The psychedelics boom is alive and well thanks in part to a landmark decision on psilocybin mushrooms. Just days ago, the Canadian government allowed four terminally ill patients with cancer to receive psilocybin therapy to help ease end-of-life distress. This is the first time in 46 years that an exemption has been given in Canada for patients to access such treatment, says CNN. From here, such treatments could grow in popularity as research shows it can help relieve anxiety and depression in patients with advanced forms of cancer. In addition, according to study out of NYU Langone Health, of 29 cancer patients treated with a single dose of psilocybin, about 60% to 80% showed a reduction in distress.
At the same time, psilocybin is finding broader support in the U.S. For example Denver, Oakland, and Santa Cruz have recently legalized its use. Washington, D.C. and Oregon residents will vote on its legalization in the upcoming November 2020 elections. With the psilocybin story booming, some of the top companies to watch as the psychedelics boom just gets under way include Revive Therapeutics (CSE:RVV)(OTC:RVVTF), Mind Medicine Inc. (OTC:MMEDF), Johnson & Johnson (NYSE:JNJ), Numinus Wellness Inc. (TSXV:NUMI), and GW Pharmaceuticals (NASDAQ:GWPH).
Revive Therapeutics Ltd. (CSE:RVV)(OTC:RVVTF) BREAKING NEWS: Revive Therapeutics Ltd., a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, announced an expansion to the sponsored research partnership agreement entered with the University of Wisconsin-Madison to evaluate novel formulations of psilocybin and a planned Phase 1 clinical study investigating the therapeutic application of psilocybin for an undisclosed addiction use disorder.
“We are pleased to have expanded our research partnership with the University of Wisconsin-Madison in the development of novel psilocybin formulations that will serve as the platform to create unique psychedelic-based therapeutics for clinical research targeting specific medical needs, such as addiction use disorders,” said Michael Frank, Revive’s Chief Executive Officer. “As part of our psychedelic-based pharmaceutical strategy, we are focused on balancing research and development of novel psilocybin-based formulations and clinical research of psilocybin to create a robust product pipeline backed by intellectual property and clinical data with the aim to pursue the FDA regulatory pathway for commercialization. Revive plans to expand its clinical development pipeline with psilocybin for various addiction and dependence disorders.”
The research and development work being carried out at the University of Wisconsin-Madison focuses on tannin-chitosan composites in the form of thin films, hydrogels and 3D foams. The research will include the development of composite formulations, physio-chemical characterization (e.g. tensile strength of films) of composite materials and rate of psilocybin release from composites. Final formulations will be investigated in pre-clinical and clinical studies in various diseases and disorders. The Company has identified tannin-chitosan composite thin films as the lead candidate for the development of a unique delivery platform for therapeutic doses (1-20mg) of psilocybin into the oral cavity.
The Company also plans to finalize a sponsorship program around a Phase 1 clinical study examining psilocybin for the treatment of an undisclosed addiction use disorder. The clinical study will be conducted at the University of Wisconsin-Madison, School of Medicine and Public Health, and School of Pharmacy, which holds a Wisconsin special authorization and DEA license to perform clinical research with psilocybin.
Other related developments from around the markets include:
Mind Medicine Inc. (OTC:MMEDF) the leading psychedelic pharmaceutical company, has engaged renowned psychedelic assisted therapy expert Dr. Peter Gasser as an advisor to its LSD experiential therapy program Project Lucy. Dr. Gasser has pioneered the legal, medical use of psychedelics through clinical research and compassionate access in Switzerland. Dr Gasser has served as the President of the Swiss Medical Society for Psycholytic Therapy since 1997. Through compassionate access in Switzerland, Dr Gasser holds several individual treatment permissions to treat patients with MDMA and LSD. Dr. Gasser and University Hospital Basel’s Dr Matthias Liechti are conducting a Phase 2 trial of LSD assisted therapy for anxiety disorders. MindMed previously acquired the exclusive license to this ongoing Phase 2 trial through its collaboration agreement with the University Hospital Basel.
Johnson & Johnson (NYSE:JNJ) announced its Janssen Pharmaceutical Companies have entered into an agreement with the U.S. government for the large scale domestic manufacturing and delivery in the U.S. of 100 million doses of Janssen’s SARS-CoV-2 investigational vaccine, Ad26.COV2.S, for use in the United States following approval or Emergency Use Authorization by the U.S. Food and Drug Administration (FDA). The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, in collaboration with the U.S. Department of Defense, is committing over $1 billion for this agreement. The vaccine will be provided at a global not-for-profit basis for emergency pandemic use. The U.S. government may also purchase an additional 200 million doses of Ad26.COV2.S under a subsequent agreement.
Numinus Wellness Inc. (TSXV:NUMI), a company creating an ecosystem of health solutions centered around developing and supporting the safe, evidence-based, accessible use of psychedelic-assisted therapies, is pleased to announce its partnership with Together We Can Addiction Recovery and Education Society (TWC). TWC is one of Canada's largest addiction treatment organizations, a registered charity, licensed healthcare provider, and an approved Canadian Federal Government service provider for the veterans' community. The partnership has enabled TWC to enhance its mental health and addiction recovery support services with tailored mind/body wellness programs. Numinus's associated wellness clinic is benefitting from the partnership with a dedicated stream of revenue, reinitiated since the clinic's re-opening post-COVID earlier this month. The active service provider partnership is designed to ultimately support psychedelic-assisted therapies when authorized for use in Canada. One in five Canadians suffer from addiction in any given year, and deaths from the current overdose crisis attributable to opioid and other addictions are growing. Numinus and TWC share the view that new solutions and integrative approaches are needed to enhance traditional recovery-based approaches to help people make transformative change, heal, and be well. The partnership currently extends the continuum of care provided to TWC clients with specialized mind/body programs which include modalities such as naturopathy, registered massage therapy, trauma and somatic therapies, and breathwork through Numinus's associated wellness clinic in Vancouver. Individualized programs are continually being developed for TWC clients, including Canadian Forces members and veterans dealing with addiction, PTSD, anxiety, grief and loss, and other diagnoses.
GW Pharmaceuticals (NASDAQ:GWPH), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, announced financial results and operating progress for the second quarter ended June 30, 2020. “We were pleased with the strength of U.S. Epidiolex sales in the second quarter in spite of the COVID-19 pandemic. Further, the recent approval and imminent launch of Epidiolex for the treatment of seizures associated with TSC provides a meaningful new opportunity to accelerate momentum through the second half of 2020 and beyond,” stated Justin Gover, GW’s CEO. “We also continue to be excited about the potential of our product pipeline, in particular nabiximols, for which we recently outlined our accelerated US development strategy in the treatment of spasticity in patients with MS and other conditions. We look forward to commencing the nabiximols Phase 3 program as well as multiple other pipeline clinical trials in the second half of the year.”
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