As jurisdictions such as Canada demonstrate increasing interest in providing access to psychedelic-assisted therapies, many organizations are seeking to address ways to safely and effectively meet future demand for such treatments. Here, we take a look at how Numinus is aiming to apply an implementation science approach to guide the development of the sector in a responsible way.
The company is active across a number of areas, from cultivation through to compassionate access trials. In June 2020, the company received Health Canada approval to carry out research on standardizing the extraction of psilocybin from mushrooms. This success was quickly followed by the announcement of a partnership with MAPS, the acquisition of Mindspace Wellbeing, and a compassionate access trial with Syreon. At present, Psilocybin Alpha understands that Numinus is among the most extensively licensed public companies in the North American psychedelics space.
With three distinct but complementary business foci—Numinus Health, Numinus R&D, and Numinus Bioscience—Numinus positions itself as a leader in both the development and delivery of safe, evidence-based psychedelic-assisted psychotherapies. It is around these two pivotal features of the psychedelics business model that Numinus’ plans and operations coalesce.
Development
Numinus’ focus on development within the psychedelics sphere is expressed through a number of key strategies: research and development activity via their licenced laboratory; informing policy, reform, and regulations; identifying formulations and methods for a safe supply; and, collaborating with research partners to advance clinical study.
The Numinus R&D and Bioscience arms are particularly focused on achieving these development-oriented objectives. Numinus R&D develops clinical and therapeutic protocols for use in treatments and in collaboration with research partners and government regulators, while Numinus Bioscience occupies the development domain of formulations and methods that guarantee safe supply of psychedelic medicine and cutting-edge technology.
In a broader manner on the development front, Numinus is also helping to usher in regulatory changes at a governmental level. The company’s clinical advisory board submitted a briefing document to the Canadian Minister of Health with recommendations for the revision of Canada’s Special Access Program, which would allow psychedelic-assisted therapies to be considered once again. Through a discursive and advisory relationship with regulators, Numinus is contributing to the advancement of psychedelic-assisted therapy protocols and technologies at a broader level.
“There are clear signals from regulators and the market to support this industry,” says Dr. Evan Wood, Chief Medical Officer at Numinus. Wood notes that little opposition exists politically to the idea of using psychedelics to help with mental health challenges. “I don’t think we’re seeing the same kind of political headwinds that we’re seeing, for instance, with medical cannabis. I just don’t see that–I think there’s reason for optimism.”
As the pace of regulatory change accelerates, Numinus is one of the growing number of companies seeking to stay agile, with a mind to entering new regulatory spaces that may emerge. For example, the company has launched a program focused on the cultivation of psilocybe mushrooms at its Health Canada licensed facility, purpose-designed for undertaking applied research, IP development, and growing plant-based psilocybin for therapeutic use in its clinics.
However, this move also allows the company to explore supply agreements and R&D partnerships with research organizations and companies without their own facilities. This revenue stream is evidenced through the company’s recent lab services agreement with Optimi Health (CSE: OPTI). Optimi will leverage the services, laboratories, expertise and specialized equipment of Numinus as they oversee their goal of developing psilocybin-based products for the psychedelics industry. This is a particularly interesting development, which could prove to provide a shorter-term revenue stream, in addition to organic collaboration with other organisations in the space.
Delivery
Within Numinus’ company structure, Numinus Health is broadly responsible for the delivery of psychedelic-assisted therapy, virtual services, promoting special access pathways to psilocybin and MDMA, and supporting compassionate access trials. The recent acquisition of Mindspace has further extended the company’s ability to deliver transformative psychedelic treatments, particularly its ketamine-assisted therapy program.
Numinus’ recent collaboration agreement with MAPS Public Benefit Corporation will also see important research undertaken in the form of a single-arm, open-label, compassionate access trial on psychedelic-assisted therapy for PTSD. The collaboration on this trial leverages Numinus’ clinical infrastructure, which is combined with MAPS’ evidence-based treatment protocol.
The compassionate access trial will be conducted at Numinus’ Vancouver Clinic, and is now in the pre-implementation stage. A rigorously trained cohort of Numinus therapists, who recently graduated from the MAPS’ MDMA therapist training program, will oversee the trial and collect safety data for eventual submission Health Canada. The trial is the first of its kind in Canada, and represents a step towards legal MDMA-assisted psychotherapy in the country. By building a case for regulatory approval, there is the potential for improved, more effective treatments for individuals suffering with PTSD.
Numinus has also teamed up with Syreon to deliver another compassionate access trial which will soon get underway. The trial, which is investigating psilocybin-assisted motivation enhanced therapy as a treatment for patients with substance use disorders, is currently in the development stage with the treatment protocol recently finalized. The protocol has been subjected to two rounds of external expert review by a leading psychedelic research foundation, and is designed to produce rapid motivation to change in participants. This treatment has the potential to dramatically transform the lives of the thirty individuals who participate in the study, and those in future who may benefit from treatment.
The Road Ahead
Numinus’ involvement in these clinical trials is perhaps representative of the company’s commitment to implementation science by facilitating the safe and effective delivery of psychedelic-assisted therapy from clinical settings into the community. This commitment to facilitating psychedelic treatments and trials is apparently driven by a belief among the company’s leaders in the power of psychedelics to enact positive and enduring transformation, in comparison with current mental health medications.
“70 percent of people described their psychedelic-assisted psychotherapy as one of the top five spiritual experiences they’ve ever had in their lives,” reflects Wood. “There’s no home-run benefit to conventional drugs, and if you look at real-world experience with patients, most patients don’t like taking them. People don’t like how it feels to be on these drugs, which you have to take everyday.”
“On the one hand, you have this medicine that doesn’t look like it works very well, and has side effects people don’t like. And on the other, you have this treatment that looks incredibly promising; it looks safe, and people appreciate the experience.”
As the pace of regulatory change accelerates and psychedelic-assisted therapies become more accessible, a focus on the development of safe and efficacious therapeutic protocols for use in ‘real-world’ scenarios is of increasing interest to many in the space. Numinus’ focus on both lab-based R&D and a contribution to the safe and successful delivery of psychedelic medicine via protocol development suggest the team are cognizant of this trend.
One thing’s for certain: as it stands, the future of this nascent field—and those who stand to benefit from treatment—looks bright.
Company Profile
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