Clearmind Medicine Inc. (Nasdaq, CSE: CMND), (FSE: CWY) has received ethics approval to begin clinical trials of an experimental alcohol use disorder drug treatment at an Israeli medical center.
The Vancouver-based biotechnology company announced May 12 that the ethics committee of IMCA Medical Center approved a Phase 1 and 2 clinical trial of Clearmind’s proprietary CMND-100 compound. The open-label trial will determine a maximum tolerated dose and evaluate the safety, pharmacokinetics and potential efficacy of the treatment.
Clearmind aims to enroll 30 to 50 subjects with moderate to severe alcohol use disorder to take CMND-100 orally for 10 days at three sites, including IMCA and two still-to-be-determined locations in the United States. The primary goal is to assess the safety and appropriate dosage of the treatment, but researchers will also examine whether it can curb cravings and drinking.
“Ethics Committee approval of the study marks a key step forward in beginning the first-in-human clinical trial of CMND-100,” Clearmind chief executive officer Dr. Adi Zuloff-Shani said in a statement. “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.”
Company stock grew by 25.6 per cent on Friday to $0.98 on the Canadian Securities Exchange.
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Alcohol use disorder is estimated to affect some 35 million people in the United States alone, representing a $35-billion potential treatment market. However, current treatment options are limited by uneven efficacy, high relapse rates, side effects and poor compliance. CMND-100 aims to provide a more effective and patient-friendly alternative as an oral once-daily capsule.
Clearmind is focused on developing psychedelic-derived treatments for alcohol use disorder and other underserved health conditions. The company has a portfolio of 14 patent families and intends to seek more intellectual property protection as it advances other promising compounds.
The trial still requires regulatory approval in the countries where it will be conducted before enrolling patients. If successful, further trials would be needed to verify the results and determine CMND-100’s suitability for commercial use. Still, the ethics committee’s clearance represents an important initial approval to move forward with testing the novel treatment.
Natalia@mugglehead.com
