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NEW YORK - Clearmind Medicine Inc. (NASDAQ:CMND), a micro-cap biotech company with a market capitalization of $4.6 million and a current stock price of $0.90, has enrolled the first patient in its Phase I/IIa clinical trial for CMND-100, the company’s oral drug candidate for treating Alcohol Use Disorder (AUD), according to a press release statement. According to InvestingPro analysis, the company maintains a healthy balance sheet with more cash than debt.
The enrollment took place at Yale School of Medicine’s Department of Psychiatry. The trial will evaluate safety, tolerability, and pharmacokinetic profile of CMND-100, while also conducting preliminary efficacy assessments on reducing alcohol cravings and consumption.
The study includes participants aged 18 to 60 who either report heavy binge drinking on at least five days in the past month (non-treatment-seeking individuals) or are diagnosed with AUD and report at least four binge drinking days in the month prior to screening (treatment-seeking individuals). All participants must express a desire to reduce or stop drinking.
The clinical trial is being conducted at multiple sites, including Yale School of Medicine and Johns Hopkins University School of 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," said Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine. The company’s stock has faced challenges, with InvestingPro data showing a 48% decline over the past six months, though it maintains a favorable current ratio of 1.74.
CMND-100 is based on MEAI, a psychedelic-derived compound. The company describes this first-in-human study as a pivotal step toward developing a treatment for individuals struggling with AUD.
Clearmind Medicine is a clinical-stage psychedelic pharmaceutical biotech company focused on developing novel psychedelic-derived therapeutics. The company’s intellectual portfolio currently consists of nineteen patent families including 31 granted patents. While currently not profitable, with an EBITDA of -$5.85 million in the last twelve months, the company’s low debt-to-equity ratio of 0.02 suggests conservative financial management. For deeper insights into Clearmind Medicine’s financial health and growth prospects, investors can access additional analysis through InvestingPro, which offers exclusive metrics and investment tools.
In other recent news, Clearmind Medicine Inc. has expanded its Phase I/IIa clinical trial for its experimental drug CMND-100, aimed at treating Alcohol Use Disorder (AUD), by adding Tel Aviv Sourasky Medical Center as a new clinical site. This trial, which began at Johns Hopkins University School of Medicine, also includes Yale School of Medicine as a participant. The study focuses on evaluating the safety and pharmacokinetic profile of CMND-100, as well as its potential to reduce alcohol cravings. In addition, Clearmind Medicine has engaged a consulting firm to navigate regulatory frameworks for its psychedelic-based treatments, aiming to integrate these therapies into mainstream healthcare.
Further developments include Clearmind’s collaboration with SciSparc Ltd. to file an international patent application for a new treatment targeting eating disorders such as anorexia and bulimia. This proposed therapy combines 3-Methylmethcathinone (3-MMC) with Palmitoylethanolamide (PEA) to address complex neurobiological and psychological factors. Clearmind Medicine is also committed to expanding its intellectual property portfolio, which currently consists of 19 patent families and 31 granted patents. The company continues to focus on developing psychedelic-derived therapeutics, with its lead candidate CMND-100 actively being studied for its efficacy in treating AUD.
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