Numinus and Syreon Provide Psilocybin Compassionate Access Trial Update

Significant progress made as Numinus-sponsored PRIME study on psilocybin-assisted psychotherapy for opioid, stimulant and/or alcohol use disorders enters pre-implementation stage

Numinus Wellness Inc. (TSXV:NUMI) (OTCMKTS:LKYSF), a company creating an ecosystem of solutions centered on the research, development, and delivery of safe, evidence-based, accessible use of psychedelic-assisted psychotherapies, 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. 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.

Paul Keown, Founder and CEO of Syreon

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 Vancouver Coastal Health’s Regional Addiction Program and the BC Centre on Substance Use to conduct and lead innovative research and interventions in response to the opioid overdose crisis and is a Postdoc 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. 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.

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