Oct 13, 2020
How Numinus plans to support psychedelic assisted psychotherapy access to Canadians and beyond
- Psychedelic-assisted psychotherapy is gaining traction in the medical community with many researchers demonstrating its remarkable clinical effectiveness
- Numinus recognizes the possibilities of psychedelic-assisted therapy and has positioned itself across the value chain as a future potential supplier, scientific leader and clinical service provider
- They are the first public company approved by Health Canada to grow, and extract psilocybin from psychedelic mushrooms and they hold a licence to test, possess, buy and sell MDMA, psilocybin, psilocin, DMT, and mescaline
Canada faces a losing battle against a $51 billion problem every single year—that is the annual cost of lost productivity due to mental illness and addiction. What was once considered the tragedy of an individual and their family is now a ubiquitous problem within the country, as evidenced by the fact that, by the age of 40, about 50 per cent of the population will have experience with mental illness.
— Dr. Evan Wood, MD, PhD, Chief Medical Officer, Numinus Wellness Inc.
“In addition to PTSD and depression, there is a long history of studying psychedelic assisted psychotherapy as an adjunct to the treatment of various addictive disorders.”
It’s time to modernize our approach to mental health and addiction
Canada’s appetite for innovation in mental healthcare is growing and with it comes a renewed interest in a once overlooked group of possible treatments: psychedelic medications. Years ago, scientists had documented tremendous potential in psychedelics such as LSD, MDMA and psilocybin, when applied in combination with a carefully defined psychotherapeutic protocol, in the treatment of alcoholism and various mental health conditions before this class of drugs was banned globally in the late 1960s.
Despite the historical legal ban, research has continued through programs that have allowed the sourcing and use of psychedelics in controlled clinical trials in many of the most prestigious academic institutions, and the research continues to show great promise.
In the International Journal of Neuropsychopharmacology’s article entitled, “Reviewing the Potential of Psychedelics for the Treatment of PTSD,” the authors note that psychedelics like psilocybin have been referred to as promising potential treatments to help those suffering with post-traumatic stress disorder (PTSD). The Journal of Psychopharmacology adds to this and explains how cancer patients dealing with psychiatric distress can potentially benefit from psychedelics as well.
The journal’s article entitled, “Long-term follow-up of psilocybin-assisted psychotherapy for psychiatric and existential distress in patients with life-threatening cancer,” suggested that “Psilocybin-assisted psychotherapy holds promise in promoting long-term relief from cancer-related psychiatric distress.”
Despite the need for continuous studies on the effects of psychedelics, the authors of the article note that their study “Adds to the emerging literature base suggesting that psilocybin-facilitated therapy may enhance the psychological, emotional, and spiritual well-being of patients with life-threatening cancer.”
Moreover, there are programs in place that facilitate patient access and allow healthcare providers and researchers to gather further data on psychedelic assisted psychotherapy. In the American context, the Expanded Access programs enable healthcare providers to apply for access to products and therapies that are banned or unapproved by the FDA. The Multidisciplinary Association for Psychedelic Studies (MAPS) is implementing a protocol under this program to expand market access for MDMA-assisted psychotherapy while in stage 3 trials with the FDA.
In Canada, Health Canada’s preferred means for patients to access drugs that are not yet available on the market is through Compassionate Access, open-label studies that are incorporated into drug development planning to “Meet the needs of patients who are not eligible for enrollment in other pivotal trials.”
Facilitating psychedelic-assisted psychotherapy with Numinus Wellness
One promising industry leader is Numinus Wellness Inc. (TSXV: NUMI), a health and wellness provider focused on developing a cohesive psychedelic-assisted psychotherapy approach by being vertically integrated in every component of the value chain. Numinus’s approach is founded on three pillars: The production, research and distribution of psilocybin extracts as a supplier, R&D into new therapies, and the delivery of therapy through a series of clinics and online platforms.
Numinus is one of the only publicly traded companies to gain approval from Health Canada to extract psilocybin from mushrooms. They have already begun cultivating Psilocybe mushrooms within their lab—a major milestone that allows them to move swiftly in delivering their multifaceted approach bringing psychedelic psychotherapy innovations to the mental health care space.
With access to their own supply of Psilocybe mushrooms, Numinus has fine-tuned access and control when extracting natural psilocybin, a key differentiator for their approach to wellness.
As Numinus CEO and Founder, Payton Nyquvest, puts it, “We’ll have the opportunity to not only extract psilocybin, but also to cultivate and study other compounds found in the ‘magic mushroom’ fungus. We intend to prove a theory similar to the entourage effect in cannabis, in which THC is complemented by various cannabinoids and terpenes for increased therapeutic effect.”
He adds, “So, in this case psilocybin could be complemented by other compounds in mushrooms and may offer untold health benefits and therapeutic opportunities.”
While synthetic psilocybin is used in current clinical trials, Nyquvest notes that there is already research demand for naturally occurring psilocybin and whole fungi naturally extracted compounds to compare therapeutic effects.
Through its Health Canada license and its implementation science research strategy, Numinus has the opportunity to set norms for staff training, develop protocols for therapy delivery, contribute to post-research market standards and provide access to psilocybin extracts to the larger psychedelic-therapy industry. They will also be the first to develop supportive programs around these comprehensive treatments, including post-treatment opportunities and digital wellness platforms.
Part of Numinus’s leadership in the space comes from their facilities. Developing safe and evidence-based psychedelic-assisted psychotherapies is complex. Even with stellar staff and a steady supply of materials, high-end facilities are always needed to conduct quality research. Numinus has positioned itself well by operating a 7,000 square-foot state-of-the-art laboratory staffed by PhD scientists.
A vertically integrated approach to wellness
The laboratory is the epicentre of Numinus’s operations, allowing them to test, import, possess and export a number of psychedelics including psilocybin and MDMA. Further upgrades are already in the works to make the facility GMP compliant to facilitate clinical research.
Specialized clinical spaces also play a critical role in delivering effective psychedelic psychotherapies. To address this, Numinus is building out a clinic specifically designed to administer psychedelic-assisted therapies that is being beta-tested through a range of research projects. These laboratories and clinics, coupled with plans to acquire existing facilities in North America, create the underpinnings of an ambitious therapy model that is fully integrated from supply sourcing to research and patient care.
With the foundational elements of the company established, the roadmap to market leadership is focused on rapid advancement on strategic research partnerships with leaders in the development of MDMA and psilocybin assisted psychotherapy. Strong partnerships are already in place with leading research organizations as well as with Together We Can, one of the largest addiction treatment organizations in the country.
The company’s Chief Medical Officer, Dr. Wood, and Medical Director, Dr. Devon Christie, have already put together a clinical advisory council that includes world-class physicians and healthcare providers, including renowned addiction specialist, Dr. Gabor Maté.
Assembling a clinical advisory council was a crucial decision for the company in order to develop Numinus’s programs, enhance knowledge, and drive policy change in the psychedelic assisted therapy space. As Dr. Wood explains, “In addition to PTSD and depression, there is a long history of studying psychedelic assisted psychotherapy as an adjunct to the treatment of various addictive disorders including the work with alcohol addiction in the United Kingdom and New York University, as well as tobacco addiction at Johns Hopkins University in Baltimore.”
“To date, research from these centres has demonstrated the tremendous potential of psychedelic-assisted psychotherapy to help individuals make positive changes in the context of a range of mental health and wellness challenges.”
Modern facilities, strong research relationships and regulatory approvals have put Numinus in a position to be first-to-market when access to markets opens up. Even with tight access to markets, Numinus’ estimated revenues from testing and research facilities for 2020 stand at $3 million, with major contributions coming from established B2B cannabis testing operations.
Amidst all these exciting developments, it is important to remember the ultimate purpose of psychedelic-assisted therapy: Addressing and treating mental illness and promoting optimal wellness. Bridging the chasm between research and delivering therapy is daunting, but for companies that can successfully do so, there is both economic and social good to be gained.
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Numinus is listed on the TSXV under the ticker NUMI.