Clearmind’s AUD drug candidate arrives in the U.S. for trials

Published 21/03/2025, 14:34
Clearmind’s AUD drug candidate arrives in the U.S. for trials

VANCOUVER - Clearmind Medicine Inc. (NASDAQ:CMND), a biotech firm specializing in psychedelic-derived therapeutics with a current market capitalization of $6 million, announced the arrival of its drug candidate CMND-100 in the United States, a significant step as the company prepares for its Phase I/IIa clinical trials for Alcohol Use Disorder (AUD). The drug’s presence in the U.S. aligns with Clearmind’s schedule to begin its first-in-human trials.

CMND-100, an oral drug developed from the proprietary compound MEAI, aims to reduce alcohol consumption and cravings through a new mechanism of action. With over 28 million adults in the U.S. affected by AUD, the company sees a substantial market opportunity. According to InvestingPro data, Clearmind maintains a healthy balance sheet with more cash than debt, though it remains unprofitable over the last twelve months. Dr. Adi Zuloff-Shani, CEO of Clearmind, expressed optimism about CMND-100’s potential to transform AUD treatment.

The FDA-approved clinical trial will evaluate the safety and efficacy of CMND-100 in reducing alcohol consumption at two prestigious U.S. institutions: Yale School of Medicine’s Department of Psychiatry and Johns Hopkins University School of Medicine. An additional trial will take place at the Israel Medical Center for Addiction in Ramat Gan, Israel.

Clearmind Medicine is committed to addressing widespread health issues with limited current solutions. The company’s intellectual property portfolio includes 19 patent families and 31 granted patents. It aims to commercialize its compounds as regulated medicines, foods, or supplements and continues to seek patent protections and intellectual property acquisitions.

This announcement comes amid the growing acceptance of psychedelic therapies in the medical community. Clearmind’s progress in developing CMND-100 is based on a press release statement and reflects the company’s ongoing efforts to pioneer new treatments for binge behavior and related disorders. However, the company cautions that forward-looking statements involve risks and uncertainties, and there can be no guarantee of future results or achievements.

In other recent news, Clearmind Medicine Inc. has initiated a Phase I/IIa clinical trial to evaluate its novel treatment, CMND-100, for Alcohol Use Disorder (AUD). This trial, conducted in collaboration with the Yale School of Medicine and Johns Hopkins University, aims to assess the safety and potential effectiveness of CMND-100 in reducing alcohol cravings. Furthermore, Clearmind has received Institutional Review Board approval to conduct this trial at Yale, marking a significant step in their FDA-regulated clinical program. In a separate development, Clearmind secured a patent in South Korea for a combination therapy targeting cocaine addiction, using their proprietary MEAI compound. The company also filed a European patent application for a therapy addressing various binge behaviors, in collaboration with SciSparc Ltd. Additionally, Clearmind announced a partnership with Polyrizon Ltd. to develop an intranasal formulation for psychedelic-based treatments. These recent developments underscore Clearmind’s ongoing efforts to expand its intellectual property portfolio and advance its clinical-stage drug candidates.

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