Numinus Wellness has announced the submission of the clinical trial application (CTA) to Health Canada to commence the Phase I clinical trial of a naturally derived Psilocybe extract formulation, NBIO-01, for psychedelic-assisted therapies.
The latest development established the company’s work on developing safe psychedelic therapies at its research facility, Numinus Bioscience, licensed by Health Canada.
The facility’s proprietary formulation NBIO-01 is made from extracts obtained using patent-pending technology.
This formulation was created to offer psilocybin, as well as other synergistic compounds, in a stable manner and will be assessed for its safety and bioavailability.
Named HOPE, the completely autonomous, two-phased trial will be carried out at a Numinus clinic in Vancouver, Canada.
On obtaining approval, the company will assess the bioavailability and tolerability of the product on 20 subjects who are healthy. This will subsequently be followed by an assessment against a psilocybin comparator on additional 28 healthy subjects.
Numinus Bioscience science officer and general manager Sharan Sidhu said: “This application significantly advances our product development pipeline, which is aimed at broadening access to safe and effective products for psychedelic-assisted therapies.
“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.”
Last October, the company finalised the trial design and protocol for a Phase I study of a naturally obtained Psilocybin extract.
Leveraging IP technology linked to the production of extracts and downstream derivatives and formulations from Psychoactive Species Cultured Mycelium, PSYBINA, a natural extract was developed from Psilocybe species.
According to the study design, the new formulation will be compared to synthetic Psilocybin as a baseline comparator with exploratory brain scans expected to show the possible changes in neuroactivity.