Mental health support is not as strong as it should be for Canadians. At the moment, an overburdened system, structural gaps and ineffective medications with potential debilitating side effects can actually more harm than good. However, according to Numinus Wellness (TSXV:NUMI)(OTC:LKYSF), there are other options. One of those options includes psychedelic-assisted psychotherapy, which bridges the gap as an interventionist method of care for those with polysubstance abuse issues, for example.
In fact, Numinus Wellness’ psilocybin study trials are already showing promise for being an important part of the continuum of treatment for substance use disorders, including opioids. It may also have the potential to help people address and overcome the root of their addiction.
Numinus Wellness and Syreon Corporation Have Made Significant Progress
Numinus Wellness, 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 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.
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.
Other related developments from around the markets include:
Mind Cure Health Inc. (CSE:MCUR)(OTC:MCURF) announced that it has completed beta testing of its proprietary bioinformatics platform PsyCollage, achieving its Q1 testing milestone. Bioinformatics is an interdisciplinary field that develops methods and software tools for understanding biological data with large and complex data sets. MINDCURE's first-generation bioinformatics platform resides within the Company's Product Discovery sphere, led by Chief Scientific Officer, Dr. Ryan Hartwell. PsyCollage will be used to drive decision-making using predictive correlative statistical analytics of documented research in psychedelics. PsyCollage has evolved through its development into a turnkey (database/data mining) resource for discovery and analysis of target receptors, methods, and historical clinical trial data. It is a valuable resource for mapping strategic business partnerships in the psychedelic community.
Seelos Therapeutics Inc. (NASDAQ:SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, announced an amendment of the agreement with Vyera Pharmaceuticals AG for the development of SLS-002 (intranasal racemic ketamine) to repurchase in cash a significant portion of the royalties payable on any future net sales of SLS-002. On March 6, 2018, Seelos entered into an asset purchase agreement with Vyera, currently known as Phoenixus AG, to acquire the assets and liabilities of Vyera's intranasal racemic ketamine program, which Seelos now calls SLS-002. As additional consideration to certain upfront cash and equity payments and success-based milestone payments contemplated under the prior agreement, Seelos agreed to pay a mid-teens percentage royalty on any future net sales of SLS-002.
Mindset Pharma Inc. (CSE:MSET), a drug discovery and development company focused on developing next generation psilocybin-inspired medicines and related technologies, is pleased to announce that it has engaged a leading international contract development and manufacturing organization to synthesize a 1.0 kg batch of cGMP (i.e. pharmaceutical grade) psilocybin utilizing Mindset's innovative and cost-effective patent-pending synthesis process. The large scale cGMP synthesis batch is expected to be released in the fall of 2021. Mindset anticipates that there will be significant demand for its proprietary, high-quality psilocybin supply given the increasing number of trials and studies underway utilizing psilocybin. High-quality psilocybin for clinical research purposes is currently expensive and difficult to procure, however Mindset's cost-effective patent-pending synthesis process provides Mindset with a unique advantage to accelerate the commercialization of its portfolio of intellectual property. Several CDMOs that specialize in psilocybin synthesis have exclusive relationships with individual clients, further narrowing the range of psilocybin supply options. Additionally, Mindset is not aware of any existing psilocybin suppliers that have synthesized a commercial quantity at a scale exceeding 1.0kg.
XPhyto Therapeutics Corp. (CSE:XPHY)(OTC:XPHYF) is pleased to announce that XPhyto Laboratories Inc., its wholly owned Alberta subsidiary, has added mescaline production to its psychedelic medicine programs. Further to the Company’s press release dated February 3, 2021, the capacity under contract with Applied Pharmaceutical Innovation will focus on the synthesis of pharmaceutical grade mescaline. Mescaline has been anecdotally recognized as a relatively safe psychedelic drug and has shown particular promise for the treatment of addiction and depression. “In addition to our European-based psilocybin biotechnology production, the Company has now expanded its portfolio of psychedelic compounds to include mescaline. Our goal is to develop industrial scale production processes for the wholesale market and for incorporation into XPhyto’s thin film drug delivery platforms,” commented Hugh Rogers, CEO & Director. “We see a significant market opportunity in the production of pharmaceutical mescaline and the standardization of dosage formulations with precise, predictable and efficient drug delivery for clinical study and therapeutic use.”
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