Clearmind Medicine Starts First Human Trial of CMND-100 for Alcohol Use Disorder

Clearmind Medicine Inc., a pioneering clinical-stage biotech company, has embarked on a significant new clinical trial aimed at addressing Alcohol Use Disorder (AUD) through their innovative drug platform CMND-100. Based in Vancouver, Canada, Clearmind focuses on developing novel therapeutics derived from psychedelics to tackle major, under-treated health issues. The recent launch of their Phase I/IIa clinical trial represents the first human testing of CMND-100, marking a crucial milestone in the company's journey to revolutionize addiction and mental health treatments.

CMND-100, a proprietary MEAI-based oral drug candidate, is designed to provide a breakthrough approach to treating AUD. Unlike traditional therapies, this drug aims to alter the reward mechanisms tied to addictive behaviors, potentially offering a more effective solution. The initial trial site at IMCA in Israel is led by Professor Mark Weiser of the Sheba Medical Center, noted for his expertise in psychiatric disorders such as substance abuse, depression, and cognitive impairment.

Dr. Adi Zuloff-Shani, Clearmind’s CEO, remarked on the transition of the company into a clinical-stage pharmaceutical entity as a significant achievement. This advancement allows them to assess if the promising outcomes observed in animal studies will be applicable to human subjects struggling with AUD. The preclinical data previously disclosed by the company indicates CMND-100's potential as a novel approach to treating alcoholism, addressing a critical unmet medical need.

The Phase I/IIa trial's primary objectives include evaluating the safety, tolerability, and pharmacokinetics of CMND-100 in individuals diagnosed with AUD. The study will also conduct preliminary efficacy assessments to determine the drug's effectiveness in reducing alcohol cravings and consumption. Besides the IMCA Center in Israel, the trial will extend to two esteemed U.S. institutions: Yale School of Medicine’s Department of Psychiatry and Johns Hopkins University School of Medicine.

Alcohol Use Disorder poses a severe global health challenge, affecting millions worldwide with dire consequences such as liver disease, cardiovascular issues, and mental health disorders. The World Health Organization reports that around 400 million people aged 15 and older suffer from alcohol use disorders, with 209 million experiencing alcohol dependence. This disorder contributes to 2.6 million deaths annually, comprising 4.7% of all global fatalities. Significantly, 13% of these deaths occur among individuals aged 20 to 39, highlighting the vulnerability of younger populations.

In the United States, the prevalence of AUD among young adults is particularly concerning. The 2023 National Survey on Drug Use and Health (NSDUH) revealed that 15.1% of adults aged 18 to 25 met the criteria for past-year AUD. This statistic underscores the urgent need for innovative therapeutic interventions that Clearmind Medicine aims to fulfill with CMND-100.

Clearmind Medicine Inc. stands at the forefront of psychedelic pharmaceutical biotechnology, with a mission to discover and develop novel therapeutics for widespread and underserved health issues like AUD. The company's primary goal is to research and develop psychedelic-based compounds and eventually bring them to market as regulated medicines, foods, or supplements. Clearmind's intellectual property portfolio comprises nineteen patent families, including 31 granted patents. The company continues to seek additional patents to strengthen its portfolio further and remains open to acquiring additional intellectual property as opportunities arise.

Shares of Clearmind Medicine Inc. are publicly traded on Nasdaq under the symbol "CMND" and on the Frankfurt Stock Exchange under "CWY0." Through these developments, Clearmind Medicine is poised to make a transformative impact on the treatment of Alcohol Use Disorder, offering hope to millions grappling with this pervasive health issue.