(Part four 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
Next-Generation Psychedelics, MEAI - What And When
Clearmind Medicine (NASDAQ:CMND)'s CEO Dr. Adi Zuloff-Shani has said that she believes MEAI can potentially be consumed on a regular basis over time.
"I can't say now if it'll be for several months, for a year or for a lifetime, but certainly for a few months," Zuloff-Shani told Benzinga.
This is unusual in psychedelics treatment and could constitute a positive market prediction combined with the company's expansive IP protection.
In the specific case of MEAI as an alcohol substitute, Clearmind seems to be the company with the most advanced product.
Clearmind's regulatory advisor Nick Kadysh told Benzinga that the burden of alcoholism in the public health system is "remarkably damaging," whether the burden relies on people or on the government.
As such, this constitutes an "incredible market opportunity," he said, for both the treatment of Alcohol Use Disorder (AUD) and for the development of a safer alcohol substitute, which "has been a dream of harm reduction for a very long time."
The company views the fact that MEAI has not been shown to provoke hallucinogenic effects, as observed in animals and concluded on human testimonials, could potentially ease its approval process.
What this property also entails is that it is not the type of assisted therapy that os often necessary with psilocybin or MDMA, in which a therapist or facilitator accompanies the patient throughout the treatment given that the psychedelic's potent effect requires a psychotherapeutic framework.
In terms of regulatory applications, one of the several paths a company can take to make their psychedelic drug product advance faster and potentially reach the commercialization stage is the "Breakthrough Therapy" designation.
Asked whether Clearmind will consider utilizing it for the treatment of AUD, Zuloff-Shani CEO told Benzinga that she definitely hopes so.
"But in order to get through this process, you have to have some initial results, something that you can say that you have a breakthrough therapy, and therefore you can get those acceleration programs. I do hope that after this Phase 1 –we actually hope to do a Phase 1/2 together-, from the results we will obtain in the study we will be able to go to one of those accelerated programs," she said.
As the sole developer of MEAI therapy, it is the task of Clearmind to demonstrate that these initial results are safe and effective.
Photo: Benzinga edit with photo by Raimundo79 and Sergey Nivens on Shutterstock.