MIAMI, March 22, 2021 (GLOBE NEWSWIRE) -- 20/20 Global, Inc. dba Mycotopia Therapies, (OTC Pink: TWGL) (the “Company”), a company focused on psychedelic therapies, announced today it has formed PsyBioMed – Australia and entered into a letter of intent to jointly conduct clinical trials in Australia using psychedelics to treat mental illness. PsyBioMed – Australia will be a joint venture between Mycotopia Therapies and Melbourne, Victoria based psychedelic research and development company Natural MedTech. It is expected that PsyBioMed-Australia will build and develop a R&D laboratory and a manufacturing facility in Victoria using technology to be provided by Ehave, Inc. (OTC: EHVVF) to capture and analyze data.
According to data released by the Australian Institute of Health and Welfare 4.3 million Australia patients (17.1% of the Australian population) received a mental health-related prescription in 2018–19 with 70.9% (27.6 million) of those being antidepressant medications. With anti-depressant usage on the rise over the years and currently with over 3 million Australians on anti-depressants, there are hundreds of thousands of patients that meet the criteria for psychedelic assisted therapies in Australia. PsyBioMed aims to close the loop in the broken supply chain and produce Current Good Manufacturing Practice (cGMP) psychedelics in Australia, while researching various other molecules that can be translated into clinical practice.
Medically supervised, legal access to evidence-based Psychedelic-Assisted Psychotherapy is becoming increasingly available through clinical trials for multiple conditions throughout Australia. The Australian government through the Medical Research Future Fund (MRFF) has allocated $15 million to fund clinical research into Ketamine, Psilocybin and MDMA Assisted therapies in order to fully ascertain the safety and impacts of these kinds of drugs compared to existing drugs. This research by the Australian government into whether psychedelic drugs are more effective than existing treatments sets the stage for large-scale clinical trials.
PsyBioMed-Australia intends to obtain licences and permits to legally possess, supply, sell and manufacture Schedule 8 & 9 Drugs (Schedule 9 is equivalent to America’s Schedule 1) in order to produce cGMP psychedelics in Australia. PsyBioMed-Australia’s Victoria, Australia based facilities will have the capabilities to undertake genetic approaches and apply both mycology and synthetic biology techniques in both R&D and full GMP environments. PsyBioMed-Australia plans to produce medicine at a standard for human consumption, develop IP and supply upcoming clinical trials, as well as health institutions and physicians when appropriate.
The partnership with Natural MedTech provides PsyBioMed access to various forms of intellectual property, an expert team of local scientists, medical professionals, university, and industry partners that are pioneers in their respective fields and are passionate about developing novel therapies for the unmet need that is mental ill health.
Mycotopia Therapies, through its relationship with Ehave, provides PsyBioMed with IP access to digital therapeutic blockchain technology that allows for the secure and compliant capture of in-depth data sets. This data capture will be used to clinically validate some of these more experimental forms of therapy including psychedelic and ketamine treatments whilst allowing patients to own their own data and do what they want with it.
This type of data capture will allow for effective N-of-1 type studies in alignment with the Royal Australian and New Zealand’s College of Psychiatrist Clinical Memorandum – Therapeutic use of psychedelic substances.
Ben Kaplan, CEO of Mycotopia Therapies, said, “It is estimated 4 million Australians experience a mental health disorder every year, and almost half of all Australians will be affected at some point in their lifetime. PsyBioMed-Australia will provide the opportunity to boost local research into potentially lifesaving therapies while creating a supply chain for their distribution.”
Dr. Manideep Gopishetty, CMO of Mycotopia Therapies, said, “Increasing research evidence suggests MDMA, commonly known as ecstasy, could be an effective adjunct to psychotherapy for people with post-traumatic stress disorder (PTSD). Meanwhile, clinical trials of psilocybin, the psychoactive component of magic mushrooms, show it could assist psychotherapy in the treatment of anxiety, depression, addiction and other mood-based disorders all of which aligns with our research and drug development roadmap. We strongly believe Australia would be a pivotal point for global distribution of psychedelics and special access program of Australia designed for medical consumption of psychedelics in chronic mental health conditions is a perfect model created by the Australian government to enable this drug delivery process very seamlessly by having all regulatory protocols in place.”
Mark Hestermann, CEO of Natural MedTech, said, “Australia is often considered a lucky country, but we have one of the highest rates of mental ill health globally. Something is wrong. I believe that people deserve better than to live with symptom management when there are more promising treatment options at our doorstep. Our mission is to break the symptom management cycle that’s all too prevalent in mental healthcare and offer alternative and meaningful solutions for people who are suffering.”
Dr Jamie Rickcord, Founder of Ananda Clinics, said, “In order for us to safely introduce psychedelic assisted therapy into Australian practice, having access to GMP grade psychedelic medicines is an urgent need. Recent announcements from the Australian government of $15 million to fund research into psychedelic therapies highlights the need for these medicines to be available. Australia will soon be on the leading edge of the renaissance and as we build data and experience in psychedelic medicine it will be another leap to have access to locally produced medicines. The combination of local research and production will allow suffering Australian's to access these therapies safely and in timely manner. This partnership is the innovation and forward thinking required at this crucial stage in the introduction of psychedelic medicine in Australia.”
About Mycotopia Therapies
Mycotopia Therapies focuses on helping you heal and reclaim your life. Your journey of healing is an understanding of the causes and works to mental wellness through psychedelic enhanced psychotherapy, integrated with a professional team of mental wellness practitioners and cutting-edge technology. Psychedelic therapy is a holistic and spiritual approach providing healing and has shown successful treatment for many years. Additional information on Mycotopia Therapies can be found on the Company’s website at: https://www.mycotopiatherapies.com.
About Natural MedTech
Natural MedTech is a biotech company driven by a passion to bring optimum health and wellness by translating modern advancements into meaningful action. Natural MedTech conducts drug development, engages and supports clinical trials with the goal of advancing clinical application of psychedelics and other scheduled compounds of therapeutic relevance. Our initial focus is to manufacture GMP psilocybin in Australia and provide innovative solutions to address current public health challenges of today.
We are focused on psychedelic advancements, but we understand that psychedelics aren’t the whole picture. Natural MedTech promotes its Seven (7) pillars of health, which are in Personalized Nutrition, Exercise, Personalized Medicine, Mindfulness Meditation, Breathwork, Sleep, and Psychedelic Medicines. https://www.naturalmedtech.com
Forward-Looking Statement Disclaimer
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements: (i) the initiation, timing, progress and results of the Company’s research, manufacturing and other development efforts; (ii) the Company’s ability to advance its products to successfully complete development and commercialization; (iii) the manufacturing, development, commercialization, and market acceptance of the Company’s products; (iv) the lack of sufficient funding to finance the product development and business operations; (v) competitive companies and technologies within the Company’s industry and introduction of competing products; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) loss of key management personnel; (viii) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its products and its ability to operate its business without infringing the intellectual property rights of others; (ix) potential failure to comply with applicable health information privacy and security laws and other state and federal privacy and security laws; and (x) the difficulty of predicting actions of the USA FDA and its regulations. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement unless required by law. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is contained under the heading "Risk Factors" in 20/20 Global, Inc.’s Registration Statement on Form F-1 filed with the Securities and Exchange Commission (SEC) on September 24, 2015, as amended, which is available on the SEC's website, http://www.sec.gov.
Contact for 20/20 Global and Ehave
Media Inquiries: Gabe Rodriguez
Phone: (623) 261-9046