- Clearmind (CMND) has submitted an investigational new drug application with the U.S. Food and Drug Administration
- The application requests approval to initiate its first-in-human Phase I/IIa clinical trial with CMND-100 in patients suffering from alcohol use disorder
- Pending regulatory approval, the company plans to initiate the CMND-100 trial in Q2 2023
- Clearmind Medicine Inc. (CMND) opened trading at C$4.93 per share
Clearmind (CMND) has submitted an investigational new drug application with the U.S. Food and Drug Administration (FDA).
The application requests approval to initiate its first-in-human Phase I/IIa clinical trial with CMND-100 in patients suffering from alcohol use disorder (AUD). Pending regulatory approval, the company plans to initiate the CMND-100 trial in Q2 2023.
The active ingredient in CMND-100 is MEAI (5-methoxy-2-aminoindane), a novel psychoactive molecule that has been reported to reduce the desire to consume alcoholic beverages while exerting a euphoric alcohol-like experience. MEAI was found to interact with the serotonergic receptors, which play a key role in the regulation of alcohol intake, reward, preference, and dependence.
Clearmind’s CEO, Dr. Adi Zuloff-Shani, Ph.D. explained that from studies with MEAI, the team believes it has potential to break the vicious drinking cycle at the point of the decision to drink more alcohol, by potentially innervating neural pathways that lead to sensible behavior.
“Globally, AUD causes many billions of dollars in healthcare costs and millions of deaths each year. The IND submission to FDA, to initiate our clinical trial, is a milestone showing the huge commitment of the Clearmind team to finding a solution to this abusive disorder. We’re thrilled to be a step closer to helping patients with severely unmet medical needs.”
According to the National Survey On Drug Use And Health, almost 28 million people over 18 years of age struggled with alcohol use in the U.S. alone in 2020.
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 C$4.93 per share.
