- Clearmind (CMND) received approval for its CMND-100 compound to treat alcohol use disorder at Israel’s IMCA center
- The approval was granted by the Ethics Committee for its MEAI-based CM-CMND-001 Phase I/II clinical trial
- CM-CMND-001 is a multinational, multi-center, single and multiple dose tolerability, safety, and pharmacokinetic Study of CMND-100 in healthy volunteers and AUD subjects
- Clearmind Medicine Inc. (CMND) opened trading at $0.78 per share
Clearmind (CMND) received approval for its CMND-100 compound to treat alcohol use disorder at Israel’s IMCA center.
The approval was granted by the Ethics Committee for its MEAI-based CM-CMND-001 Phase I/II clinical trial.
CM-CMND-001 is a multinational, multi-center, single and multiple dose tolerability, safety, and pharmacokinetic Study of CMND-100 in healthy volunteers and AUD subjects.
The primary end point of the trial is to find the tolerable dose and characterize the safety and effectiveness single and repeated doses of CMND-100 in healthy subjects and those with alcohol use disorder.
The secondary end point is to preliminarily evaluate the efficacy of CMND-100 in reduction of drinking patterns and craving in individuals with moderate-to-severe alcohol use disorder. Oral capsules will be administered once daily, for 10 consecutive days.
Clearmind’s Chief Executive Officer, Dr. Adi Zuloff-Shani called Ethics Committee approval of the study marks a key step forward in beginning the first-in-human clinical trial of CMND-100.
“According to Research Nester, the alcohol treatment market is estimated to be US$35 billion per year market in the U.S. alone, where the estimated number of people diagnosed with AUD total approximately 35 million people each year. Despite a significant addressable market and the fact AUD is a leading cause of death, current therapies often fall short due to limited efficacy, relapse rates, side effects and other factors. CMND-100 was shown to cause a significant and immediate reduction of alcohol cravings and consumption in pre-clinical studies with a high safety profile. As a result, we believe that CMND-001 holds tremendous potential as an alternative to current approaches.”
The Ethics Committee is the European and Israeli equivalent of the Institutional Review Board (IRB)), of the IMCA center and is designated to authorize, review, and monitor medical research and trials involving human subjects.
Clearmind is a psychedelic pharmaceutical biotech company. Its objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods, or supplements.
Clearmind Medicine Inc. (CMND) opened trading at $0.78 per share.
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