USA News Group – Before the global health crisis began at the beginning of 2020, 1 in 5 adults were receiving mental health treatment. As society emerges from the last two and a half years of disruptions, it’s anticipated that the mental health crisis will inevitably be much, much worse. A new report from Reportlinker.com on the Global Central Nervous System (CNS) Therapeutics Industry projects that pain drugs, neorology and psychiatry will collectively hit $132.1 billion by 2024. But unlike times past, the biotech sector is seemingly thinking outside of the box, with the market seeing billions of dollars in investments into what were previously seen as taboo forms of treatment, including psychedelics and functional mushrooms, including the work of newly IPO’d Doseology Sciences Inc. (CSE:MOOD), GH Research PLC (NASDAQ:GHRS), Mind Medicine (MindMed) Inc. (NASDAQ:MNMD) (NEO:MMED), Cybin Inc. (NYSE:CYBN) (NEO:CYBN) and even Johnson & Johnson (NYSE:JNJ).

Significant research has shown positive effects from certain herbs or mushrooms known as adaptogens with respect to stress reduction, resistance to mental fatigue, and improved attention capacity. This has given impetus to the rapidly growing functional mushroom market which is projected to grow at a CAGR of 6.1% to US$572 billion globally by 2028.

Targeting this market, Doseology Sciences Inc. (CSE:MOOD) announced a soft launch of seven new adaptogenic mushroom products earlier this year in the United States, while also officially launching its medicinal mushroom product line (consisting of five products) in Canada in late February 2022.

Doseology’s products address different segments of the market, including mood and depression, attention and focus, sleep and recovery, and anxiety. They do so through proprietary formulations pairing adaptogenic botanicals with vitamins for increased efficacy that make extensive use of natural mushroom fruiting bodies.

The product lines combine adaptogens such as ginger, turmeric, yerba mate, and several mushroom species, with proven functional mushrooms such as lion's mane, reishi, shiitake, maitake, royal sun, turkey tail, and others. Blending these formulations delivers enhanced health and wellness benefits over single-ingredient products.

"This launch is the culmination of extensive product development, market testing, and months of planning," said Doseology’s new CEO Maryam Marissen. "We're proud to finally deliver the benefits of nootropic medicinal mushrooms to our home market. We believe our strong brand, proprietary formulations, GMP standardization, and easy-to-use products will make our medicinal mushrooms the go-to brand in Canada."

Back in April 2021 when it was still a private company, GH Research PLC (NASDAQ:GHRS) announced the closing of $125 million in financing, an impressive number for a private preclinical firm. By late June 2021, GH would IPO on the NASDAQ, having gained attention for turning 5-MeO-DMT into medicine for treatment-resistant depression.

By December, the company had already announced the successful outcome of the Phase II part of its Phase 1/2 Clinical Trial of its candidate GH001 in the same affliction. The primary endpoint of the Phase 2 part of the trial was met with 7 of 8 patients (87.5%) in remission (Montgomery–Åsberg Depression Rating Scale (MADRS) ≤10) at day 7 after dosing (p<0.0001). According to FDA Guidance for Industry, a 7-day endpoint is an appropriate primary efficacy endpoint for rapid-acting antidepressants.

Fellow developers of psychedelic-inspired therapies, Mind Medicine (MindMed) Inc. (NASDAQ:MNMD) (NEO:MMED), also recently announced the publication of a study, this time comparing the acute effects of lysergic acid diethylamide (more commonly known as “LSD”) and psilocybin in healthy subjects at the University Hospital Basel—the birthplace of hallucinogenic science.

The data from the study demonstrates that the key differences between LSD and psilocybin are dose-dependent rather than substance-dependent. Thanks to these findings, therapists will be able to potentially assist with dose finding, trial design and inform future studies evaluating the therapeutic utility of psychedelics. MindMed retains executive rights to data from this investigator initiated study conducted at the University Hospital Basel.

"LSD and psilocybin have recently become promising candidates for the treatment of various psychiatric and neurologic disorders, and thus a deeper understanding of their differential subjective effects in humans is needed,” said Miri Halperin Wernli, Ph.D., Executive President of MindMed. “This study brings us one step closer to maximizing the therapeutic potential of these molecules, by providing valuable dose finding context and enabling more direct comparisons when interpreting clinical results."

Cybin Inc. (NYSE:CYBN) (NEO:CYBN) recently announced the availability of a broadcast titled “Psychedelic Therapies Offer Hope for Mental Health”, highlighting that mental disorders affect more than 900 million people globally with direct and indirect economic costs of a staggering $2.5 trillion.

The psychedelic-based therapeutics developer Cybin will soon be initiating a PH 2 study evaluating its deuterated psilocybin analog CYB003 for the treatment of major depressive disorder (MDD) depression. Soon after, the company also will have a pilot study for its deuterated DMT program, CYB004, while the FDA has greenlit a PH 2 trial that will utilize Cybin’s EMBARK^TM psychedelic facilitator training program and a first-of-its-kind PH 1 neuroimaging study that Cybin will co-sponsor.

Cybin has also announced a partnership with The Chopra Foundation, founded by well-known speaker and author Dr. Deepak Chopra, to increase education and awareness of the potential use of psychedelics in supporting well-being and mental health.

Though technically not a “psychedelic”, the use of ketamine in the FDA-approved drug Spravato from Johnson & Johnson (NYSE:JNJ) subsidiary Janssen. Back in 2019, the esketamine HCI nasal spray gained trial wins for treating high-risk depression. Since then, gained approval for treating those at risk of suicide, as well as expanded use in Europe through authorization from the European Commission (EC).

Today, research is being done at Yale to study ketamine’s effect on individuals with epilepsy. Assistant professor of psychiatry at the Yale School of Medicine, Sarah Fineberg, along with an attending psychiatrist at the Connecticut Mental Health Center, will be the principal investigator of a study investigating the impact of ketamine, a short-acting anesthetic, on individuals suffering from epilepsy.

Studies are also being conducted involving Spravato that are suggesting ketamine and psychological therapy may help people with severe alcohol use disorder. Researchers published the results of a phase III clinical trial of the drug back in January in the American Journal of Psychiatry.

Article Source: https://usanewsgroup.com/2021/11/15/the-multi-billion-dollar-mental-health-idea-thats-finally-in-bloom/

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