Psyched Wellness (CSE:PSYC, OTCQB:PSYCF) Corp is on track to become the first company to market Amanita muscaria for human consumption.
Derived from mushrooms, Amanita muscaria, or fly agaric, is instantly recognizable thanks to its distinctive red cap with white specks. Old school Nintendo players will know it as the mushroom that Mario catches to turn him into Super Mario, giving the character the ability to smash through bricks and take hits from enemies.
Does it do the same for humans? Well, not exactly. Amanita muscaria, if consumed improperly, can be quite unpleasant and even lead to an emergency room visit due to one of the main compounds, ibotenic acid. In order to avoid this, one needs to create an extract from the mushroom by decarboxylating the mushrooms which converts the ibotenic acid into muscimol. Muscimol is the compound that provides the desired effects.
That hasn’t stopped humans from consuming it for centuries. When micro-dosed, Amanita muscaria can soothe the body, ease physical distress and help with sleeping. If harnessed correctly under the right conditions, the compound could become a promising health and wellness supplement.
Enter Psyched Wellness (CSE:PSYC, OTCQB:PSYCF). While other companies are racing to study and market the more popular psychedelics, like psilocybin or LSD, Toronto-based Psyched is placing its bets on Amanita muscaria.
The team is led by CEO Jeff Stevens and guided by the stewardship of board member Professor David Nutt, a pioneer in the field of psychedelic medicine and one of the first researchers to look at Amanita muscaria. Psyched works with contract research organization KGK Science, which runs its preclinical studies with the goal to position the firm to apply to the FDA and Health Canada for natural health products designation.
In an exclusive interview with Proactive, Stevens shares the benefits of the psychedelic and how the company is making it safe for consumption.
Proactive: We’ve heard so much about psychedelics over the past couple of years, but Psyched is one of, if not the only, company focused on Amanita muscaria. Why have you chosen to focus on this rather than, say, psilocybin?
Jeff Stevens (JS): That’s a great question. When you first look at this compound, and you're doing your research, it shows up in a Google search as poisonous. I think many people got turned off by that. We took the opportunity to do toxicology assessments and determine if we could actually work with muscimol extract in a safe way for human consumption and determined that yes, we could. For us, it’s just a matter of rolling up our sleeves and doing the heavy lifting early. My sense is that there's a number of companies waiting in the wings for us to complete preclinical trials so that there is the safety and efficacy data in the market, and then you'll start to see other people come to market with Amanita muscaria-derived products.
We’re going after the health supplement market. Because we're the first company to do this work, we're doing the full workup. We are two-thirds of the way complete on our preclinical studies which will position us to file an application to the FDA (US Food & Drug Administration) for a New Dietary Ingredient (NDI) with the goal of getting a health and wellness product to market where we can start building a brand and generating revenue to help offset the costs of further research and development.
Why have you decided to market Amanita muscaria as a natural health product, rather than a pharmaceutical drug?
Amanita muscaria has never been a scheduled drug, meaning it isn’t regulated by the US Drug Enforcement Administration (DEA), instead, it is treated as a food and we are able to work with it under those much less restricted guidelines. In addition, we have centuries of human use ranging from the Siberian Shamans use for ceremonial purposes to more recent anecdotal use of Amanita Muscaria for health and wellness issues. All of this goes to support our application to the FDA and Health Canada as a supplement. Because of this, we feel like we have a unique opportunity with this compound versus our peers who don't have the ability to get to market with a functional psychedelic mushroom product.
Is there a chance that the regulators responsible might not agree with that classification?
We are not putting a psychedelic product in the market, our products will be wellness products We’re doing everything within the guidelines, working closely with KGK, who have regulatory staff to ensure we meet the requirements. The path to market that KGK provided for us is set up specifically so that we will check all the boxes when we make our applications.
Can you update us on the progress being made on the research and development front?
We're halfway through our 90-day oral toxicity study, which is a key study for us to give us a sustainable dose level. We’ve also initiated the first steps towards a clinical sleep study, which will be led by Professor David Nutt. Once we complete our preclinical work, that provides us with the data that we need for determining dosage, shelf life, expectations, etcetera.
How close are you to getting Amanita muscaria into stores, and what does that entail?
4Q is exciting for us because we are aiming to complete those preclinical studies and then move forward to making our applications. We will be filing our pre-submission meetings with the FDA and Health Canada. The idea is that when those approvals are met, we'll be ready to start testing the product and get it to market in the US and Canada.
At the same time, we’re looking at other studies that we can do. There are so many opportunities with (Amanita) when it comes to mental and physical (health). I think we're in the first innings of the game and there’s a lot of runway in front of us. I believe that companies with good leadership, a solid plan, and a strong cash position will be the ones that survive and lead the industry. Psyched Wellness checks all the boxes in that respect.
Contact Angela at angela@proactiveinvestors.com
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