EXCLUSIVE: Clearmind Medicine Secures Approval To Launch Clinical Trial For Alcohol Addiction Treatment

Clearmind Medicine Inc. CMND, an Israeli biotech company received approval from the IMCA center’s Ethics Committee for the announced Phase 1/2 clinical trial assessing its proprietary MEAI-based compound, CMND-100, for the treatment of Alcohol Use Disorder (AUD.) Clearmind discovers and develops novel psychedelic-derived therapeutics for major undertreated health problems.

The Ethics Committee -the European and Israeli equivalent of the IRB in the U.S.- of the IMCA center, operating under the Declaration of Helsinki regulations and other international conventions around medical experiments on humans, must authorize, review and monitor medical research and trials involving human subjects. 

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

“Ethics Committee approval of the study marks a key step forward in beginning the first-in-human clinical trial of CMND-100," stated the company’s CEO Dr. Adi Zuloff-Shani, adding that CMND-100 was shown to cause a significant and immediate reduction of alcohol cravings and consumption in preclinical studies with a high safety profile. 

This has led Clearmind to believe the drug could hold “tremendous potential” as an alternative to current approaches, also considering it is designed as a once-a-day oral capsule that can be taken at home. 

“With CMND-100, we aim to revolutionize AUD treatment and improve patients’ compliance to therapy compared to other marketed pharmacotherapies,”  Zuloff-Shani concluded. 

The upcoming CM-CMND-001 is a multinational, multi-center, single and multiple dose tolerability, safety and pharmacokinetic study of CMND-100 in both healthy volunteers and AUD subjects. 

Additionally, the trial will seek to evaluate the efficacy of the novel compound in the reduction of drinking patterns and cravings in individuals with moderate to severe AUD. 

Oral capsules will be administered once a day for ten consecutive days. Participants will report their drinking patterns and craving for alcohol (and cigarettes) during the trial period. 

For the time being, the study will be led by Dr. Mark Weiser, head of the Psychiatric Division at the Sheba Medical Center located in Ramat Gan, Tel Aviv. Clearmind intends to obtain two additional sites in the U.S., subject to entering agreements with local facilities.

Photo: Benzinga edit with photo by Raimundo79 and Sergey Nivens on Shutterstock.

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