Psychedelics, like psilocybin are going mainstream – and fast. Already, over the last few months, Denver, Oakland, and Santa Cruz have recently legalized its use. Joining them, Ann Arbor, Michigan lawmakers voted to decriminalize psilocybin mushrooms, as well. In addition, a ballot in Oregon could legalize its use by November 2020. “If the ballot measure is voted on and passed into law, it would "empower the Oregon Health Authority to set up all licensing, training, certification, and ongoing education requirements for psilocybin service centers and facilitators during a mandated two-year development process,” as noted by The Hill.
The best part -- such drugs are already proving to be a major game changer for millions of people all over the world. Countless studies are already proving such treatments can treat a host of mental issues, like obsessive-compulsive disorder, PTSD, opioid addiction, alcoholism, depression, anxiety, and eating disorders. Plus, with plenty of clinical trials supporting psychedelic treatments, it’s only a matter of time before big pharmaceutical companies begin to invest heavily, and incorporate psychedelics into their own drug pipelines.
Helping, Compass Pathways (NASDAQ:CMPS) just became the first psychedelic drug company to go public on a major U.S. exchange. Since moving, Compass now has a market cap of $1.25 billion, making it one of the most valuable psychedelic stocks in the world. That excitement is creating a substantial opportunity for companies like Revive Therapeutics Ltd. (CSE:RVV)(OTC:RVVTF), Mind Medicine Inc. (OTC:MMEDF), Numinus Wellness Inc. (TSXV:NUMI), HAVN Life Sciences Inc. (CSE:HAVN), and Mind Cure Health Inc. (CSE:MCUR).
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, is pleased to provide a corporate update on its psychedelics therapeutics programs specifically as it relates to the Company’s oral thin-film delivery system and clinical studies with psilocybin at the University of Wisconsin-Madison.
“We are expanding our product pipeline with a focus on psychedelic therapeutics incorporating our novel oral thin-film delivery technology with psilocybin, in which we have prototypes developed and we will move towards clinical studies with the University of Wisconsin-Madison along with other key industry partners,” said Michael Frank, CEO of Revive. “In addition, we are advancing our Phase I clinical study to evaluate the safety and feasibility of psilocybin in adults with Methamphetamine Use Disorder. Our initiatives in product development and clinical studies gives us a leading position in the psychedelic space.”
Psilocybin Oral Thin-film Product
Under its sponsored research partnership with the Reed Research Group out of the University of Wisconsin-Madison, the Company is developing its tannin-chitosan composite of orally dissolvable thin films which offers a unique delivery platform for therapeutic doses (1-20mg) of psilocybin into the oral cavity. The Company has received its final set of prototypes and is preparing to scale for manufacturing for future clinical studies involving psilocybin and other psychedelic-derived medicines. There are a number of advantages and benefits of an orally dissolvable psilocybin thin film such as the rapid dissolving and onset of action to the bloodstream, the ease and convenience for patients to administer without the need of water, chewing or swallowing, the potential of improved therapeutic outcomes and efficacy for underserved diseases and disorders including the flexibility to create accurate dosing and tasteful options.
The Company’s delivery technology is a natural, non-toxic, biodegradable and biocompatible composite that combines a tannin material, which is derived from a plant group having antibacterial, antifungal, antioxidant and wound healing properties, and a chitosan material, which is derived from the crustacean group having blood-clotting and antimicrobial properties. The delivery technology has a rapid onset of action and controlled or sustained release potential capabilities and may allow combining multiple extracts from mushrooms in one formulation.
Clinical Study of Psilocybin in the Treatment of Methamphetamine Use Disorder
The Company recently announced that it has entered into a Clinical Trial Agreement with the Board of Regents of the University of Wisconsin System to conduct a clinical study entitled “Phase I Study of the Safety and Feasibility of Psilocybin in Adults with Methamphetamine Use Disorder.” The Phase I study Principal Investigator is Dr. Christopher R. Nicholas, Ph.D., Assistant Professor of Program for Research Outreach Therapeutics and Education in the Addictions in the Department of Family Medicine and Community Health at University of Wisconsin School of Medicine and Public Health. 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. The Company will have exclusive access to key intellectual property from this study.
Other related developments from around the markets include:
Mind Medicine Inc. (OTC:MMEDF), the leading drug development company for psychedelic inspired medicines, announces that the company has been conducting R&D work on psilocybin in collaboration with the University Hospital Basel's Liechti Lab in a study to better understand and compare the altered states of consciousness induced by psilocybin and LSD. MindMed is interested in understanding how psilocybin or LSD affects humans differently so that it can design better later stage trials or potentially even combine substances in future next-generation psychedelic assisted therapies for patients. As part of MindMed's exclusive license agreement with the University Hospital Basel, MindMed will retain an exclusive license to all IP and any patents generated from data or findings in the study and related work on psilocybin, such as pharmacokinetic data and information on the metabolism. The study is anticipated to finish in Q2 2021.
Numinus Wellness Inc. (TSXV:NUMI), a company creating an ecosystem of health solutions centred on developing and supporting the safe, evidence-based, accessible use of psychedelic-assisted psychotherapies, is pleased to announce it has begun cultivating Psilocybe mushrooms , for the purpose of psilocybin production, at its 7000 square-foot Health Canada licensed facility. Psilocybin-assisted psychotherapy is currently being studied as a treatment for a range of mental health conditions including depression, anxiety, and substance use disorders.
HAVN Life Sciences Inc. (CSE:HAVN) a biotechnology company focused on unlocking human potential using evidence-informed research and developing standardized psychoactive compounds derived from plants and fungi, is pleased to announce it has submitted formulations for its natural health products to Health Canada . “At Havn Life we are focused on developing Natural Health Products for Havn Retail that build on and complement the work being done in our Havn Labs division with psychedelic compounds,” Gary Leong, Havn Life’s Chief Scientific Officer. Leong formerly served as Chief Scientific Officer for natural health manufacturer, Jamieson Laboratories Limited, for fourteen years and with Aphria Inc., where he established and oversaw the quality assurance, quality control, regulatory affairs and research and development functions.
Mind Cure Health Inc. (CSE:MCUR) a mental health and wellness company with a mission to identify, develop and commercialize products that enhance mental health and wellness, ease suffering and increase productivity, is pleased to announce that, further to its news release dated September 17, 2020, its common shares will resume trading on the Canadian Securities Exchange under the ticker symbol "MCUR" effective September 21, 2020. Mind Cure's common shares were listed on the CSE effective September 17, 2020 and halted pending the completion of its initial public offering. Philip Tapley, Chairman, President, and CEO stated, "This is a significant event in the Company's history and we are looking forward to expeditiously build our senior operational and product management team, enhance and accelerate our marketing plan, and expedite our efforts to identify and evaluate new potential product candidates in addition to our Moonbeam Mushrooms product line."
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