- Numinus is the first Canadian public company to legally grow and harvest psilocybin mushrooms
- The company has also partnered with the Multidisciplinary Association for Psychedelic Studies (MAPS) on a clinical trial of MDMA for PTSD, now in the pre-implementation stage
- These milestones represent a shift towards greater patient access to psychedelic therapy, and the development of infrastructure to deliver it safely
Mental illness and addiction are a global epidemic — and our current mental health systems are failing. With 1 in 5 Canadians suffering from addiction, 1 in 11 experiencing post-traumatic stress disorder (PTSD) in their lifetime and 971 million people globally suffering from a mental or substance use disorder, it’s clear that current treatments are not meeting patient needs.
"While there is a place for synthetic psilocybin in clinical practice, well-characterized and standardized extracts of natural forms of psilocybin are the wave of the future,”
— Dennis McKenna, leading Ethnopharmacologist and member of General Advisory Council, Numinus Wellness Inc.
Many mental health treatments focus on medications that have limited benefits, poor uptake, and require chronic use, not to mention being associated with increased mortality and over 80,000 emergency room visits each year in the United States alone.
Psychedelic-assisted psychotherapies have emerged as a long-overdue innovation in this sector. Once stigmatized and heavily restricted, these substances, such as psilocybin mushrooms and MDMA, are gaining mainstream acceptance for their exceptional promise.
For instance, 2020 saw Health Canada approve psilocybin therapy for select patients with terminal illness, followed by regulatory revision to allow some controlled access to psychedelics outside of clinical trials.
An industry first
Leading the way for psychedelic-assisted psychotherapy in Canada is Numinus Wellness Inc. (TSXV: NUMI), a company that has just taken an exciting step forward by becoming the first Canadian public company to legally grow and harvest psilocybe mushrooms.
The company’s Health Canada-licensed lab can legally work with a range of psychedelic substances including psilocybin, MDMA, and DMT, placing it at the forefront of psychedelic research in Canada.
Beyond representing a major milestone for Numinus, the harvest signals a changing tide for mental health and addiction treatment in Canada. Michael Tan, Numinus’s Chief Operating Officer, thinks its implications will be wide-ranging. “Now, we can progress with research and development to support safe, evidence-based, accessible psychedelic-assisted psychotherapy, as well as build a sequenced spore library,” he says.
Payton Nyquevest, CEO of Numinus, is similarly optimistic about the future of both the company, and psychedelic-assisted psychotherapy in Canada. “The legal harvest gives us a first mover market advantage,” he notes, “But I'll venture to say that it signals an overall loosening of restrictions, and serious consideration by regulators.”
Significantly, the capability to legally grow and harvest psilocybe mushrooms will allow Numinus to pursue treatments based on natural psilocybin extracts, rather than synthetic forms of this compound.
"While there is a place for synthetic psilocybin in clinical practice, well-characterized and standardized extracts of natural forms of psilocybin are the wave of the future,” says Dennis McKenna, leading Ethnopharmacologist and member of Numinus’s General Advisory Council.
“Given a choice, many people would prefer the option to use natural psilocybin. Natural mushroom extracts are also likely to be far more affordable, an important consideration when it comes to ensuring accessibility.”
A PTSD treatment breakthrough
Another major development is Numinus’s progress towards Canada’s first compassionate access clinical trial of MDMA-assisted therapy for PTSD. The single-arm, open-label trial is a collaboration with MAPS Public Benefit Corporation, a leader in research and treatment into psychedelic therapies.
The trial, which is now in the pre-implementation stage, is the first of its kind in Canada. It represents the culmination of many years of hard work to bring MDMA-assisted therapy to PTSD patients, for whom other treatment options are extremely limited. As MDMA therapy moves closer to the mainstream, trained and qualified medical staff, like therapists and physicians, will be crucial to implementing it safely.
To that end, Numinus’s MAPS Public Benefit Corporation (PBC) partnership includes the recruitment of therapists to undergo MAPS’ specialized training program. So far, eight therapists have been trained, representing a growing cohort qualified to push this new model of mental health treatment forward, both carrying out clinical therapeutic trials and collecting data on patient outcomes.
"Developing a skilled workforce is a key challenge for the safe delivery of psychedelic-assisted therapies, so we are pleased to engage with Numinus to train therapists in the MDMA-assisted therapy protocol for PTSD,” says Amy Emerson, CEO of MAPS PBC.
“There is a lack of qualified practitioners to provide psychedelic-assisted psychotherapy. We're going to work with MAPS to change that,” explains Nyquvest. “MAPS are a group that's been doing the legwork in this space for many decades. Their agreement to partner with us on this MDMA trial was the green flag that they saw we were working in the right way and continuing to do so.”
We've reached key milestones in our compassionate access trial of #MDMA-assisted #psychotherapy for #PTSD in collaboration with MAPS PBC. Now in pre-implementation, we are advancing towards expanded access for patients in need. Full release here ⬇️ $NUMI— Numinus (@NuminusInc) February 18, 2021
Massive need and room for growth
The lack of innovative treatment options for mental, neurological and substance use disorders isn’t just a crisis of compassionate healing; it’s an enormous market opportunity. With $2.5 to $8.5 trillion in economic output lost every year to these conditions, the total addressable market for mental health is estimated at over $100 billion globally.
As a well-funded, revenue-generating company backed by rigorous research, development, treatment and testing, Numinus is poised to dominate this space in Canada. The company’s bioscience lab has been operational for nearly a decade, making it exceptionally well-established in this young sector.
Indicative of the company’s strong reputation is its financing; over the course of the past year, Numinus has built cash on hand of nearly $70 million to drive its mission forward. Company financings have been complemented by the company’s revenue-generating activity in the cannabis sector.
Numinus’s integrated model also sets it apart, enabling the Company to develop, test and deliver treatment options all within the framework of their subsidiaries. These are Numinus Bioscience, where new therapeutics and treatment methods are developed in their Health Canada-licensed lab; Numinus Research and Development, where clinical and therapeutic protocols are developed together with partners and regulators; and Numinus Health, which delivers treatment to patients both virtually and in the company’s Montreal and Vancouver clinics.
Going forward, Numinus plans to expand even further, especially by acquiring more clinics across the country. But they’re guided at every step by principles of patient-centric care, thoughtful expansion, and strategic collaboration.
“Our acquisition strategy is one that is going to be based on thoughtful and intentional gathering of resources,” says Nyquvest. “Clinics we do purchase, or really anyone that we partner with, will be something that's moving our goals forward — we’re not just looking to generate news and interest.”
He adds, “Our lab has been around for many years, participating in extraction of biomass materials. This isn't a lab that’s been brought online to take advantage of a hot psychedelics market.”
Revolutionizing access to healing
In 2021 and beyond, Numinus plans to continue its history of achieving industry firsts. The company plans to launch even more compassionate access trials, and scale up their existing clinical and research activity.
Their psilocybe harvest and cultivation as well as upcoming MDMA trial will extend into the development of treatment protocols for these substances, as well as for ketamine-assisted therapy.
With recent changes in the regulation of psychedelic substances, and milestones such as Numinus’s legal cultivation and harvest, psychedelic therapies are moving closer and closer to becoming accessible to the patients who need them.
If we accept and implement these promising new treatment options, our mental healthcare system is capable of real change — and vastly improved patient outcomes.
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