Significant progress made as Numinus-sponsored
PRIME study on psilocybin-assisted psychotherapy for opioid,
stimulant and/or alcohol use disorders enters pre-implementation
stage
VANCOUVER, BC, March 2, 2021 /CNW/ - Numinus Wellness Inc.
("Numinus" or the "Company") (TSXV: NUMI), a company creating an
ecosystem of health solutions centered around developing and
supporting the safe, evidence-based, accessible use of
psychedelic-assisted psychotherapies (PAP), and Syreon
Corporation (Syreon), a global contract research organization
with expertise in conducting clinical trials across a broad range
of diseases, are pleased to share that significant progress has
been made in the single-arm, open-label compassionate
access1 trial of Psilocybin-Research Intervention with
Motivational Enhancement (PRIME) for substance use disorders.
Currently in the development stage, the PRIME study will assess the
efficacy and safety of psilocybin-assisted motivational enhancement
therapy.
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. Syreon is leading
the trial as Clinical Research Organization (CRO) with Numinus as
the trial sponsor.
Numinus is pleased to share that several key milestones have
been met since the trial was announced in November. The protocol is
now finalized, having gone through two rounds of external expert
peer review by a leading psychedelic research foundation. The
overall structure selected for this protocol is consistent with
current best practices developed internationally for
psilocybin-assisted treatment. The psilocybin administration will
occur in the context of a behavioural intervention consisting of
motivational enhancement therapy, which is a structured counseling
approach based on principles of motivational psychology and is
designed to produce rapid, internally motivated change.
"Syreon is pleased to partner with Numinus to conduct this
ground-breaking study in substance use disorders," says
Paul Keown, founder and CEO
of Syreon. "These are among the most complex and challenging
areas of modern healthcare, with enormous clinical and societal
consequences. Psilocybin is a promising new therapy for
personalized care in this field, and Numinus and Syreon combine the
deep medical knowledge and broad trial expertise required for
expert research in this expanding area of natural bioactive
therapeutics."
Numinus is also proud to announce the appointment of several key
members to the study, including Dr. Lindsay
Mackay, MD, CCFP, a clinician-scientist and addictions
specialist who has been selected as Principal Investigator. Dr.
Mackay is a graduate of the British Columbia Centre on Substance
Use, NIDA-funded International Collaborative Addictions Medicine
Research Fellowship, and has extensive experience in the
exploration of psychedelics and novel therapies as treatments for
mental health and addictions. Elena
Argento, PhD, MPH, has been appointed Co-Principal
Investigator. Argento works collaboratively with the BC Centre on
Substance Use to conduct and lead innovative research and
interventions in response to the overdose crisis and is a
Postdoctoral Researcher at the University of
British Columbia.
While psilocybin remains a restricted substance in Canada, the evolving regulatory landscape has
shown the potential to enable greater accessibility to
psilocybin-assisted psychotherapy, particularly in light of Health
Canada's recent announcement of its intention to revise the Special
Access Programme (SAP). The PRIME trial is expected to contribute
to the growing interest in expanding access to psilocybin-assisted
treatments.
"We have made important progress to develop the framework and a
team of experts to conduct this compassionate access trial that
will contribute meaningful insights to treatment methods for
individuals with opioid, stimulant and/or alcohol use disorders,"
said Dr. Evan Wood, Chief Medical
Officer, Numinus.
Several new objectives are underway in preparation for the
implementation phase, with Syreon, as CRO, initiating study
materials. Numinus will continue the ongoing establishment of
physical, technical, and human resource infrastructure to support
the Compassionate Access trial, with the aim of enabling wider
delivery through the SAP, if approved.
1 Health Canada
recommends compassionate access open-label clinical trials when
drug manufacturers anticipate exceptional demand for a drug, "to
meet the needs of patients not eligible for enrollment in other
pivotal trials" (Special Access Program for Drugs: Guidance
document for industry and practitioners, Published 2020-10-14).
This program is not related to the U.S. FDA Expanded Access
program, sometimes referred to as "compassionate use" or the
Breakthrough Therapy designation.
About Numinus
Numinus Wellness Inc. (TSXV:NUMI) is a health care and research
company creating psychedelic-centred solutions to treat mental
illness, substance abuse and trauma.
Numinus Health delivers treatments through clinics
and virtual services, with clinics in Vancouver and Montreal.
Numinus R&D develops clinical and therapeutic
protocols to use in treatments, in collaboration with research
partners and regulators.
Numinus Bioscience develops formulations and methods for
a safe supply, using Health Canada licences, scientific expertise
and cutting-edge technology.
Learn more at numinus.ca, and follow us on Facebook, Twitter,
and Instagram.
About Syreon Corporation
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
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, due
to inconsistent public opinion, perception of the medical-use and
adult-use marijuana industry, bureaucratic 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; and the need to secure and maintain corporate
alliances and partnerships, including with research and development
institutions, customers and suppliers. 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.
SOURCE Numinus Wellness Inc.