After completing the first legal extraction of psilocybe mushrooms in Canada last year, Numinus Wellness Inc. (TSX-V: NUMI) is launching a new study to test the safety and efficacy of the psychedelic compound on humans.
On Monday, the British Columbia-based firm said its Phase 1 trial will enroll 14 volunteers to gather data on the natural psilocybin product to support further research and government-approved special access programs.
Emerging science shows that psilocybin can be used to treat mental health conditions including depression, end-of-life anxiety and substance use issues when taken under clinical supervision alongside psychological support. However, most major research has so far used synthetic psilocybin.
Numinus science officer Sharan Sidhu says the company expects the trial will show several advantages to naturally occurring psilocybin over synthetic forms, which will be attractive for researchers and consumers.
Numinus has teamed up with KGK Science, a London, Ontario-based contract research company, to support the trial. Their end goal is to improve access to evidence-based, psychedelic-assisted therapies with natural psilocybin in Canada and around the world.
“Although there is subjective data for human safety and efficacy, there is a lack of statistically significant data on natural psilocybe extracts,” Numinus CEO Payton Nyquvest told Mugglehead in an email.
“Generating more data will help to inform regulators about the safety of products derived from psilocybe mushrooms, thereby increasing their confidence in revising policy to make psilocybin-assisted therapies more accessible.”
Numinus joins Canada’s push for legal psilocybin treatments
Since 2020, Canada has been a global leader in granting patient access to psychedelic therapy with controlled substances.
Through a series of legal exemptions, Health Minister Patty Hajdu granted 14 terminally ill patients legal use of psilocybin as treatment for end-of-life distress.
The minister also approved 17 healthcare professionals to possess and use the fungus-derived compound for professional training in psilocybin therapy.
“We are excited to see Health Canada grant legal exemptions for certain patients to use psilocybin alongside psychotherapy,” Numinus chief medical officer Dr. Evan Wood said in a statement. “It is imperative that patients have access to safe, pharmaceutical-grade supply that offers consistent psychoactive properties at scale. With this trial, we are taking the first steps towards that goal.”
If the study proves the natural psychedelics are safe, CEO Nyquvest says it will help Numinus grow the sector through sales to other research organizations, the creation of new intellectual property as well as the ability to conduct future Phase 2 and Phase 3 clinical trials.
Criteria for safety of the Phase 1 trial include gathering blood samples from volunteers to confirm metabolic toxicity, as well as data on their electrolyte levels, the health of their liver and kidneys, and any adverse reactions.
Psilocybin will be administered orally in capsule form. The trial will take place at Numinus Bioscience lab in Nanaimo, B.C.
Nyquvest points to numerous studies around the benefits of psychedelic mushrooms, including a 2016 study by researchers at Johns Hopkins University that found psilocybin relieved anxiety and depression in people with a life-threatening cancer diagnosis.
A second small, but robust study of 27 adults conducted at Johns Hopkins University last year found that psilocybin scored higher as an effective treatment for severe depression than traditional antidepressent medications.
And this month, researchers at the Imperial College of London published a study that showed two doses of psilocybin treated depression at least on par and faster than the leading antidepressant sold under brand names such as Cipralex and Lexapro.
However, synthetic psilocybin was used in all three of those landmark trials.
While Numinus looks to expand natural psilocybin research, it’s also studying the psychedelic in synthetic form.
The company has also partnered with Syreon Corp., a global drug research organization, to undertake a single-arm trial that will assess the efficacy and safety of psilocybin-assisted motivational therapy using a synthetic product.
The firm says the study will contribute to the growing body of research and larger randomized controlled trials in future. The reserach will take place in Vancouver and will enroll 30 individuals with opioid, stimulant and alcohol-use conditions.
Numinus has also received amendments to its federal licence under Canada’s Controlled Drugs and Substances Act to expand its Nanaimo research facility to support further trials.
Top image via Numinus