Open-label clinical trial will evaluate and
refine best practices for the delivery of psilocybin-assisted
psychotherapy for participants with tobacco, stimulant, alcohol,
and/or opioid disorders
VANCOUVER, BC, Nov. 18, 2020 /CNW/ - Numinus Wellness Inc.
("Numinus" or the "Company") (TSXV: NUMI), a company creating an
ecosystem of solutions centred on the research, development, and
delivery of safe, evidence-based, accessible psychedelic-assisted
psychotherapies, has announced it will undertake a compassionate
access clinical trial of psilocybin-assisted psychotherapy for
substance use disorders. This study will enable the company to
implement, test, and refine optimal protocols for the use of
psilocybin-assisted psychotherapy for participants with a range of
substance use disorders and will be conducted in collaboration with
Syreon Corporation, a global contract research organization with
expertise in conducting clinical trials across a broad range of
chronic and complex diseases. The study will involve
an initial 30 participants who will take part in a
motivational enhancement psychedelic psychotherapy intervention
with psilocybin.
According to Health Canada's
Special Access Programme, compassionate access single-arm
open-label clinical trials can be incorporated into drug
development planning to "meet the needs of patients who are not
eligible for enrollment in other pivotal trials" and is one of
Health Canada's preferred means for patients to access drugs that
are not yet available on the market.
"Research has already demonstrated great promise for
psilocybin-assisted psychotherapy as a treatment for certain
substance use disorders," said Chief Medical Officer, Dr.
Evan Wood. "But, psilocybin is still
illegal in Canada. This
compassionate access trial will begin to address the hurdle of
public accessibility, while allowing us to evaluate service
delivery models and study the impacts of psilocybin-assisted
psychotherapy as an adjunct to standard of care treatments for
substance use disorders."
The study builds upon a growing body of research demonstrating
psilocybin-assisted psychotherapy's efficacy as a novel treatment
for specific substance use disorders. A pilot study focusing on
tobacco addiction at Johns Hopkins
University found that 12 months after psilocybin
therapy sessions, approximately 70 percent of participants remained
completely abstinent from smoking and approximately 90 percent
rated their psilocybin experience as among the most personally
meaningful experiences of their lives. A study of
psilocybin-assisted psychotherapy for alcohol use disorder at
New York University has also
demonstrated major reductions in alcohol use.
The evolving international regulatory landscape has opened the
door to accessibility of psilocybin-assisted psychotherapy, and
Numinus's compassionate access trial is expected to contribute to
continued interest in expanding access.
"The tides are turning for the regulated use of psilocybin, as
witnessed earlier this month in the
United States. A yes vote for Measure 109 in Oregon permits licensed service providers
to provide psilocybin-assisted psychotherapy, and Health Canada has
an ongoing provision of exemptions for psilocybin for medical use,"
said Founder, CEO, and Chair, Payton
Nyqvest. "By increasing access through a compassionate
access trial, we hope to help lead the way to regulation in
Canada through our implementation
science approach which will provide critical outcome and safety
data to health regulators."
Numinus' compassionate access trial is the first in a series of
planned projects and partnerships aimed at expanding access to MDMA
for treatment of PTSD and psilocybin for treatment of substance use
disorders. These implementation science initiatives will allow the
company to refine clinical protocols and strategies for when these
medications are approved for widespread use by regulating
bodies.
ON BEHALF OF THE BOARD OF NUMINUS WELLNESS INC.
Payton Nyquvest
President, Chief Executive Officer and Chair
About Numinus
Numinus Wellness Inc. (TSXV: NUMI) is a
mental health and wellness company creating an ecosystem of
solutions centred around safe, evidence-based, accessible
psychedelic-assisted psychotherapy to help people heal and be
well.
Numinus Health is dedicated to delivering innovative
treatments to address physical, mental, and emotional health,
through clinics and virtual services.
Numinus R&D is conducting implementation science
and leveraging partnerships to beta-test and refine optimal models
of psychedelic-assisted psychotherapy delivery, setting the stage
for approved routine use in mental health and wellness care.
Numinus Bioscience is focused on developing testing
methods and effective formulas for the evolving psychedelics space.
Health Canada licences, scientific
expertise, and new technologies facilitate ongoing innovation, and
high-throughput contract services generate established revenue.
Learn more at numinus.ca, and follow us on Facebook, Twitter,
and Instagram.
About Syreon
Syreon provides a full suite of
adaptive clinical trials, health economics and outcomes research
ensuring safe, effective and value-driven clinical use of
innovative therapies in more than 40 countries.
Syreon partners with an elite portfolio of global pharmaceutical
corporations and early-stage biotech companies to speed the
evaluation of new therapies and improve health outcomes. Its expert
research services identify precise therapeutic needs, rapidly
evaluate new health interventions, monitor clinical use and define
optimal economic value in today's competitive health
environment.
Syreon scientists have contributed to many groundbreaking
innovations, from the first blockbuster signal inhibitors, chimeric
and humanized monoclonals, recombinant human proteins and companion
diagnostics to the developing fields of immuno-oncology, stem cell
therapeutics and other recent initiatives in precision
medicine.
Syreon's head offices in North
America and Europe
coordinate an international network of regional offices and expert
research teams providing personal support and professional
coordination to clients, investigators, providers, purchasers and
payers. Our services through all phases of study planning,
operation, analysis and reporting ensure safe, effective and
value-driven clinical use.
www.syreon.com
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SOURCE Numinus Wellness Inc.