VANCOUVER - Clearmind Medicine Inc. (NASDAQ:CMND), (FSE:CWY0), a biotech firm specializing in psychedelic-derived therapeutics with a market capitalization of approximately $5 million, has announced the receipt of Institutional Review Board (IRB) approval for a Phase I/IIa clinical trial of its drug CMND-100, aimed at treating alcohol use disorder (AUD). According to InvestingPro data, the company maintains a healthy balance sheet with more cash than debt, though it remains unprofitable over the last twelve months. The trial will be conducted at the Yale School of Medicine’s Department of Psychiatry under the guidance of Dr. Anahita Bassir Nia, a recognized authority in psychiatry and addiction medicine.
This approval is a crucial step in Clearmind’s FDA-regulated clinical program and expands the trial to assess the safety, tolerability, and efficacy of CMND-100. Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine, stated that this brings the company closer to starting its innovative clinical trial for treating AUD patients. He highlighted the urgency of addressing AUD, citing its role in 2.6 million annual deaths worldwide and its status as the most commonly used substance among Americans 12 and older.
The clinical trial will evaluate CMND-100's potential to reduce alcohol cravings and consumption in individuals with moderate to severe AUD. This research is part of Clearmind's broader effort to advance CMND-100 through the clinical pipeline. Trading at $1.22, the stock has experienced significant volatility, with InvestingPro analysis showing a 52-week range of $0.92 to $3.58.
Clearmind Medicine Inc. focuses on developing psychedelic-based compounds for widespread and underserved health issues like AUD. The company holds an intellectual portfolio of nineteen patent families, including 29 granted patents. With shares traded on the Nasdaq and the Frankfurt Stock Exchange, Clearmind aims to research and potentially commercialize these compounds as regulated medicines, foods, or supplements.
This press release contains forward-looking statements regarding the timing and potential impact of the clinical trial and the company's strategic approach to AUD treatment. These statements are subject to risks and uncertainties that could cause actual results to differ materially from expectations. InvestingPro rates Clearmind's overall financial health as 'WEAK' with a score of 1.69 out of 5, reflecting current challenges in profitability and market performance. The information is based on a press release statement, and the company has no obligation to update any forward-looking statements. Subscribers to InvestingPro can access 4 additional ProTips and comprehensive financial analysis for CMND.
In other recent news, Clearmind Medicine Inc., a biotech firm, has received Institutional Review Board (IRB) approval for part A of its Phase I/IIa clinical trial in the United States. The trial aims to evaluate the safety, tolerability, and pharmacokinetics of CMND-100, a potential treatment for alcohol use disorder (AUD). The U.S. Food and Drug Administration (FDA) and the Israeli Ministry of Health have endorsed the trial, which will take place at several prestigious institutions, including Johns Hopkins University and Yale School of Medicine.
In other developments, Clearmind has secured a new US patent for its MEAI-based binge behavior regulator program, adding to its robust intellectual property portfolio. The firm has also published several international patent applications, including novel treatments for addiction and mental health disorders, developed in collaboration with SciSparc Ltd. and Yissum Research Development Company.
Furthermore, Clearmind has submitted a patent application for novel compounds aimed at treating post-traumatic stress disorder (PTSD) and other mental health issues. The company has also entered a strategic partnership with JS First Sdn. Bhd. to expand the reach of its novel MEAI-based non-alcoholic beverages into international markets. These are the recent developments in Clearmind's research and innovation in the field of biotechnology.
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