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New York, NY – September 7, 2022 – According to a new survey by Johns Hopkins Medicine researchers, people’s attitudes toward death change after a psychedelic drug experience and a non-drug-related out-of-body experience. The researchers divided more than 3,000 participants into two groups: those who had already had an extraordinary drug-free experience and those who had used a psychedelic drug: psilocybin (found in magic mushrooms), lysergic acid diethylamide (LSD), ayahuasca or N,N-dimethyltryptamine (DMT). They found that about 90% of people in both groups feared death less than before their experiences. These findings are based on previous research demonstrating that psychedelics can relieve end-of-life anxiety, especially when combined with therapy. Companies developing psychedelic-based treatments include Optimi Health Corp. (CSE:OPTI) (OTCQX:OPTHF), Compass Pathways (NASDAQ:CMPS), Mind Medicine (MindMed) Inc (NASDAQ:MNMD) (NEO:MMED), Cybin Inc (NYSE:CYBN) (NEO:CYBN), and Enveric Biosciences (NASDAQ:ENVB).
Optimi Health Corp. (CSE:OPTI) (OTCQX:OPTHF) is a homegrown Canadian company producing natural, scalable and accessible psychedelic and functional mushrooms and synthetic formulations for transformational human experiences. The company is on Health Canada’s list of approved suppliers under the Special Access Program (SAP), which allows medical practitioners access to Schedule 3 controlled substances like psilocybin on a case-by-case emergency basis.
Optimi has continued to expand its business through strategic partnership and supply agreements. On September 7, the company announced that it has signed its first large-scale international mushroom supply agreement with Avida Global, a privately-held UK-based producer of high-quality wellness products, including nutraceuticals and medicinal cannabis oils.
Through the agreement, Optimi will supply Avida with an extensive catalog of Optimi Life functional mushroom formulations, which will be available for distribution to clients and partners worldwide through Avida’s white-labelling and manufacturing business, Avida Labs.
This is an exciting opportunity when you consider that Europe’s functional mushroom market is expected to grow at a CAGR of 5.6% from 2021 to 2028 to reach US$107 million by 2028. At the same time, the UK market is forecast to grow at a CAGR of 7.5% between 2021 – 2027.
Earlier this month, Optimi Health provided an operational update on the progress of its planned marketing year.
The year of commercialization, which began in Q1 2022, is a strategic growth strategy meant to scale all areas of Optimi Health‘s income production in accordance to market demand for natural psychedelic and functional mushrooms, as well as synthetic psychedelic compounds.
Since the opening of its Princeton, B.C. cultivation and processing facility, Optimi Health has secured five domestic psilocybin supply agreements with Bloom Psychedelic Therapy and Research Centre, Filament Health, ATMA Journey Centers, SABI Mind, and Halucenex Life Sciences, as well asl one international psilocybin supply agreement with Promises Innovative Recovery Center.
The company also inked retail and e-commerce distribution agreements with Well.ca, Healthy Planet, and Vitasave for its Optimi Life line of functional mushroom formulations and supplements.
On August 10th, the Company partnered with Canadian psilocybin patient advocate Thomas Hartle to create Blue Serenity, Canada’s first therapeutic psilocybin product for use by approved patients and research entities. Blue Serenity, and other Optimi product offerings, will be featured in the company’s upcoming psilocybin product catalogue, to be launched in September 2022.
And that’s not all. Optimi Health recently received an amendment to its Health Canada Controlled Substances Dealers Licence to manufacture and distribute synthetic psychedelics, with a focus on MDMA. Large-scale production of MDMA is scheduled to begin in October 2022 and domestic and international supply agreements are anticipated for later this year and into 2023.
The company also spoke about the Biden administration’s recent disclosure that FDA approval for psychedelic therapy is expected within 24 months, as well as an August 25th meeting between Canadian Health Minister Carolyn Bennet and members of the Oregon Psilocybin Advisory Board, indicate that the regulatory landscape in psychedelics is poised for rapid advancement.
“With policymakers increasingly aligning around psychedelic therapy and a robust commercial sector developing to meet the challenge of delivering better health outcomes with these substances, Optimi is building a global distribution pipeline and is positioned to be the leader in psychedelic drug supply,” said Optimi Health CEO Bill Ciprick.
Psychedelics Companies Are Progressing With Clinical Trials
Compass Pathways (NASDAQ:CMPS), a mental health care company focused on accelerating patient access to evidence-based innovation, has several studies and trials underway. In August, the company reported its Q2 financial results and business highlights, which included launching a Phase II study in anorexia nervosa for its COMP360 psilocybin therapy and an investigator-led study in adults with autism spectrum disorder (ASD) and expanding its Phase II trial in post-traumatic stress disorder (PTSD). Compass Pathways also submitted phase II protocols for COMP360 psilocybin therapy in treatment-resistant depression (TRD) to the FDA, which is now under review. The company expects the program to begin in Q2 2022.
On August 25, Mind Medicine announced the first patient dosing in its Phase 2b dose optimization trial of MM-120, a pharmaceutically optimized form of lysergic acid diethylamide (LSD), for the treatment of generalized anxiety disorder (GAD). The Phase 2b trial is a multi-center, randomized, parallel, double-blind, placebo-controlled, dose-optimization study. The trial will enroll 200 participants that will be given a single administration of up to 200 µg of MM-120 or placebo. The primary objective is to determine the reduction in anxiety symptoms four weeks following the single administration of MM-120, compared across the five treatment arms.
Cybin Inc (NYSE:CYBN) (NEO:CYBN) announced on August 30 that the first two participants have received a dose in its phase 1/2a trial evaluating CYB003 for the treatment of major depressive disorder (MDD). CYB003 is designed to address the challenges and limitations of oral psilocybin potentially. Based on preclinical data, CYB003 achieved less variability in plasma concentrations, faster onset of action and shorter duration of effect. These preclinical data demonstrated that CYB003 has the potential to reduce the burden of time and resources for patients, providers and payers and possibly improve treatment scalability and accessibility. On August 31, Cybin announced that Adelia Therapeutics Inc., a wholly owned subsidiary of Cybin, has achieved its final milestone, identified as Y2, Q4.
Enveric Biosciences (NASDAQ:ENVB), a neuroscience-focused biotechnology company developing next-generation, psychedelic-inspired mental health medicines, just announced that its president and COO Avani Kanubaddi will attend the H.C. Wainwright’s 24th Annual Global Investment Conference to be held at the Lotte New York Palace Hotel in New York City from September 12-14. Enveric Biosciences also recently appointed three new independent directors: Michael D. Webb, President and CEO of CXL Ophthalmics, Bevin O’Neil, Chief Strategy Officer of ECRI, and Frank Pasqualone, recently retired Chief Commercial Officer of Theravance, to its board of directors.
Optimi Health Corp.’s products are grown at its two facilities totaling 20,000 square feet in Princeton, BC, making it the largest grower of psilocybin and MDMA in North America.
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