Psychedelics firm Numinus Wellness Inc. is advancing its first proprietary psilocybin-based formulation to the clinical trial process.
In a statement Friday, the company said it submitted a clinical trial application to Health Canada for its Phase 1 study, dubbed Hope, on a “naturally derived psilocybe extract formulation,” NBIO-01.
The proprietary formulation is the first to be developed with extracts generated using Numinus’s patent-pending technology, for which a patent was submitted to the US Patent and Trade Office last year.
The company says the formulation has been developed to stably deliver psilocybin with other synergistic compounds, and will be studied for safety and bioavailability.
If approved, it will mark Numinus’s first independent clinical trial, which will be a two-phase study at its clinic in Vancouver. The firm says it will begin testing the extract in 20 healthy volunteers, followed by testing against a psilocybin comparator in another 28 healthy volunteers.
“This application significantly advances our product development pipeline, which is aimed at broadening access to safe and effective products for psychedelic-assisted therapies,” says Sharan Sidhu, science officer and general manager of Numinus’s Bioscience division.
“The trial will assess safety and bioavailability and be a stepping stone to the next stage for our IP development,” she says.” This natural product has been developed to be shelf stable, minimally variable and consistently meet label claims.”
The firm began a Phase 1 clinical trial last year to test the safety of natural psilocybin last year.
On Jan. 1, Canada’s Special Access Program was amended, allowing patients with severe health conditions to access psilocybin and other restricted substances. Numinus, which has special licensing to legally produce psilocybin, is listed as a supplier for the program.
Company stock was flat on Friday at $0.70 on the Toronto Stock Exchange.