The initial discoveries in cannabis research were made in Israel, and the country is proving similarly innovative in the development of psychedelic drugs. One of the most interesting companies in the psychedelics sector is Clearmind Medicine, a public Canadian company with an Israeli subsidiary that leads the R&D activities of the company. The company is traded in Canada, US, and Germany (CMND.CN, CMNDF, CWYO respectively).
Most psychedelics companies develop products based on the same short list of psychedelics molecules: psilocybin, LSD, MDMA and ibogaine. Clearmind has a different strategy: it holds patents for a new psychoactive molecule named MEAI which shows efficiency in early studies on binge behavior and mental health, including alcohol use disorder and binge eating.
MEAI can be described as a “lite” psychedelic which exerts a slightly euphoric alcohol-like experience. For that reason the treatment can be given at home, without the expensive in-clinic protocol.
Clearmind is also developing several other molecules with interesting potential. We met with CEO Adi Zuloff-Shani, PhD, to hear more about the company’s status and plans for the near future.
Q: Adi, how did you get into the psychedelic field? Can you tell us about your personal background?
A: I joined Clearmind because I am excited about the scientific breakthrough of MEAI and its potential to combat challenges such as alcoholism, binge eating, and other binge behaviors. And we are now developing additional programs for other mental health conditions.
At the same time, I’m not the typical CEO in the psychedelic field. I have not much personal experience with recreational drugs or psychedelics. I am a scientist with a PhD in human biology and immunology and more than 20 years of experience navigating the highly regulated process of taking therapeutics from discovery to the market in the US, EU, and Israeli markets.
Q: Can you tell us what MEAI does and what products can be developed with it?
A: MEAI is a new psychedelic compound (5-methoxy- 2-aminoindane) that was first used as a recreational drug , with some irresponsible usership in its early days, that was patented in 2014. Some initial users saw a potential to prevent binge drinking. Clearmind acquired the patents for MEAI and in parallel expanded its intellectual property to 20 separate patents.
We’re now focused on the safe exploration of the compound as a pharmaceutical treatment for alcoholism, and are in conversations with regulatory bodies mostly in the US, to begin clinical trials.
Alcoholism is one of the great illnesses of our time, causing at least 3 million deaths annually around the world. The Covid pandemic only made it worse. And despite this emergency, the only medications available to date have low efficiency and some bring with them adverse side effects such as vomiting, mood disorder, and seizures.
The following is how we see the treatment- Clearmind’s pharmaceutical pill is designed to offer an appealing approach to healing alcoholism: delivering an elated and sociable feeling that typically comes after with 1-2 drinks, while expected to also create a “that’s enough” switch in the brain, preventing overuse. Clearmind’s treatment will be delivered in the form of a pill, similar to the new generation of compounds recently approved by FDA to curb overeating.
Our novel treatment is expected to be non-hallucinogenic, and non-addictive, and can be safely used in conjunction with alcohol.
Q: One of the problems with the financial model of psilocybin and other psychedelics treatment is that it requires long and expensive in-clinic treatments. MEAI can be self-administered, so will it become at-home microdose pills? Is MEAI a Schedule I substance?
A: Patient safety is the most critical aspect of any potential pharmaceutical journey. We are laser-focused on developing a safe and effective treatment in concert with regulatory bodies. That said, Clearmind has already set a strong foundation for R&D and regulatory engagement. We are well underway with preclinical studies, and already in communications with the FDA.
We expect to launch our first clinical trial in late 2022. Our pharmaceutical is intended to be a self-administered pill. In the United States, MEAI has not been officially evaluated for its status as a controlled substance. It is currently unknown how it will be scheduled, and it is not currently found in Schedule I of the U.S. Schedules of Controlled Substances. This molecule also does not exist on the U.S. Toxic Substances Control Act, or Chemical Substance Inventory List. In Canada, Health Canada has stated that MEAI is a controlled substance due to its structure being similar to amphetamines, however at this point in time the molecule MEAI itself is not listed in Schedule 1.
Q: MEAI has an immediate result. Does it mean it can be taken daily for a prolonged period, or is it one-time treatment like other psychedelics?
A: MEAI’s dosage will ultimately be determined by the results of our clinical trials. That said, we expect the pill to be taken regularly during prolonged periods, rather than one-time use.
Q: The first treatment candidate for MEAI is alcohol use disorder. Why did you decide to start with this vertical?
A: Alcohol consumption is an ongoing epidemic with an urgent need for solutions. AUD is responsible for more than 95,000 deaths per year in the US, and 3 million around the world. Despite this impact, there are only three FDA-approved medications for AUD, and abstinence programs such as 12-Step/AA have estimated success rates of 5%-10%.
Even in psychedelics, only 2% of active or completed clinical trials in the sector relate to alcohol issues.
Q: Last November, Clearmind launched a study for binge eating with the Hebrew University. Can you share the goals of that study, or if there are already any initial results?
A: Clearmind sees promise in MEAI potentially innerving neural pathways such as 5-HT1A, which leads to decreased impulsivity and “sensible behavior.” This study was intended to explore this potential. It is too early to share results currently
Q: So, Clearmind has pre-clinical studies in both alcohol use disorder and binge eating. What are the next steps in the clinical program?
A: We are in communications with the FDA. We expect to launch our first clinical trial in late 2022.
Q: Are there additional proprietary treatment candidates?
A: There certainly are but since we have not yet communicated our additional programs with the public, I prefer to discuss this on our next interview
Q: Can you tell us more details on your joint venture with Medigus?
A: Medigus is a proven technology leader with experience developing advanced medical solutions. They’re a great partner to fold into our ecosystem as we advance our go-to-market strategies. We intend to work with Medigus on a joint venture in the food industry, focusing on the product development of novel food and food supplements. We’ll be excited to share more details on our partnership later this year.
Q: The company market cap is about CAD 23 million, which is low relative to other psychedelics companies. Can you understand the gap? Is it because Clearmind is still under the radar for the institutional investors?
A: While our company has quickly built a robust R&D operation and IP portfolio, and advanced preclinical trials, we are still a relatively young company (less than a year) with limited exposure to institutional investment audiences.
We are energized by our potential to grow and help lead the psychedelic market, as the only players to hold sole patents for our compound, ability to deliver immediate results (based on early studies), and the self-administered nature of our treatment.
We expect to share our story and unique value proposition in more detail in the coming year.
Q: Clearmind had CAD 6.6 million in cash. When are we going to see additional funding rounds?
A: We have just announced Medigus’ s 1.6M CAD investment and we expect to participate in additional fundraising rounds later this year.
Q: What are your expectations for Clearmind for the 3-4 next years? When will the stock complete its listing on Nasdaq? Will you consider having Clearmind participate in some kind of an M&A deal?
A: Being listed on Nasdaq is certainly a near or middle-term goal for Clearmind. We are certainly open to a range of potential partnerships, which could include an M&A, though that is not a core focus of ours. Our most urgent focus is to advance clinical trials for our treatment for AUD and get closer to helping as many people as possible.