The application is for a clinical trial that intends to test the psilocybin extract for bioavailability and tolerability on 20 healthy volunteers.
Numinus Wellness has submitted an application to Health Canada for its Phase I study, HOPE, on its naturally derived psilocybe extract formulation, NBIO-01.
HOPE is a two-phase study that will take place at a Numinus’ clinic in Vancouver. The company intends to begin testing the extract for bioavailability and tolerability on 20 healthy volunteers, followed by testing against a psilocybin comparator on a further 28 healthy volunteers, if approved.
Science officer and general manager at its Health Canada-licensed research facility, Numinus Bioscience, Sharan Sidhu, commented: “This application significantly advances our product development pipeline, which is aimed at broadening access to safe and effective products for psychedelic-assisted therapies.
“The trial will assess safety and bioavailability and be a stepping stone to the next stage for our IP development.
“This natural product has been developed to be shelf stable, minimally variable and consistently meet label claims. The trial will not only assess safety but also give us data on comparative bioavailability.”
“At Numinus, we are focused on developing products and services in-house to ensure that high-quality standards are maintained,” added Payton Nyquvest, founder and CEO.
”I am very proud of the Numinus team – from our Bioscience experts who developed the product, to our clinical research team who will administer the study.
“We look forward to achieving more milestones in our mission to make psychedelic-assisted therapies accessible to all who wish to safely use them.”
NBIO-01 is Numinus Bioscience’s first proprietary formulation developed from extracts generated using patent-pending technology.
A patent was earlier submitted to the US Patent and Trade Office and announced on June 24, 2021. The formulation has been developed to stably deliver psilocybin and other synergistic compounds.
