Clinical trial will evaluate safety and psychoactive properties of natural Psilocybin product
extracted and formulated at 7,000-square-foot laboratory in British Columbia, Canada
VANCOUVER, BC, April 26, 2021 /CNW/ – Numinus Wellness Inc. (“Numinus” or the “Company”) (TSXV: NUMI), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, announced today 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.
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, Canada. 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.
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 Payton Nyquvest, CEO, Numinus. “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.”
“We’re thrilled to help lead ground-breaking clinical work using Psilocybin,” said Najla Guthrie, President & CEO, KGK Science. “Our team’s expertise in the area of natural health products makes us uniquely positioned to contribute to the burgeoning psychedelics industry.”
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…