Mental health and wellness company focusing on administering psychedelic medicine with holistic integrated psychotherapy Numinus Wellness Inc. (TSX: NUMI) has submitted clinical trial application (CTA) to Health Canada for the Phase 1 on naturally extracted psilocybe extract formulation NBIO-01.
This clinical study has been dubbed ‘HOPE’ and the company says this will be a milestone and a progress which will strengthen its long-standing work on developing safe and effective psychedelic products from Numinus Bioscience, its researched facility licensed by Health Canada.
NBIO-01 is the company’s first proprietary formulation developed from extracts generated from using patent-pending technology this formulation has been developed to stably deliver psilocybin and other synergistic compounds. Numinus submitted a patent application to the United States Patent and Trademark Office (USPTO) back on June 24, last year.
“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,” said the company’s chief science officer, Sharan Sidhu.