Finalized study design and protocol mark major
milestone to investigate natural Psilocybin
VANCOUVER, BC, Oct. 20, 2021 /CNW/ - 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 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 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."
About Numinus
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.
Learn more at www.numinuswellness.com and follow us on
LinkedIn, Facebook, Twitter, and Instagram.
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SOURCE Numinus Wellness Inc.