Psychedelics Industry Gearing Up For an Even Bigger 2021

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December 21, 2020

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NEW YORK, Dec. 21, 2020 /PRNewswire/ -- Investments continued flowing into the psychedelic medicine sector this year and will likely continue in 2021 as mental illness cases rise across the globe. The World Health Organization (WHO) estimates that 700 million cases of mental and neurological disorders are reported annually, accounting for 13% of global disease burden. Of course, these are only reported cases, so the number is likely much higher and will likely rise further due to the ongoing health crisis. Luckily, growing awareness around mental illness has led to a slew of research and development for effective novel treatments to help combat the growing mental health crisis. Psychedelic medicine for mental illness is one area that has gained the spotlight after Johnson & Johnson's (NYSE: JNJ) severe depression drug was handed approval. Now, a number of psychedelic-focused companies like Mydecine Innovations Group Inc. (CSE: MYCO) (MYCOF), COMPASS Pathways Plc (NASDAQ: CMPS), Tonix Pharmaceuticals (NASDAQ: TNXP), and Numinus Wellness Inc. (NEO: NUMI) (TSXV: NUMI) (OTCPK: LKYSF) are joining the fight against mental illness with a variety of promising, psychedelic-based treatments.

Biopharma and life sciences company Mydecine Innovations Group is focused on developing and commercializing innovative solutions to treat mental health problems and enhance well being. Since the beginning of 2020, the company has hit several significant milestones to help progress its robust pipeline of psychedelic derived therapeutics, novel compounds, therapies, and controlled drug delivery systems.

Mydecine Innovations Edges Towards FDA Filing

Sentiments toward psychedelic-derived medicines have evolved significantly in the last couple of years, especially following the US Food and Drug Administration's (FDA) approval of  Johnson & Johnson's (NYSE:JNJ) Ketamine-like drug treatment for severe depression in March 2019. The FDA approved Spravato as a fast-acting treatment for patients with hard-to-treat depression and it became the first of several psychoactive substances moving through the US regulatory process. The administration has since granted Breakthrough Therapy Designation to two psychedelic treatments, paving the way for others to follow suit.

Mydecine Innovations Group just announced that it has partnered with ProPharma Group to proceed with the FDA filing and approval of its drug development platform and various stage clinical trials. ProPharma is the leading provider of regulatory and compliance services to the pharmaceutical, biotech, and medical device industries with "a strong track record of working with life sciences and biopharma companies to ensure full compliance with all FDA regulations, including all necessary steps for eventual global federal approvals."

Earlier this month, Mydecine Innovations reached another exciting milestone by completing its first commercial harvest of 20 kilograms of psilocybin mushrooms at its research and cultivation facility in Jamaica. The company is now preparing to export the harvest to its Canadian cGMP Facility, which holds a Health Canada schedule 1 Dealer's License, allowing for legal import.

Once Mydecine's facility receives the psilocybin mushrooms, they will be extracted, refined, and turned into a cGMP product that can be used for controlled therapeutic purposes. The final product will be available for purchase by licensed institutions and companies conducting clinical research of these compounds to treat various health conditions like anxiety, addiction, depression, and PTSD. Portions of the harvest will also be kept for Mydecine's proprietary genetic, pharmacology, and clinical research, including psilocybin-assisted psychotherapy to treat PTSD in veterans and frontline workers.

Another company looking to combat PTSD is Tonix Pharmaceuticals (NASDAQ:TNXP), although it isn't using psychedelic compounds in its formulation like Mydecine. The company began studying TNX-601 (tianeptine oxalate) for the treatment of PTSD in September 2019. However, Tonix hit a speedbump in its Phase III RECOVERY study in February 2020 and decided to stop enrollment in the study following inadequate results. However, Tonix has since gone back to the drawing board and recently outlined a new statistical method to analyze future PTSD drug studies.

Growing Number of Psychedelic Companies Entering the Public Markets

The psychedelic drugs market is forecast to grow at a CAGR of 16.3% to reach $6.85 billion by 2027, fueled by the growing acceptance of psychedelic-derived meds to treat mental health coupled with the rising prevalence of mental disorders like depression and anxiety. Loosening legislation is also favoring the psychedelics market, leading to a growing number of psychedelic-focused pharma companies entering the public markets and bringing in investment dollars.

Integrated mental health company Numinus Wellness Inc. (NEO:NUMI) (TSXV:NUMI) (OTC:LKYSF) joined the TSX Venture Exchange in September 2020 after getting the green light from Health Canada to produce and extract psilocybin from mushrooms and closing an oversubscribed $4.6 million offering. In December, the company announced a $10 million bought deal offering, which was increased to $15 million two days later, and completed the first legal extraction of psilocybe mushrooms.

COMPASS Pathways Plc (NASDAQ:CMPS) also joined the public markets in September after closing an astounding $146.6 million initial public offering (IPO). The listing came nearly two years after the company was handed FDA Breakthrough Therapy designation for its psilocybin therapy for treatment-resistant depression. On November 12, Compass announced its Q3 results, highlighting the steady progress in its Phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression and the opening of a new trial site in Berlin, Germany. The company also joined an international collaboration to accelerate drug discovery in mental health care.

Mydecine Innovations Group has also inked a partnership agreement this year with Applied Pharmaceutical Innovation to advance its research and development efforts for mental health care solutions. This partnership helps to put Mydecine ahead of the curve in this innovative market.