Numinus Wellness Inc (CVE:NUMI) (OTCMKTS:LKYSF) (FRA:LR23) announced that it has formed a partnership with KGK Science, a leading contract research organization with expertise in natural products, to undertake a new psilocybin extraction clinical trial.
Numinus said the Phase 1 trial will enroll 14 human volunteers and assess the safety and psychoactive properties of a psilocybe mushroom product extracted and formulated at the Numinus Bioscience lab in British Columbia.
The company noted that successful completion of the landmark trial would result in safety and efficacy data for a natural psilocybin product, which could subsequently be used for further research and government-approved special access or compassionate access programs.
READ: Numinus Wellness plans expansion of psychedelics research laboratory
In addition, the trial would support Canada's leadership in the safe production of a key psychedelic that has shown promise in treating mental health conditions, including depression, end of life anxiety, and substance use disorders, when used in conjunction with a standardized psychotherapy program under clinical supervision.
"This Phase 1 trial supports our mandate to improve access to safe, evidence-based psychedelic-assisted therapies in Canada and around the world," said Numinus CEO Payton Nyquvest in a statement.
"Through this trial, we expect to demonstrate that Numinus is well ahead in the development of natural Psilocybin therapeutics that are safe for humans and can be used to support our sector's growth through sales to other research organizations, the creation of new intellectual property, and the ability to conduct our own Phase 2 and Phase 3 clinical trials, if we choose to do so."
Numinus is less than three years old, but already has a history of innovation in psychedelics. Numinus completed the first legal extraction of psilocybe mushrooms in Canada by a public company for research and development purposes and completed the cultivation and harvest of the first legal flush of psilocybe mushrooms.
"We believe there are several likely advantages to naturally occurring Psilocybin therapeutics that will make them attractive for researchers and consumers alike," said Sharan Sidhu, science officer and general manager at Numinus Bioscience.
"We are confident that this trial will document that natural Psilocybin extractions meet health regulator requirements for safety, efficacy and quality, and ultimately enable the establishment of better access to this medicine."
Currently, Numinus is also partnering with Syreon Corporation, a global contract research organization, to undertake a single-arm, open-label compassionate access trial that will assess the efficacy and safety of psilocybin-assisted motivational enhancement therapy using a synthetic psilocybin product.
The study will contribute to a growing body of research to inform larger randomized controlled trials for these indications. The study will take place in Vancouver and will enroll 30 individuals with opioid, stimulant, and/or alcohol use disorders.
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