Published at Cannabis Tech.
If the 2020 US election demonstrated anything, it's the growing appetite for natural medicines like cannabis and fungi. The fact that Oregon's legalization of psychedelic mushrooms received more positive media attention than most other than any other state ballot measures voted on during the election says a lot about the direction Americans want to go in the coming years.
Riding this wave of excitement, Gennifer Murray sat down with Damon Michaels, Founder and Chief Operating Officer of Mydecine, to discuss a new approach to nature-sourced medicines through a pharmaceutical lens.
The Wild West environment many remember from the early years of weed are now replaying among psychedelics. Even so, psychedelic and mushroom medicines seem to be moving much more quickly than cannabis ever did. Michaels and the team at Mydecine aim to lay a solid, methodical, and thoughtful foundation for robust research and development — and one which importantly paves the way for a "breakthrough" ruling by the Food and Drug Administration (FDA).
Clearly, cannabis has helped lay the foundation for this new wave of psychedelic and fungi-based medicines. There is now a new wave of legal allowances for psychedelics in the same spaces where legal cannabis first broke ground (California, Colorado, and Oregon, among others).
Michaels himself came from the cannabis sector. During his time at ebbu Inc., an Evergreen, Colorado-based hemp research leader, he was introduced to a thoroughly scientific approach to plant-based medicines.
ebbu Inc. had made a name for itself within the industry by applying cutting-edge scientific techniques to cannabinoid medicine. At ebbu, Michaels worked with the team to "utilize true science and develop the pharmacology" of the plant. The end goal was "road-mapping the entourage effects of cannabis to make it applicable for unique medicine and personalized medicine." By the time the company sold to Canopy in 2018, ebbu Inc. had 48 patents and a world-class R&D team.
Now, following the launch of Mydecine in early 2020, Michaels is traveling a similar path. His new company is working to develop fungal-sourced compounds through rigorous R&D. Over the last year, Mydecine has been laying the foundations through several key acquisitions and partnerships and releasing a digital health component to complement any pharmaceutical formulations.
Although psilocybin, just like cannabis, does have the potential to be both a recreational and a medicinal compound, Michael confirms that "Mydecine has no interest in going into adult-use or recreational markets at all." As he tells Murray, "Our focus is the therapeutic pharmaceutical area," but "we are not trying to turn this into big pharmaceutical."
Psilocybin and other federally regulated substances derived from fungi are incredibly challenging (if not prohibitive) to study. The few research centers currently studying psilocybin, like Johns Hopkins University School of Medicine, work almost exclusively with synthetic psilocybin. Michaels confirms this costs upwards of $7,000 to $10,000 per gram, and getting the licensing to work with psychedelics in a lab takes years of bureaucratic and regulatory navigation.
This is why Mydecine is so perfectly situated within the exploding field of fungi-focused biopharma companies. Its recent Applied Pharmaceutical Innovation Agreement with the University of Alberta's Faculty of Pharmacy and Pharmaceutical Sciences means it is one of the only companies with access to a cGMP-certified laboratory. This agreement gives Mydecine the ability to import, export, extract, and analyze psychedelic drugs with full government approval. With this agreement, Mydecine may legally import psilocybin mushrooms from Jamaica for extraction and analysis in Canada.
Michaels is firm in his convictions about medicinal fungi's power to improve the current approach to mental health treatment. The focus of Mydecine is to develop and eventually produce "adaptive pathway medicine" sourced from fungi, complimented by digital health solutions to make it accessible.
To this end, it is currently working on the international expansion of Phase 2A clinical trials of psilocybin-assisted psychotherapy targeting post-traumatic stress disorder among veterans, frontline workers, and EMS personnel. As per a November press release, "The purpose of these trials will be to explore how the brain responds to psychedelics and develop a better understanding of the biological underpinnings created by the psychedelic experience." The goal? Mydecine hopes to "build upon the body of work that has led to psilocybin-assisted psychotherapy to receive "breakthrough" status by the FDA."
While this is by no means the only psilocybin-based clinical trial underway, their strategic partnerships and positioning over the last year have them uniquely placed to execute any scientific and medical discoveries. They have the ability to source, study, analyze, formulate, and launch personalized therapeutic solutions.
According to Michaels, Mydecine has a three-pronged approach to pushing the needle forward on the psychedelic and medicinal fungi research.
Up first: clinical trials, a pivotal piece for proving the worth of this ancient medicine through a modern scientific understanding. Second: the ongoing R&D is aiming to build a robust portfolio of intellectual property covering formulations and delivery methods. Finally, the complimentary piece is MindLeap, a digital wellbeing application. MindLeap is a way to bring it all together, combine technology with psychedelic, research-based solutions for mental health — and make it accessible.
Among the dozens of (or more) companies riding the wave of excitement about psychedelics, Mydecine is one of the few with a transparent and organized plan for getting nature-based solutions to market. Michaels is clear that the company isn't playing the "big game of poker" like what is playing out in the rest of the sector. As he told Murray, "We are playing in our court, with what we have, and what we can do." Most importantly, they are showing their cards and starting with a strong vertically integrated structure.
Listen to the full interview here or wherever you get your favorite podcasts!