Partnership Aimed at Delivering
Psychedelic
Capsule for Dosing Study in Human Clinical
Trial
VANCOUVER, BC, May 11, 2021 /CNW/ - Numinus Wellness Inc.
("Numinus" or the "Company") (TSXV: NUMI), a mental health care
company advancing innovative treatments and safe, evidence-based
psychedelic-assisted therapies, and Optimi Health Corp.
(CSE: OPTI) (OTC: OPTHF) (FRA: 8BN), developers of a vertically
integrated functional mushroom brand focused on the health and
wellness sector, have met another early milestone in the
development of an initial all natural psilocybin extract.
Optimi and Numinus, through Impact Clinical Trials Accelerator
at the University of Calgary
("Impact"), have submitted a pre-clinical trial application to
Health Canada for review and comment. Meanwhile, cultivation,
research, formulation and continuous validation studies to produce
the investigational psilocybin extract for trial continue at the
Health Canada-licensed Numinus lab in British Columbia, Canada.
Key information submitted in the information package provided to
Health Canada includes the investigational product's chemical
constituents, genotype, and formulation as well as procedures and
processes to produce a consistent dosage from Psilocybe
mushrooms.
With Health Canada's feedback and anticipated regulatory
approvals, Numinus plans to use the candidate mushroom clone to
develop a uniform all-natural psilocybin capsule for use in
Optimi's human clinical trials, initially for a dosing study and
then expanding into trials for a variety of human health
conditions.
Optimi will retain 100% ownership of the resulting all-natural
psilocybin capsule and full intellectual property rights to its
use.
Optimi Chairman of the Board JJ Wilson comments, "This is
another important step for our commitment to the development of
naturally sourced, evidence-based product formulations. As a
cornerstone of our brand positioning, we believe that future
consumer demand will be based on efficacy, cost, and source
integrity. By using natural products, we seek to unlock the full
value potential in this sector. With the work we are embarking on
today with the teams at Numinus and Impact, we are aiming for what
we hope will become blockbuster candidates able to significantly
transform the mental health therapeutic landscape, while remaining
true to historic principles and natural organic origins."
"Numinus is pleased to partner with Optimi on this important
work and provide the expertise, licensed facility and specialized
equipment required to quickly develop, formulate and rigorously
test products derived from natural Psilocybe sources and prepare
them for Health Canada submissions and approvals," said
Sharan Sidhu, Science Officer and
General Manager, Numinus Bioscience. "We look forward to continuing
our work with Optimi to develop safe, standardized and reproducible
products that provide meaningful and accurate clinical trial
data."
Numinus Bioscience recently received amendments to its federal
license to allow the possession, production, assembly, sale,
export, and delivery for a wide variety of psychedelics including –
for the first time – Ketamine and Lysergic acid diethylamide (LSD).
The amendment also supports Numinus Bioscience's role in activities
related to Mescaline, N, N-Dimethyltryptamine (DMT), N-Methyl 3,4,
methylenedioxyamphetamine (MDMA), Psilocin and Psilocybin.
About Numinus
Numinus Wellness (TSX-V: NUMI) empowers
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 Wellness 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 abuse. 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 numinus.ca, and follow us on Facebook, Twitter,
and Instagram.
About Optimi (CSE: OPTI) (OTC: OPTHF) (FRA: 8BN)
Optimi is developing a sophisticated mushroom brand that focuses on
the health and wellness markets. With a vertically integrated
approach, Optimi intends to cultivate, extract, process and
distribute high quality functional mushroom products at its two
facilities comprising a total of 20,000 square feet nearing
completion in Princeton, British
Columbia. To fully investigate the science of mushrooms, the
Company has received a research exemption under Health Canada Food
and Drug Regulations (FDR) for the use of Psilocybin and Psilocin
for scientific purposes via its wholly owned subsidiary Optimi Labs
Inc. Optimi has also applied for a dealer's license under
Canada's Narcotic Control
Regulations governing possession, distribution, sale, laboratory
analysis of and research and development of Psilocybin and Psilocin
formulations. Optimi is committed to expert cultivation and quality
production subject to and in accordance with the terms of all
applicable laws and governing regulations to ensure safe, superior
Canadian fungi production.
Find out more at: https://optimihealth.ca/.
Forward-Looking Statements
This news release
contains forward-looking statements within the meaning of
applicable securities laws. All statements that are not historical
facts, including without limitation, statements regarding future
estimates, plans, programs, forecasts, projections, objectives,
assumptions, expectations or beliefs of future performance, are
"forward-looking statements". Forward-looking statements can be
identified by the use of words such as "plans", "expects" or "does
not expect", "is expected", "estimates", "intends", "anticipates"
or "does not anticipate", or "believes", or variations of such
words and phrases or statements that certain actions, events or
results "may", "could", "would", "might" or "will" be taken, occur
or be achieved. Such forward-looking statements involve known and
unknown risks, uncertainties and other factors that may cause
actual results, events or developments to be materially different
from any future results, events or developments expressed or
implied by such forward-looking statements. Such risks and
uncertainties include, among others, dependence on obtaining and
maintaining regulatory approvals, including acquiring and renewing
federal, provincial, municipal, local or other licences and any
inability to obtain all necessary governmental approvals, licences
and permits to operate and expand the Company's facilities;
regulatory or political change such as changes in applicable laws
and regulations, including federal and provincial legalization of
psychedelic therapies, due to inconsistent public opinion,
perception of the medical-use of psychedelics, delays or
inefficiencies or any other reasons; any other factors or
developments which may hinder market growth; the Company's limited
operating history and lack of historical profits; reliance on
management; the Company's requirements for additional financing,
and the effect of capital market conditions and other factors on
capital availability; competition, including from more established
or better financed competitors; the need to secure and maintain
corporate alliances and partnerships, including with research and
development institutions, customers and suppliers; the development
and implementation of medical protocols and treatment standard
operating procedures for the use of psychedelic therapies; the
Company's goals to develop and implement partnerships with research
organizations and other key players in the integrative mental
health industry; the Company's ability to successfully withstand
the economic impact of COVID-19; the medical benefits, safety,
efficacy, dosing and social acceptance of psychedelics; the
approval and/or success of compassionate access clinical trials;
the cultivation and harvest of Psilocybe mushrooms; and the
availability of trained personnel and medical professionals. These
factors should be considered carefully, and readers are cautioned
not to place undue reliance on such forward-looking statements.
Although the Company has attempted to identify important risk
factors that could cause actual actions, events or results to
differ materially from those described in forward-looking
statements, there may be other risk factors that cause actions,
events or results to 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 has no obligation to update any
forward-looking statement, even if new information becomes
available as a result of future events, new information or for any
other reason except as required by law.
Neither the TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
SOURCE Numinus Wellness Inc.