Numinus Wellness Inc. (TSXV: NUMI), a leader in psychedelics-focused mental healthcare, recently announced that the study design and protocol for a Phase 1 clinical trial on a naturally derived Psilocybin extract, which was originally announced on April 26, 2021, has been finalized. Numinus’ investigation of its first proprietary psychedelic substance, which was developed utilizing a patent-pending technology submitted to the US Patent and Trade Office, has reached a key milestone.
Using IP technologies relating to the synthesis of extracts, downstream derivatives, and formulations from Psychoactive Species Cultured Mycelium, Numinus Bioscience has successfully created a natural extract, PSYBINA, from Psilocybe species.
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: a fasting, blinded, crossover study” (HOPE), will assess the safety and bioavailability of the subsequent formulation PSYBINA RX, which is designed to deliver Psilocybin and other synergistic compounds in a stable manner. The experiment will compare the novel formulation, which is supposed to be more bioavailable, to synthetic Psilocybin as a baseline comparator, using exploratory brain scans to visualize any variations in neuroactivity.
Numinus’ lab will create, package, and label both PSYBINA RX and the Psilocybin comparator for the clinical trial, which will be conducted on 14 healthy volunteers at Numinus’ clinical location in Vancouver, British Columbia, using its approved capabilities.
