Why Mainstream Mental-Health Care is Embracing Psilocybin - Alternative Active Substances

Financialnewsmedia.com News Commentary

PALM BEACH, Fla., March 31, 2021 /PRNewswire/ -- Psychedelic healing may sound like a fad from the Woodstock era, but it's a field of study that's gaining traction in the medical community as an effective treatment option for a growing number of mental health conditions. While the study of psychedelics as medicine, all across the globe, is inching toward the mainstream, it still remains somewhat controversial. Psychedelics have struggled to shake a "counterculture" perception that was born in the 1960s, a view that had stymied scientific study of them for more than 50 years… But that perception is slowly changing. Mounting research suggests that controlled treatment with psychedelics like psilocybin mushrooms, LSD, and MDMA -- better known as ecstasy -- may be effective options for people suffering from PTSD, anxiety disorders, and depression. The U.S. Food & Drug Administration recently granted "breakthrough therapy" status to study the medical benefits of psychedelics. And two years ago this month, the FDA approved a psychedelic drug -- esketamine -- to treat depression. A recent article on WIRED (UK) projected that Psychedelic medicine will begin to cross over into the mental health mainstream in 2021.  "In both Europe and the US, medicines regulators have eased restrictions on using MDMA to treat post-traumatic disorder (PTSD), and on psilocybin – the active substance in magic mushrooms – to treat depression. 2021 will bring new clinical trials, as support for the use of psychedelics in medicine continues to gain momentum…"  Active companies in the markets this week include: Mind Cure Health Inc. (OTCQB: MCURF) (CSE: MCUR), Cybin Inc. (OTCQB: CLXPF) (NEO: CYBN), Mind Medicine (MindMed) Inc. (OTCQB: MMEDF) (NEO: MMED), Numinus Wellness Inc. (OTCPK: LKYSF) (TSXV: NUMI), COMPASS Pathways plc (NASDAQ: CMPS).

The article continued:  "Clinical research into psychedelics has boomed in the past five years and investors are taking note. The US Multidisciplinary Association for Psychedelic Studies (MAPS), which researches the topic, reached a $30 million (£23 million) fundraising target in 2020, on top of $80m of historical funds. This money will enable the completion of a phase-3 trial in the use of MDMA to treat PTSD, which will be necessary to achieve Food and Drug Administration approval. In the UK, London-based mental-health care company COMPASS Pathways has raised more than $115m to fund its efforts and bring to market a psilocybin treatment for depression. In August, the company filed an application to issue an IPO on the Nasdaq."

Mind Cure Health Inc. (CSE: MCUR.CNQ) (OTCQB: MCURF) BREAKING NEWS:  MINDCURE Files Provisional Patent Application For iSTRYM, its Proprietary AI Digital Therapeutics (DTx) SaaS Platform, Designed To Enhance Effectiveness Of Psychedelic-Assisted Therapies For Practitioners And Patients - Mind Cure Health Inc,  an industry leader in advanced proprietary technology for psychedelic therapy, that also identifies, develops, and commercializes various proprietary  products that enhance mental health and wellness, ease suffering, and increase productivity, is pleased to announce that it has submitted a provisional patent application with the United States Patent and Trademark Office to cover iSTRYM, the company's proprietary digital therapeutics (DTx) tool.

iSTRYM is an investigating technology that focuses on patient feedback and data-driven insights into the efficacy of treatments in order to assist in the application of more effective and more efficient diagnosis techniques and treatments. It's a technology that is targeted for both therapists and patients.

MINDCURE is investing significant resources into its near term revenue strategy, developing the proprietary iSTRYM technology and digital therapeutics (DTx), targeting the value that these tools offer to the emerging markets of psychedelics and psychedelic-assisted therapy. DTx are evidence-based therapies delivered via software to complement existing treatments. What is unique about DTx compared to other health care technologies is that they require approval from regulatory bodies, unlocking the potential for insurer paid revenue streams. One approved by regulatory bodies, our technology and the fact based developed & more efficient therapies it gives birth to, will be adopted and utilized across a majority of practitioner therapists and patients, and become the service tool of choice. Its designed to be the model platform that becomes the industry backbone to identify and aggregate the best and most efficient protocols optimized by AI. It quantifies a number of therapies to create a universe of personalized and precision medical therapies identified in trials and individually recommended for each patient's unique situation and needs.

iSTRYM will arm therapists with better tools and patient insights rooted in data while providing quantified care at scale to individuals who go through the therapeutic process. 

"When people think of MINDCURE, I want them to see us as the leader in technology and specifically digital therapeutics for the psychedelics industry," said Kelsey Ramsden, President and CEO, MINDCURE. "We intend to build iSTRYM into the world's largest data repository of psychedelic experiences, backed by science and built on trust. This is why we were so thrilled to recently receive ethics approval from Veritas for our integration protocol research study, and why we view this provisional patent application as the next milestone for iSTRYM." She continued: "Digital therapeutics (DTx) were gaining popularity as tools to help slash the $3 trillion annual spending (in the US alone) on chronic disease, and the pandemic has vaulted digital therapies into that spotlight. We are at the right place in time and  we believe that could bode well for our shareholders."  CONTINUED… To read this and more news for Mind Cure Health, please visit  https://www.financialnewsmedia.com/news-mcur/   

Other recent developments in the markets include:

Mind Medicine (NEO: MMED) (OTCQB: MMEDF), a leading psychedelic medicine biotech company, has recently announced its annual 2020 financial results for the year ended December 31, 2020.  2020 Financial Highlights (in USD): Total assets as of December 31, 2020were $85.6 million, including $80.1 millioni n cash; Net Cash Used in Operating Activities (Total Cash Burn) of $24.2 million for the year ended December 31, 2020; and Net and comprehensive loss of $35.1 million for the year ended December 31, 2020.

Current Cash Balance as of March 30, 2021 maintains a current cash balance of $161 million USD ($203 million CAD) to advance its portfolio and build out its technology division.  MindMed is a psychedelic medicine biotech company seeking to discover, develop and deploy psychedelic inspired medicines and therapies to address addiction and mental illness. The Company is assembling a drug development pipeline of innovative treatments based on psychedelic substances including Psilocybin, LSD, MDMA, DMT and an Ibogaine derivative, 18-MC.

Numinus Wellness Inc. (OTCPK: LKYSF) (TSXV: NUMI),  a company creating an ecosystem of solutions centered on the research, development, and delivery of safe, evidence-based, accessible psychedelic-assisted psychotherapies, has recently announced it will undertake a compassionate access clinical trial of psilocybin-assisted psychotherapy for substance use disorders. This study will enable the company to implement, test, and refine optimal protocols for the use of psilocybin-assisted psychotherapy for participants with a range of substance use disorders and will be conducted in collaboration with Syreon Corportion, a global contract research organization with expertise in conducting clinical trials across a broad range of chronic and complex diseases. The study will involve an initial 30 participants who will take part in a motivational enhancement psychedelic psychotherapy intervention with psilocybin.

According to Health Canada's Special Access Programme, compassionate access single-arm open-label clinical trials can be incorporated into drug development planning to "meet the needs of patients who are not eligible for enrollment in other pivotal trials" and is one of Health Canada's preferred means for patients to access drugs that are not yet available on the market.

COMPASS Pathways plc (NASDAQ: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, recently announced that it has been granted two new patents by the US Patent and Trademark Office (USPTO). These patents cover oral formulations of COMPASS's synthetic psilocybin in the treatment of major depressive disorder (MDD), which includes treatment-resistant depression (TRD).

US Patent No 10,954,259 was granted on 23 March 2021, with claims to COMPASS's high-purity crystalline psilocybin (including the form used in its synthetic formulation, COMP360), pharmaceutical formulations containing crystalline psilocybin and methods of treating MDD with the crystalline psilocybin.  US Patent No 10,947,257 was granted on 16 March 2021, with claims to oral dosage forms of crystalline psilocybin and methods of treating MDD with the oral dosage forms.

Cybin Inc. (OTCQB: CLXPF) (NEO: CYBN) recently announced the availability of a broadcast titled, "Science Drives Surging Interest in Psychedelic Therapeutics."  Psilocybins are a hallucinogenic substance found in certain types of mushroom, dubbed magic mushrooms, and used for centuries by indigenous cultures for religious, spiritual and health-related purposes. As is often the case, the modern world is learning from the ancient as mounting evidence points to these prolific fungi as a source for long-sought-for help in mental health and neurological disorders.

The Company is intent on becoming the leader in this exciting breakthrough for mental well-being. The company is at the forefront of the revolution in mental health therapeutics and is developing a new class of psychedelic medicines and treatment protocols. Driving its commitment to excellence is the company's impressive leadership team of experienced professionals with a combined 80-plus years in the pharmaceutical industry.

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