Numinus Wellness Inc. (TSX-V:NUMI, OTC:LKYSF) revealed that it has finalized the study design and protocol for a Phase 1 clinical trial on a naturally derived psilocybin extract.
The Vancouver, British Columbia-based mental healthcare company advancing psychedelic-assisted therapies, said the major milestone advances Numinus' investigation of its first proprietary psychedelic product, which was developed using a patent-pending technology submitted to the US Patent and Trade Office (USPTO).
The company said that its bioscince lab, Numinus Bioscience has successfully developed a natural extract, PSYBINA from Psilocybe species using IP technology related to the production of extracts and downstream derivatives and formulations from psychoactive species cultured mycelium.
Numinus Bioscience is the company's Health Canada-licensed lab for psychedelic substance research, developing IP while offering analytics services for revenue generation.
The Phase I clinical trial, titled "A Healthy Adult Investigation Observing Endpoint Measures of Safety and Relative Bioavailability of Psilocybin in comparison to a Psilocybe extract” (HOPE), will be a fasting, blinded, crossover study.
It will ascertain the safety and bioavailability of a formulation of PSYBINA RX developed to stably deliver psilocybin and other synergistic compounds. “The trial design compares the innovative formulation, designed to be more bioavailable, with synthetic psilocybin as a baseline comparator and exploratory brain scans will visualize the potential differences in neuroactivity,” said the company.
With its licensed capabilities, Numinus' lab will produce, package and label both PSYBINA RX and the psilocybin comparator for the clinical trial which will be conducted at Numinus' clinical site in Vancouver on 14 healthy volunteers.
"This is a benchmark trial for Numinus Bioscience as it not only tests our theory of synergies of natural complex matrices but also our product design and patent-pending technology," Sharan Sidhu, who is the Science Officer and General Manager at Numinus Bioscience, said in a statement.
"Our research team has developed PSYBINA RX to be stable and more bioavailable, which, coupled with 75% more efficient production of PSYBINA using our technological advancements, aims to reduce our production costs of therapeutic products, further advancing our mission of increasing accessibility in psychedelic medicine."
Numinus Wellness CEO Payton Nyquvest noted that the Phase 1 launch leverages “multiple Numinus assets,” including the firm’s clinical research team and Numinus Bioscience team who are working together to successfully develop and run the clinical trial.
"The majority of the work from discovery, research and development, production, clinical trial application and trial conduct are all happening in house, demonstrating our leadership and capabilities in psychedelic therapeutics," Nyquvest added.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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