacy signals such as reductions in alcohol cravings and consumption [3] - The trial includes participants from leading research centers, with six patients successfully enrolled and treated, including two from Johns Hopkins University and four from Yale School of Medicine [2][3]