Finalized study design and protocol mark major milestone to investigate natural Psilocybin
Numinus Wellness Inc. ("Numinus" or the "Company") (TSXV: NUMI), a leader in psychedelics-focused mental healthcare, is pleased to have finalized the study design and protocol for a Phase 1 clinical trial on a naturally derived Psilocybin extract, previously announced on April 26, 2021 . This 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.
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 RX TM 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 Vancouver, British Columbia 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," says Sharan Sidhu , Science Officer and General Manager at Numinus Bioscience. "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."
"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 Payton Nyquvest , Founder & CEO, Numinus. "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."
Numinus Wellness (TSXV: NUMI) helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model - including psychedelic production, research and clinic care - is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.
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SOURCE Numinus Wellness Inc.