The trial evaluates Numinus' first trademarked
product and patent-pending production process
VANCOUVER, BC, Jan. 14, 2022 /CNW/ - Numinus Wellness
Inc. ("Numinus") (TSX: NUMI), a leader in
psychedelics-focused mental healthcare, is pleased to announce that
it has formally submitted the clinical trial application ("CTA") to
Health Canada for its Phase 1 study, HOPE, on a naturally derived
Psilocybe extract formulation, NBIO-01. This milestone
further progresses and solidifies Numinus' long-standing work on
developing safe and effective psychedelic products out of its
Health Canada-licensed research facility, Numinus Bioscience.
"This application significantly advances our product development
pipeline, which is aimed at broadening access to safe and effective
products for psychedelic-assisted therapies," says Sharan Sidhu, Science Officer and General
Manager, Numinus Bioscience. "The trial will assess safety and
bioavailability and be a stepping stone to the next stage for our
IP development. This natural product has been developed to be shelf
stable, minimally variable and consistently meet label claims. The
trial will not only assess safety but also give us data on
comparative bioavailability."
NBIO-01 is Numinus Bioscience's first proprietary formulation
developed from extracts generated using patent-pending technology,
for which a patent was earlier submitted to the US Patent and Trade
Office and announced on June 24,
2021. The formulation has been developed to stably
deliver psilocybin and other synergistic compounds and will be
studied for safety and bioavailability.
As Numinus' first fully autonomous clinical trial, HOPE is a
two-phase study that will take place at a Numinus clinic in
Vancouver. Upon approval, Numinus
will begin testing the extract for bioavailability and tolerability
on 20 healthy volunteers, followed by testing against a psilocybin
comparator on a further 28 healthy volunteers.
"At Numinus, we are focused on developing products and services
in-house to ensure that high-quality standards are maintained,"
says Payton Nyquvest, Founder &
CEO, Numinus. "I am very proud of the Numinus team – from our
Bioscience experts who developed the product, to our clinical
research team who will administer the study. We look forward to
achieving more milestones in our mission to make
psychedelic-assisted therapies accessible to all who wish to safely
use them."
About Numinus
Numinus Wellness (TSX: NUMI) helps
people to heal and be well through the development and delivery of
innovative mental healthcare 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.numinus.com and follow us on LinkedIn,
Facebook, Twitter, and Instagram.
Forward-looking statements
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contains forward-looking statements within the meaning of
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regarding future estimates, plans, programs, forecasts,
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that certain actions, events or results "may", "could", "would",
"might" or "will be" taken, will occur or will be
realized. Such forward-looking statements involve risks,
uncertainties and other known and unknown factors that could cause
actual results, events or developments to differ materially from
the results, events or developments expected and expressed or
implied in such forward-looking statements. These risks and
uncertainties include, but are not limited to, dependence on
obtaining and maintaining regulatory approvals, including the
acquisition and renewal of federal, provincial, municipal, local or
other licenses, and any inability to obtain all necessary
government authorizations, licenses and permits to operate and
expand the Company's facilities; regulatory or policy changes
such as changes in applicable laws and regulations, including
federal and provincial legalization, due to fluctuations in public
opinion, industry perception of integrative mental health,
including the use of psychedelic-assisted therapy, delays or
inefficiencies or any other reason; any other factor or
development likely to hamper the growth of the market; the
Company's limited operating and profitability track
record; dependence on management; the Company's need for
additional financing and the effects of financial market conditions
and other factors on the availability of
capital; competition, including that of more established
and better funded competitors; the continued impact of the
COVID-19 pandemic; and the need to build and maintain alliances and
partnerships, including with research and development companies,
customers and suppliers. These factors should be carefully
considered, and readers are cautioned not to place undue reliance
on forward-looking statements. Despite the Company's efforts
to identify the main risk factors that could cause actual measures,
events or results to differ materially from those described in
forward-looking statements, other risk factors may cause measures,
events or developments to materially differ from those anticipated,
estimated or intended. There can be no assurance that
forward-looking statements will prove to be accurate, as
actual results and future events could differ materially from those
anticipated in forward-looking statements. The Company does
not undertake to revise forward-looking statements, even if new
information becomes available as a result of future events, new
facts or any other reason, except as required by applicable
laws.
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SOURCE Numinus Wellness Inc.