(Part three of a four-part series)
See previous parts of the series:
Next-Generation Psychedelics: The Case Of MEAI And Its Potential To Treat Addiction
Next-Generation Psychedelics, MEAI - How And Why, An Israeli Scientist Explains
MEAI is a potent synthetic molecule essentially developed in the form of a powder.
Nonetheless, for its Alcohol Use Disorder (AUD) study, developer Clearmind Medicine (NASDAQ:CMND) will create a hard-gel capsule so that the clinical trial participants can self-administer the psychedelic.
For the alcohol substitution product, the company is aiming to make MEAI take the shape of a beverage.
Several doses were tested in the preclinical stage so far. "We started from something relatively low -yet what we found to be effective in the other animal studies that we had already performed- and we went up to three times higher and three times lower considering what we found to be the effective dose in animals," CEO Dr. Zuloff-Shani explained.
This, she says, is how New Chemical Entities (NCEs) -just as MEAI- are usually developed.
See also: Psychedelics Biotech Company Raises $39M To Develop Next-Gen Treatment For Depression
The company has not yet publicly shared the effective MEAI dose, but Clearmind's CEO exclusively told Benzinga that what they found to be an effective dose in animal studies is 40 milligrams per kilogram, which translates to something like 400 milligrams on average in a person that weighs 60 kilograms.
Preclinical trials only allow for animal behavior observation. In these, MEAI treatment did not show any symptoms of anxiety or depression in rats, as compared to the control group, but they were "very active and acted quite normally."
MEAI did not appear to be a reward either. The mice had an IV system that allowed them to control the amount of substance they consumed. "When they had this possibility for cocaine, they continuously tried to get more and more, but with MEAI they did not want to get any," Zuloff-Shani explained.
Of course, Clearmind expects these results will hold for humans as well.
An upcoming Phase 1 trial is planned to be conducted in two sites in Israel and the US, following the submission of the IND clinical trial application as well as the Israeli application.
On whether the Israeli regulatory path (and approval) could be somehow faster than the process in the U.S., the answer is it varies. "Usually it is not, as Israel likes to rely on the FDA. But sometimes there are exceptions. When you have a problem like alcoholism, with a huge unmet need and not very effective treatments, it can help," says Zuloff-Shani.
Next Up: Next-Generation Psychedelics, MEAI: The Road Ahead
Photo: Benzinga edit with photo by Raimundo79 and Sergey Nivens on Shutterstock.