Finalized study design and protocol mark major milestone to investigate natural Psilocybin
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. The Phase I clinical trial, "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 ascertain the safety and bioavailability of the subsequent formulation PSYBINA RXTM 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.
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
"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," says
"The Phase 1 launch leverages multiple Numinus assets, including our Clinical Research team and Numinus Bioscience team working together to successfully develop and run this clinical trial," says
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