Clinical trial will evaluate safety and
psychoactive properties of natural Psilocybin product
extracted and formulated at 7,000-square-foot laboratory in
British Columbia, Canada
VANCOUVER, BC, April 26, 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, announced today that
it has formed a partnership with KGK Science, a leading contract
research organization with expertise in natural products, to
undertake a new Psilocybin extraction clinical trial.
The Phase 1 trial will enroll 14 human volunteers and assess the
safety and psychoactive properties of a Psilocybe mushroom
product extracted and formulated at the Numinus Bioscience lab in
British Columbia, Canada.
Successful completion of the landmark trial would result in safety
and efficacy data for a natural Psilocybin product which could
subsequently be used for further research and
government-approved special access or compassionate access
programs.
In addition, the trial would support Canada's leadership in the safe production of
a key psychedelic that has shown promise in treating mental health
conditions including depression, end of life anxiety and substance
use disorders, when used in conjunction with a standardized
psychotherapy program under clinical supervision.
"This Phase 1 trial supports our mandate to improve access to
safe, evidence-based psychedelic-assisted therapies in Canada and around the world," said
Payton Nyquvest, CEO, Numinus.
"Through this trial, we expect to demonstrate that Numinus is
well ahead in the development of natural Psilocybin therapeutics
that are safe for humans and can be used to support our sector's
growth through sales to other research organizations, the creation
of new intellectual property, and the ability to conduct our own
Phase 2 and Phase 3 clinical trials, if we choose to do so."
"We're thrilled to help lead ground-breaking clinical work using
Psilocybin," said Najla Guthrie,
President & CEO, KGK Science. "Our team's expertise in the area
of natural health products makes us uniquely positioned to
contribute to the burgeoning psychedelics industry."
Numinus is less than three years old, but already has a history
of innovation in psychedelics. Numinus completed the first legal
extraction of Psilocybe mushrooms in Canada by a public company for research and
development purposes, and completed the cultivation and harvest of
the first legal flush of Psilocybe mushrooms.
"We believe there are several likely advantages to naturally
occurring Psilocybin therapeutics that will make them
attractive for researchers and consumers alike," said Sharan Sidhu, Science Officer and General
Manager at Numinus Bioscience. "We are confident that this trial
will document that natural Psilocybin extractions meet health
regulator requirements for safety, efficacy and quality, and
ultimately enable the establishment of better access to this
medicine."
"We are excited to see Health Canada grant legal exemptions for
certain patients to use Psilocybin alongside psychotherapy in
situations when other treatments have failed, and to consider
revisions to its Special Access Programme that could allow Canadian
patients access to psychedelic medications when other drugs have
been unsuccessful," added Dr. Evan
Wood, Chief Medical Officer, Numinus. "As research interest
and the potential for increased compassionate access to Psilocybin
grows, it is imperative that patients have access to safe,
pharmaceutical-grade supply that offers consistent psychoactive
properties at scale. With this trial, we are taking the first steps
towards that goal."
Currently, Numinus is also partnering with Syreon Corporation, a
global contract research organization, to undertake a single-arm,
open-label compassionate access trial that will assess the efficacy
and safety of Psilocybin-assisted motivational enhancement therapy
using a synthetic Psilocybin product. The study will contribute to
a growing body of research to inform larger randomized controlled
trials for these indications. The study will take place in
Vancouver and will enroll 30
individuals with opioid, stimulant and/or alcohol use
disorders.
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 KGK
As a global Contract Research Organization
(CRO), KGK Science performs a productive and pioneering role in the
realm of scientific study. For over two decades, it has offered
well-designed, customized solutions to each of its clients,
consolidating its scientific, clinical, commercial, and regulatory
abilities into one full-service package. Equipped with
state-of-the-art technologies, novel research techniques, and a
seasoned team of thought leaders, KGK remains at the forefront of
its industry. And, by seamlessly matching its experience with its
drive for innovation, this CRO is able to respond effectively to
expanding trade and consumer demands.
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regulatory or political change such as changes in applicable laws
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competition, including from more established or better financed
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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
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SOURCE Numinus Wellness Inc.