- Clearmind Medicine has received approval from the Ministry of Health of Israel to begin its phase I/IIa clinical trial for alcohol use disorder
- The trial will use the company’s proprietary MEAI-based CMND-100 oral capsule in patients with AUD
- The clinical trial is a single and multiple-dose tolerability, safety and pharmacokinetic study of CMND-100 in healthy volunteers and AUD subjects
- Shares of Clearmind Medicine are down 3.64 per cent C$2.38 as of 10:34 am ET
Clearmind Medicine (CSE:CMND) is gearing up to begin its phase I/IIa clinical trial for alcohol use disorder (AUD) after approval from the Ministry of Health of Israel.
In a news release, the company stated the trial will use its proprietary MEAI-based CMND-100 oral capsule in patients with AUD.
Additionally, the trial is a single- and multiple-dose tolerability, safety and pharmacokinetic study of CMND-100 in healthy volunteers and AUD subjects.
The trial’s primary endpoint is finding a tolerable dose and characterizing the safety and pharmacokinetics/pharmacodynamics of single and repeated doses of CMND-100 in healthy subjects and those with AUD.
The secondary endpoint is to evaluate the preliminary efficacy of CMND-100 in the reduction of drinking patterns and cravings in individuals with moderate-to-severe AUD.
“We are thrilled to receive approval to commence our phase I/IIa clinical trial for our lead drug candidate, CMND-100, which has been shown to be safe and effective in preclinical studies. This is the most important milestone for the company to date and marks our transition to a clinical-stage pharmaceutical company,” Adi Zuloff-Shani, CEO of Clearmind Medicine, said in a statement. “Our non-hallucinogenic, psychedelic solution could be the answer to the tremendous global need for groundbreaking, dedicated and effective treatments for addictions.”
In addition to the clinical trial site in Israel, Clearmind Medicine anticipates having two additional sites in the United States, notably the Yale School of Medicine’s Department of Psychiatry and the Johns Hopkins University School of Medicine.
Clearmind is a psychedelic pharmaceutical biotech company focused on novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder.
Shares of Clearmind Medicine are down 3.64 per cent C$2.38 as of 10:34 am ET.
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