Psychedelic medicine is emerging as a breakthrough for mental health. After decades of research, drugs like psilocybin and ketamine are finally ready to move from the lab into the pharmacy and the therapist’s office. Several psychedelic treatments have already received approval from the US Food and Drug Administration (FDA), including Johnson & Johnson’s (NYSE:JNJ) ketamine-life depression drug, and more are likely to follow suit in the years to come. Now that the FDA has come to realize the potential benefits of psychedelic medicines, pioneering biotechnology companies have the opportunity to take the progress made by researchers and transition it into market-ready pharmaceutical products. Companies like Mydecine Innovations Group Inc. (OTC:MYCOF) (CSE:MYCO), Mind Medicine (MindMed) Inc. (NEO:MMED) (OTC:MMEDF), COMPASS Pathways plc (NASDAQ:CMPS), Numinus Wellness Inc. (TSXV:NUMI) (OTCPK:LKYSD), and Champignon Brands Inc. (OTC:SHRMF) (CSE:SHRM).
Mydecine Innovations Group Inc. (OTC:MYCOF) (CSE:MYCO) is an emerging biopharma and life sciences company that is committed to the research, development, and acceptance of alternative nature-sourced medicine. Through its portfolio of companies and experienced leadership team, Mydecine Innovations is looking to provide the mental health industry with innovative solutions.
Health Crisis Highlights Growing Need for Alternative Treatments for Mental Illness
Since the start of the global pandemic, the healthcare system has taken a beating as frontline workers struggled to keep up with the rising cases while still providing care for those with other illnesses. The crisis has also led to an all-time high in anxiety and depression in the US, with 47.1 million Americans (19%) now living with a mental health condition, including front line workers, who are also at a higher risk of developing post-traumatic stress disorder (PTSD).
Mydecine Innovations Group Inc. is looking to tackle the problem from all angles through its clinical trials and digital mental health platform. On November 17, Mydecine announced the international expansion of its Phase 2A clinical trials of psilocybin-assisted psychotherapy to treat chronic PTSD in veterans and emergency medical services (EMS) personnel.
The trials, which will take place at prominent medical centers in Ontario, Alberta, the Netherlands, along with four other trial sites developing in the US and the UK, will be used to explore how the brain responds to psychedelics and develop a better understanding of the biological underpinnings of the experience. Mydecine Innovations plans to use the data from the studies to build on its data in the hopes of receiving FDA breakthrough designation.
The company also bolstered its leadership team with the appointment of its new Chief Medical Officer, Dr. Rakesh Jetly, a medical advocate for the use of psychedelic-assisted psychotherapy and a prominent voice in the fight against PTSD and other mental health issues.
Apart from its efforts to cultivate and develop psychedelic therapies to combat mental illness, Mydecine Innovations has launched a mental health-focused telehealth digital platform to assist therapy patients with psychedelic aftercare, track moods, and combat addiction. Mindleap, which is available on iOS and Android, is an AI-powered first-to-market digital health platform designed by clinical psychologists and neuroscientists that combines telehealth with mood, emotion, and habit tracking.
The Mindleap Health app allows Mydecine to increase access to much-needed mental health services, while at the same time gaining a piece of the growing telehealth industry, which is projected to become a $560 billion market by 2027.
Mydecine Innovations is preparing to start its Phase 2a clinical trials of psilocybin-assisted psychotherapy to treat chronic PTSD in veterans and EMS personnel. The trials will be conducted at Leiden University Medical Centre in the Netherlands, the University of Western Ontario, and the University of Alberta, but the company is also exploring additional trial sites across North America including Los Angeles, New York, Boston, and Ottawa.
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FDA Gives Green Light to Psychedelic-Based Treatments for Depression
The psychedelic medicine market has come a long way in the last couple of years, with regulators jumping on board and fast-tracking novel treatments based on a variety of psychedelics, and companies getting the go-ahead to do more in-depth research into psychedelics.
Mind Medicine (MindMed) Inc. (NEO:MMED) (OTCQB:MMEDF) announced earlier this month that the company completed the Phase 1 LSD study in partnership with University Hospital Basel’s Liechti Lab in Switzerland. MindMed is now preparing for Phase 2b of Project Lucy, which intends to evaluate the efficacy of LSD-assisted therapy for anxiety disorders and other medical conditions. The Phase 1 study used a double-blind, randomized, placebo-controlled, crossover design in 16 healthy participants to measure LSD dose-dependently induced subjective responses starting at microdoses (25 ug) up to experiential doses (200 ug). Apart from preparing for Phase 2b, MindMed and University Hospital Basel are also actively filing patent applications on clinical trial data generated through its clinical trials and R&D.
COMPASS Pathways (NASDAQ:CMPS) was given breakthrough therapy designation from the FDA for its psilocybin therapy for treatment-resistant depression. Earlier this year the company announced that it has been granted US Patent No 10,519,175, relating to methods of treating drug-resistant depression with a psilocybin formulation, by the US Patent and Trademark Office. The patent covers the use of COMPASS’s synthesized investigational psilocybin formulation, COMP360, in a psilocybin therapy protocol for patients with treatment-resistant depression. Psilocybin is an active ingredient in so-called ‘magic mushrooms’.
Numinus Wellness Inc. (TSXV:NUMI) (OTCPK:LKYSD) became the first publicly-traded company in Canada to be granted a license by Health Canada to conduct research to standardize the extraction of psilocybin from mushrooms. Back in June, the company announced that it has received Health Canada approval to amend the Company’s existing License under the Controlled Drug and Substances Act to allow Numinus researchers to conduct research to standardize the extraction of psilocybin from mushrooms. The amendment means Numinus is the first publicly-traded company in Canada to be granted a license by Health Canada to conduct research of this kind.
Champignon Brands Inc. (OTCQB:SHRMF) (CSE:SHRM) announced earlier this year that it continues to augment its Special Advisory Committee with the addition of key individuals experienced in highly regulated industries primed for rapid growth. To this accord, the Company is pleased to announce the appointment of Mr. Jay Kheita, ACPR, to its Special Advisory Committee, where he will help lead the integration of Champignon’s novel and natural treatment protocols into its existing consumer packaged goods portfolio. Champignon’s Special Advisory Committee continues to evaluate the potential positive effects of its novel and natural treatment protocols and ongoing preclinical trials on individuals suffering from indications such as depression, post-traumatic stress disorder (PTSD), traumatic brain injuries (TBI), obsessive-compulsive disorder (OCD), as well as substance and alcohol use disorders.
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