Palm Beach, FL –November 4, 2021 – FinancialNewsMedia.com News Commentary – The pace of society’s change in attitude to the use of psychedelics has been amazing. It has gone from a “Born To Be Wild”, hippie counter-culture illegal drug… to a rapidly growing mainline, positive tool prescribed by physicians and therapists worldwide on a daily basis. In the last year or so, the Covid-19 pandemic has restricted movement, confining people in their homes, causing severe stress and trauma, and affecting mental health. As a result, in many countries, people are increasingly facing medical conditions like depression and anxiety. The psychedelic drugs market, with major potential for treatment of mental illnesses, is likely to see more demand and hence likely to attract major investments in the near future. A report from ResearchAndMarkets said that the Global Psychedelic Drugs Market was valued at USD 3.8 billion in the year 2020 and is expected to reach $4.07 Billion in 2021 and should reach $7.58 in revenues by 2026. The report said: “The Psychedelic Drugs market is growing rapidly due to the increasing prevalence of depression and other mental disorders worldwide. The need for handling environmental stress and enhanced and better quality of lifestyle is acting as a driver for the Psychedelic Drugs market. The treatment for psychedelic drugs dependency is expected to boost psychedelic market growth. Active companies in the markets this week include: Mind Cure Health Inc. (OTCQX: MCURF) (CSE: MCUR), Cybin Inc. (NYSE: CYBN) (NEO: CYBN), Numinus Wellness Inc. (OTCPK: LKYSF) (TSXV: NUMI), Atai Life Sciences N.V. (NASDAQ: ATAI), COMPASS Pathways plc (NASDAQ: CMPS).
ResearchAndMarkets continued with: “In addition, rising research and development activities in psychedelic therapeutics categories across the world have supported industrial development significantly. Companies are aggressively investing in R&D activities to develop novel psychedelic treatment molecules with minimal side effects associated with these products. This has further resulted in a strong platform for the further growth of the psychedelic drug industry during the forecast period 2026). The North America region dominates the psychedelic drugs market. In North America, growing awareness of mental health disorders such as depression and stress is expected to boost the psychedelic drug market growth. Social elements such as economic stress, the partition of family-oriented supporting structures, exacerbating environmental conditions are further estimated to accelerate market growth during forecast period (2026).”
Mind Cure Health Inc. (CSE: MCUR.CNQ) (OTCQX: MCURF) BREAKING NEWS: MINDCURE Provides Update on Studies and Clinical Trials – Mind Cure Health Inc, a leader in advanced proprietary technology and research for psychedelics, is pleased to provide an operational progress update on the strategic initiatives of its operating segments – MINDCURE Research and MINDCURE Technology.
Synthetic Ibogaine Production Update – In March 2021, MINDCURE announced the initiation of chemical synthesis routes for the production of fully synthetic ibogaine. In July 2021, the Company applied for patents on two routes to full chemical synthesis and initiated the production of Good Laboratory Practice (“GLP”) ibogaine leading to the production of Good Manufacturing Practice (“GMP”) ibogaine in order to scale and manufacture a global supply of fully synthetic ibogaine. MINDCURE is currently on schedule and expects to have GLP supply available for research partners beginning in Q2 of 2022.
Pre-Clinical Update – MINDCURE confirms that it is preparing to ship ibogaine drug material to its pre-clinical research partner. The material will initially be used for broad cardiac and neurologic screens, with the potential to conduct in-depth behavioral studies. This program has been identified as MSYNTH-001, and the Company expects results from the first studies during the first quarter of 2022.
In addition to advancing the scale of its synthetic ibogaine program, MINDCURE continues to explore options for drug pipeline expansion. Two candidate selection programs are currently underway, known internally as MC-106 and MC-808. The Company will provide further information on these programs in the second quarter of 2022.
Clinical Trial Update – MINDCURE has completed its draft research protocol for the use of MDMA and psychotherapy to treat female sexual hypoactive desire disorder, known as The Desire Project. The Company expects a pre-IND meeting with the FDA to be scheduled in the first quarter of 2022 and for its Phase 2 trial to begin by the third quarter of 2022. Further, site initiation and initial screening are planned for March 2022, with recruitment and enrollment to follow.
“We are proud to report that MINDCURE’s core research programs are progressing rapidly, showcasing our disciplined commitment to advancing MINDCURE’s drug research and commercial production programs. Concurrently, we maintain a focus on identifying opportunities to expand our drug development pipeline,” said Kelsey Ramsden, President & Chief Executive Officer of MINDCURE.
Digital Platform iSTRYM Update – The Company released the minimum viable product (“MVP”) of its digital therapeutics (DTx) technology, iSTRYM, into partner clinics across North America in August. MINDCURE is pleased to announce that it has exceeded its previously announced target and timeline of 10 clinics by the end of 2021. The Company has already partnered with 20 ketamine clinics in nine states in the US and three provinces in Canada and plans to expand to the broader mental health market in 2022.
In addition, MINDCURE will begin full commercial deployment to all partner clinics in early 2022, with expansion plans to the UK and Europe by the fourth quarter of 2022.
In addition to its recently announced letter of intent with Awakn Life Sciences Corp. to distribute their Ketamine for Alcohol Use Disorder (“AUD”) protocol in North America via iSTRYM, MINDCURE will expand its selection of existing ketamine protocols with an additional MINDCURE developed protocol in the first quarter of 2022. The Company is continuing on its path toward becoming a leader in the distribution of best-in-class therapy protocols for both partners and providers.
Observational Study Update – MINDCURE is pleased to announce that its Integration Protocol Research Study is complete. As previously announced in March 2021, unconditional ethics approval from Veritas IRB was received for the study. The data has been amassed and findings incorporated into the MVP of iSTRYM. As a next step, the Company’s research partners will submit findings for publication. Understanding integration protocols and practices is an important part of providing best-in-class care specific to psychedelic medicines in practice. 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. (NYSE American: CYBN) (NEO: 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.
Numinus Wellness Inc. (OTCPK: LKYSF) (TSXV: NUMI), a leader in psychedelics-focused mental healthcare, recently 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 RXTM developed 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.
atai Life Sciences (NASDAQ: ATAI) recently announced that it has observed encouraging interim data from the first 8-patient cohort of its Phase 2a trial, demonstrating potential pro-cognitive effects of its compound RL-007, a cholinergic, glutamatergic, and GABA type B receptor modulator, for Cognitive Impairment Associated with Schizophrenia (CIAS).
These early data have led atai to commit additional financial resources, enabling an accelerated clinical development timeline for RL-007, even ahead of completion of the ongoing Phase 2a trial. The interim Phase 2a readout reported promising assessments for the 8-patient cohort from two quantitative biomarkers, qEEG (quantitative electroencephalogram) and ERP (evoked-response potential) and indicated changes that are consistent with improved cognition. CIAS is a major unmet need for those living with schizophrenia, with no effective treatments currently available. Full results of the current Phase 2a trial are expected by the end of 2021.
COMPASS Pathways plc (NASDAQ: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, recently announced it will be conducting a phase II clinical trial to assess the safety and tolerability of COMP360 psilocybin therapy in post-traumatic stress disorder (PTSD). The study expands COMPASS’s research pipeline in psilocybin therapy with COMP360, the company’s proprietary formulation of synthetic psilocybin which COMPASS is currently developing for treatment-resistant depression.
The phase II, multicentre, fixed-dose open label COMP201 study will enrol 20 participants to evaluate the safety and tolerability of COMP360 psilocybin therapy in people who suffer with PTSD resulting from trauma experienced as adults. The study will begin at The Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London. Participants will receive a single 25mg dose of COMP360 psilocybin, given in conjunction with specialist psychological support, in line with the COMP360 psilocybin therapy protocol, and will be followed up for 12 weeks. The primary endpoint of the study is to assess the safety of COMP360 psilocybin therapy. Secondary endpoints will measure efficacy in improving PTSD symptoms, functionality, and quality of life.
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