Exclusive: Clearmind Medicine Secures Approval to Start Clinical Trial for Alcohol Dependence Treatment – Clearmind Medicine (NASDAQ:CMND)


Clearmind Medicine Co., Ltd. CMND, an Israeli biotech company, has received approval from the IMCA Center’s Ethics Committee for its announced Phase 1/2 clinical trial evaluating its proprietary MEAI-based compound CMND-100 for the treatment of alcohol use disorders (AUD). Got approval. ) Clearmind is discovering and developing novel psychedelic-derived treatments for major undertreated health problems.

The Ethics Committee of the IMCA Center (equivalent to the U.S. Institutional Review Board in Europe and Israel) operates under the regulations of the Declaration of Helsinki and other international treaties on medical experimentation on the human body, and is responsible for medical research involving the human body. Research and clinical trials need to be authorized, reviewed and monitored. subjects.

The committee reviews research protocols and related materials (such as informed consent documents and researcher brochures) to ensure that the rights and welfare of participants are protected.

“The approval of the study by the ethics committee is an important step forward in initiating first-in-human clinical trials of CMND-100,” said the company’s CEO. Dr. Adi Zurof Shaniadded that CMND-100 was shown to cause significant and immediate reductions in alcohol cravings and alcohol consumption in preclinical studies with a high safety profile.

Clearmind therefore also considers that the drug is designed as a once-daily oral capsule that can be taken at home, suggesting that the drug may have “great potential” as an alternative to current approaches. I believe there is.

“With CMND-100, we aim to revolutionize AUD treatment and improve patient treatment compliance compared to other marketed pharmacotherapies,” concluded Dr. Zurov Shani.

Upcoming CM-CMND-001 is a multinational, multicenter study of single and multiple dose tolerability, safety and pharmacokinetics of CMND-100 in both healthy volunteers and AUD subjects .

Additionally, this trial will also aim to assess the efficacy of novel compounds in reducing drinking patterns and cravings in individuals with moderate to severe AUD.

Oral capsules are administered once daily for 10 consecutive days. Participants will report drinking patterns and alcohol (and tobacco) cravings during the trial period.

For the time being, the research will be led by Dr. Mark Weiser, Director of Psychiatry at Shiva Medical Center in Ramat Gan, Tel Aviv. Clearmind will acquire two more locations in the United States, subject to the signing of agreements with local facilities.

Photo by Benzinga, edited by Raimundo79 and Sergey Nivens on Shutterstock.



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