Developments with Ketamine Psychotherapy Are Driving A Medical Revolution For Treating Mental Health Issues

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Oct 28, 2021, 08:30 ET

PALM BEACH, Fla., Oct. 28, 2021 /PRNewswire/ -- FinancialNewsMedia.com News Commentary - Psychedelic drugs such as psilocybin, LSD and MDMA have tremendous medical and commercial future potential… and for ketamine, the "future" is now. Drug developers and clinic specialists offer numerous ketamine-related commercial opportunities. Psychedelic stock investors are used to regularly reading about "the renaissance in psychedelic drugs". Currently, illegal drugs like psilocybin, LSD and MDMA are seeing an explosion in new medical research. Part of this renaissance is that it is filling a present need, the COVID global health crisis where 2 billion treatable mental health disorders are leading to 8 million preventable deaths per year. Also, psychedelic drugs possess powerful medicinal properties, and combined with psychotherapy, provide clear potential to actually cure these mental health disorders. Ironically, however, the psychedelic drug that has benefitted most to date from this renaissance is the only one that was already broadly legal: ketamine. A report from Psychedelic Stock Watch said that ketamine was originally popularized as an anesthetic. However, it has been used off-label for many years to treat pain conditions. More recently, it has also been used off-label in the treatment of mental health disorders, most notably depression, PTSD and addiction. Ketamine also produces a "dissociative experience" (or "trip") like other psychedelics, and it is also used illicitly. But ketamine avoided the drug Prohibition deep-freeze that banished other psychedelic drugs from even valid research purposes for many years. Active companies in the markets this week include: Mind Cure Health Inc. (OTCQX: MCURF) (CSE: MCUR), Cybin Inc. (NYSE: CYBN) (NEO: CYBN), Field Trip Health Ltd. (NASDAQ: FTRP) (TSX: FTRP), Numinus Wellness Inc. (OTCPK: LKYSF) (TSXV: NUMI), Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED).

Psychedelic Stock Watch continued: "Medical professionals and industry entrepreneurs have begun building a new industry on the medical/commercial potential of psychedelics like: psilocybin, LSD, MDMA, DMT and ibogaine. A significant percentage of these people have gravitated to ketamine R&D and ketamine-based mental health therapies – because they are already fully legal. Ketamine-based therapy has already demonstrated greater efficacy in treating depression than conventional therapies. Its usage in treating addiction and PTSD is also spreading quickly. Concurrent with this are a multitude of new R&D programs featuring ketamine-based therapies. Like psilocybin, LSD and MDMA, a large-and-growing number of formal clinical trials are underway or about to commence involving ketamine. However, ketamine's friendlier legal status means that ketamine-based R&D is generally more expedited."

Mind Cure Health Inc. (CSE: MCUR.CNQ) (OTCQX: MCURF) BREAKING NEWS: MINDCURE Signs LOI with Awakn Life Sciences to Distribute Ketamine Protocol for Alcohol Use Disorder into Clinics Across United States and Canada through iSTRYM, MINDCURE's Digital Therapeutics Platform - Mind Cure Health Inc, a leader in advanced proprietary technology and research for psychedelics, is pleased to announce the signing of a non-binding letter of intent ("LOI") with Awakn Life Sciences (NEO: AWKN)(OTCQB: AWKNF) ("Awakn"), a biotechnology company with clinical operations researching, developing, and delivering psychedelic medicine to better treat Addiction.

The Company will enter into an agreement with Awakn to be a distributor of its ketamine-assisted psychotherapy for Alcohol Use Disorder (AUD) protocol in the US and Canada. Awakn's protocol will be distributed through iSTRYM, MINDCURE's digital therapeutics platform.

MINDCURE released the minimum viable product (MVP) version of iSTRYM into partner clinics across North America in August and will begin full commercial deployment to all partner clinics in Q1 of 2022. The company forecasts 75 partner clinics in Canada and the US deploying iSTRYM upon commercialization. Further deployment anticipates 150 clinics across Canada, the US, the UK, and Europe by Q4 2022.

iSTRYM provides a digital distribution network of science-based protocols developed by MINDCURE's clinical partners, companies, academic institutions, and other healthcare providers directly to therapists. The Company is already partnering with ketamine-assisted psychotherapy clinics in nine states in the US and two provinces in Canada with plans to expand to the broader mental health market in 2022. The distribution component of iSTRYM unlocks another revenue line for MINDCURE, in addition to clinic and patient level revenues from the platform.

"Awakn's goal is to fully integrate evidence-backed psychedelic-assisted psychotherapy into mainstream healthcare to better treat addiction. We're currently building the UK and Europe's leading chain of medical psychedelic clinics with a focus on treating addiction and other mental health conditions," said Anthony Tennyson, CEO of Awakn Life Sciences. "We are extremely pleased that we now also have a partnership with MINDCURE to distribute our ketamine-assisted psychotherapy for Alcohol Use Disorder protocol through their iSTRYM platform in the US and Canada."

Awakn acquired the licensing rights from the University of Exeter for a ketamine-assisted psychotherapy treatment for AUD, which has been validated in a completed Phase II a/b trial. Awakn's license to use and deliver the 'Ketamine in the Reduction of Alcoholic Relapse' (KARE) psychotherapy treatment will be deployed in each of Awakn's clinics in the UK and Europe and will be led by a consultant psychiatrist. Awakn's Team includes world leading scientific, research and clinical experts in the treatment addiction, led by Professor David Nutt, who serves as Awakn's Chief Research Officer and Chair of both the Scientific Advisory Boards (Preclinical and Clinical). The KARE protocol will be distributed by MINDCURE in its digital therapeutic platform across its growing network of clinical partners in the US and Canada.

"Improving mental health is a global challenge and we're building iSTRYM to be an innovative global solution," said Kelsey Ramsden, President & CEO, MINDCURE. "This is our first of many overseas partnerships with industry leaders who are developing scientifically rigorous psychedelics protocols and drugs whereby our technology provides a natural distribution partner to support both patients and therapists." 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:

Cybin Inc. (NEO:CYBN) (NYSE American: CYBN), a biotechnology company focused on progressing psychedelic therapeutics, recently announced that the U.S. Food and Drug Administration ("FDA") has authorized an Investigational New Drug ("IND") application to proceed with the Company's sponsored feasibility study using Kernel's Flow technology to measure ketamine's psychedelic effect on cerebral cortex hemodynamics.

"The word psychedelic means 'mind-manifesting,' but what has been missing is useful 'mind-imaging'—the ability to dynamically trace the neural correlates of human conscious experience. Conventional neuroimaging just isn't dynamic enough to study the psychedelic experience in the brain as it happens. This study of ketamine's psychedelic effects while wearing headgear equipped with sensors to record brain activity could open up new frontiers of understanding," said Dr. Alex Belser, Cybin's Chief Clinical Officer.

Field Trip Health Ltd. (NASDAQ: FTRP) (TSX: FTRP), a global leader in the development and delivery of psychedelic therapies, recently announced the opening of their Seattle clinic, their sixth in the United States, along with the recent opening of a location in Fredericton, NB, and the imminent opening of a location in Vancouver, BC. As the largest provider of psychedelic-assisted therapies globally, Field Trip continues to distinguish itself as a leader in the emerging psychedelic industry with continued expansion and growing demand.

Mental health continues to be a national health crisis as rates of anxiety, depression and PTSD keep climbing. Since opening its first location in March 2020, Field Trip's ketamine-assisted therapy (KAP) protocols have generated rapid and meaningful improvements for many Field Trip clients as measured by depression and anxiety scales. Based on the data collected to date, Field Trip clients have reported that their depression symptoms improved significantly from "severe" to "mild" on average (with the Mean PHQ9 score of respondents decreasing from 17 to 6), and among respondents such benefits were sustained for 120 days or longer from commencement of treatment. These results suggest that the benefits of Field Trip's KAP program may compare favorably to ketamine infusions. Each Field Trip Health center is designed to provide an oasis-like setting with elements of nature to give Field Trip clients a space for healing, growth and transformation through psychedelic therapies. The entire experience is supported by Field Trip's digital technology and tools that guide people through the process from before treatment is approved until after their treatment program is complete, and beyond.

Numinus Wellness Inc. (OTCPK: LKYSF) (TSXV: NUMI), a leader in psychedelics-focused mental healthcare, recently announced that it has finalized the study design and protocol for a Phase 1 clinical trial on a naturally derived Psilocybin extract, previously announced on April 26, 2021. This major milestone advances Numinus' investigation of its first proprietary psychedelic product, which was developed using a patent-pending technology submitted to the US Patent and Trade Office.

Numinus Bioscience has successfully developed a natural extract, PSYBINA^™from Psilocybe species using IP technology related to the production of extracts and downstream derivatives and formulations from Psychoactive Species Cultured Mycelium. The Phase I clinical trial, "A Healthy Adult Investigation Observing Endpoint Measures of Safety and Relative Bioavailability of Psilocybin in comparison to a Psilocybe extract: a fasting, blinded, crossover study" (HOPE), will ascertain the safety and bioavailability of the subsequent formulation PSYBINA RX^TMdeveloped to stably deliver Psilocybin and other synergistic compounds. The trial design compares the innovative formulation, designed to be more bioavailable, with synthetic Psilocybin as a baseline comparator and exploratory brain scans will visualize the potential differences in neuroactivity.

Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED), a leading biotech company developing psychedelic-inspired therapies, recently announced an expansion of its pipeline with the launch of a program to develop R(-)-MDMA for the treatment of social anxiety and functioning in diagnoses that include Autism Spectrum Disorder (ASD). This program represents a significant expansion and diversification of MindMed's pipeline and furthers the Company's mission to bring innovative products to benefit patients and address unmet medical needs.

Social anxiety and impairments in social functioning are hallmarks of ASD, which occurs in approximately 2% of individuals in the US. At present, there are no approved therapies for the core symptoms of ASD and there remains a significant unmet need for novel therapies to support people with ASD. The economic cost of ASD in the US is predicted to reach $461 billion by 2025, highlighting the need and opportunity for novel interventions. Beyond ASD, approximately 12% of the US general population experience Social Anxiety Disorder at some point in their lives, according to the National Institute of Mental Health.

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