Psychedelics Begin Gradual Climb to Medical Status

NEW YORK, May 26, 2020 /PRNewswire/ -- The fast pace of technological development in the biotechnology industry and the shifting market demands require continuous innovation. This, in turn, puts pressure on companies to invest vast resources in research and development. As a result, there were several innovative achievements scientists and researchers have made in biotechnology in recent years. Among the fields of study are gene editing, tissue engineering and regeneration, nanobiotechnology and others. However, there are also entire new segments which have emerged in the field of medicine. For example, the medical cannabis segments or the rising acceptance of psychedelic products used as a treatment for various health conditions including depression, panic disorders, post-traumatic stress disorder (PTSD), and opiate addiction. In recent years, a handful of psychedelic products have been launched and developments were announced or initiated by companies worldwide, including established pharmaceuticals like Johnson & Johnson. Numinus Wellness Inc. (TSX-V: NUMI) (OTC: LKYSD), Mind Medicine (MindMed) Inc. (OTC: MMEDF) (NEO: MMED), Champignon Brands Inc. (OTC: SHRMF) (CSE: SHRM), Seelos Therapeutics, Inc. (NASDAQ: SEEL), Johnson & Johnson (NYSE: JNJ)

Psychedelics are a class of psychoactive substances that produce changes in perception, mood and cognitive processes. Examples of some of the recent announcements related to psychedelics used in a medical context include the FDA's approval of the first ketamine based psychedelic medicine from Johnston & Johnston to treat depression, called Spravato, back in 2019. Additionally, also in 2019, Denver became the first state to decriminalize magic mushrooms (Psilocybin), taking a similar path to the legalization of marijuana. Then, in November 2019, the FDA awarded the second Breakthrough Therapy designation to non-profit Usona Institute, which is also studying the effects of psilocybin as an anti-depressant. In the United States alone, the psychedelic drugs market is projected to reach a value of USD 6,859.95 Million by 2027 from USD 2,077.90 Million in 2019 while growing at a CAGR of 16.3% during the forecast period of 2020 to 2027, according to Data Bridge Market Research.

Numinus Wellness Inc. (TSX-V: NUMI) (OTC: LKYSD) announced today breaking news regarding, "the appointment of Dr. Gabor Maté, MD, CM, as a Member of the Numinus Clinical Advisory Council. Through over 30 years' work in family practice, palliative care and addiction medicine, Dr. Maté has pioneered therapies and innovative, trauma-based approaches to mental health. His advocacy for mental health research and awareness have earned him international recognition from the healthcare community.

"We at Numinus are extremely honoured and excited to have someone with Gabor's pedigree and on-the-ground experience," says Numinus CEO Payton Nyquvest. "Gabor offers exceptional insight on the mental health landscape and its future, which greatly complements our goals and mission at Numinus."

As a Member of the Clinical Advisory Council, Dr. Maté will be a vital resource in helping Numinus develop treatments and drive policy changes within the healthcare industry. Additionally, Dr. Maté will also use his network to enhance Numinus's collaboration with other leading researchers and groups working in mental illness, addiction and trauma treatment.

"Gabor is a well-respected clinician with a wealth of knowledge on the links between trauma and mental health, as well as ways to promote healing," says Dr. Evan Wood, Chief Medical Officer of Numinus. "He has been on the forefront of innovative mental health strategies for many years and I look forward to collaborating with him to advance the Numinus model."

Dr. Maté is internationally recognised for his expertise in addiction, trauma, childhood development, and the link between stress and illness. Beyond his work as a medical practitioner, he is a sought-after speaker and bestselling author with reprints in over 25 languages. His book on addiction received the Hubert Evans Prize for literary non-fiction. For his groundbreaking medical work and writing, he has been awarded the Order of Canada, Canada's highest civilian distinction, and the Civic Merit Award from his hometown of Vancouver, B.C.

As part of his effort to broaden public awareness of mental illness and contribute to the local community, Dr. Maté spent over a decade working in Vancouver's Downtown Eastside caring for patients facing severe addiction and mental health challenges. Dr. Maté continues to push boundaries and identify new pathways for healing and advancement in mental health."

Mind Medicine (MindMed) Inc. (OTC: MMEDF) (NEO: MMED) announced earlier this month that, on May 8th, 2020, it had entered into a clinical trial agreement with Maastricht University to undertake a Phase 2a clinical trial for lysergic acid diethylamide ("LSD") in adult patients with Attention Deficit Hyperactivity Disorder ("ADHD"). MindMed previously established a microdosing division to develop a portfolio of clinical trials studying the use of sub-perceptual amounts of psychedelic substances for medical purposes. As part of the agreement, Maastricht University will provide facilities and personnel for the Phase 2a Proof of Concept Clinical Trial for MindMed's multicentre, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of low dose LSD as treatment for ADHD in adults.

Champignon Brands Inc. (OTC: SHRMF) (CSE: SHRM) reported earlier this month that it is to sponsor TheraPsil, a BC-based non-profit coalition of healthcare professionals, policy-makers and community leaders (the "TheraPsil Coalition") seeking legal access to psilocybin for British Columbians with a palliative diagnosis and psychological distress. Operating at highest standards of clinical competence and ethical integrity, the TheraPsil coalition is starting in 2020 with seeking legal access to psilocybin for British Columbians with a palliative diagnosis and psychological distress. "We're really happy to have this support to get the ball rolling on this project to help palliative Canadians. We are dedicated to giving those at end-of-life the treatment options they deserve - and that includes psilocybin. We believe that as a non-profit, and with the right support, we can get these patients their right to treatment with psilocybin in a timely manner," Dr. Bruce Tobin, founder of TheraPsil.

Seelos Therapeutics, Inc. (NASDAQ: SEEL) a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, announced earlier this year additional interim data from its Phase I studies of Intranasal Racemic Ketamine (SLS-002). Seelos also announced that it completed its Type C meeting with the U.S. Food and Drug Administration (FDA) as scheduled to discuss the protocol design for a study of SLS-002 for Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD). Interim data disclosed includes the hemodynamic (vital signs) side effect profile to address the known and expected side effects of ketamine, which are increases in blood pressure and heart rate.

Johnson & Johnson (NYSE: JNJ) announced earlier this year the submission of a Type II Variation Application to the European Medicines Agency (EMA) for SPRAVATO®▼ (esketamine) nasal spray. The application seeks to expand the use of esketamine nasal spray, beyond its current indication, as an acute short-term treatment, co-administered with oral antidepressant therapy, for the rapid reduction of depressive symptoms in adults with a moderate-tosevere depressive episode of major depressive disorder (MDD) who have current suicidal ideation with intent. "Janssen is committed to reducing the devastating burden caused by serious mental health disorders," said Husseini K. Manji, M.D., Global Head, Neuroscience Therapeutic Area, Janssen Research & Development, LLC. "There is a need to provide treatments that can rapidly reduce depressive symptoms of individuals living with MDD who are in need of urgent relief. We therefore look forward to working with the EMA to provide a new targeted treatment that could potentially deliver meaningful results for these patients."

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