Numinus Announces Milestones in MAPS-Sponsored MDMA-Assisted Therapy Clinical Trial for PTSD

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 recruit 30 people with opioid, stimulant and/or alcohol use disorders. Syreon is leading the trial as a clinical research organization (CRO) with Numinus as the trial sponsor.

Numinus is pleased to share that several key milestones have been achieved since the start of the trial announced in November . The protocol is now finalized, having undergone two rounds of external expert reviews 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 administration of psilocybin will take place as part of a behavioral intervention consisting of motivational enhancement therapy, which is a structured counseling approach based on the principles of motivational psychology and designed to produce rapid and motivated change. internally.

“Syreon is thrilled to partner with Numinus to conduct this groundbreaking 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 area, and Numinus and Syreon combine the knowledge extensive medical and testing expertise necessary for research in this rapidly expanding field of natural bioactive therapeutics.”

Numinus is also proud to announce the appointment of several key study members, including Dr. lindsay mackay , MD, CCFP, clinician-scientist and addiction specialist who was selected as the principal investigator. Dr. Mackay is a graduate of the British Columbia Center on Substance Use, funded by the NIDA International Collaborative Addictions Medicine Research Fellowship, and has extensive experience in exploring psychedelics and novel therapies as treatments for mental health and addictions. Elena Argento , PhD, MPH, was named co-principal investigator. Argento works collaboratively with the BC Center on Substance Use to conduct and lead innovative research and interventions in response to the overdose crisis and is a postdoctoral fellow at University of British Columbia .

Although psilocybin remains a restricted substance in Canada , the evolving regulatory landscape has shown the potential to allow greater accessibility to psilocybin-assisted psychotherapy, particularly in light of Health Canada’s recent announcement of its intention to revise the Special Access Program (SAP). The PRIME trial is expected to contribute to the growing interest in expanding access to psilocybin-assisted treatment.

“We have made significant progress in developing the framework and a team of experts to conduct this compassionate access trial that will yield meaningful insights into treatment methods for people with opioid use disorders, stimulants and/or alcohol,” said Dr. Evan Wood , Chief Medical Officer, Numinus.

Several new lenses are being prepared for the implementation phase, with Syreon, as CRO, initiating study materials. Numinus will continue the ongoing establishment of the physical, technical and human resources infrastructure to support the compassionate access trial, with the aim of enabling broader delivery via SAP, if approved.

1 Health Canada recommends open, compassionate-access 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 medicines: guidance document for industry and practitioners, published in 2020 -10-14 ). This program is not related to the US FDA’s Expanded Access Program, sometimes referred to as “compassionate use” or the Breakthrough Therapy designation.

About Numinus

Numinus Wellness Inc. (TSXV: NUMI) is a healthcare and research company that creates psychedelic-centric solutions to treat mental illness, addiction and trauma.

Numinus Health offers treatment through virtual clinics and services, with clinics in Vancouver and Montreal .

Numinus R&D develops clinical and therapeutic protocols for use in treatments, in collaboration with research partners and regulators.

Numinus Biosciences develops formulations and methods for safe supply, using Health Canada licenses, scientific expertise and state-of-the-art technology.

Learn more about numinus.ca , and follow us on Facebook , Twitter , and instagram .

About Syreon Corporation
Syreon offers a comprehensive suite of adaptive clinical trials, health economics and outcomes research ensuring the safe, effective and value-driven clinical use of innovative therapies in more than 40 countries.

Syreon partners with an elite portfolio of global pharmaceutical companies and early-stage biotechnology companies to accelerate the evaluation of new therapies and improve health outcomes. Its expert research services identify specific 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 breakthrough innovations, from early blockers, chimeric and humanized monoclonals, recombinant human proteins and companion diagnostics to the developing fields of immuno-oncology, cell therapy strains and other recent initiatives in precision medicine.

Syreon’s head office 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, suppliers, buyers and payers. Our services in all phases of study planning, execution, analysis and reporting ensure safe, efficient and value-driven clinical use.

www.syreon.com

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SOURCE Numinus Wellness Inc.

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