North America Continues Leading The Way In Psychedelic Wellness

PALM BEACH, Fla., Oct. 26, 2021 /PRNewswire/ -- FinancialNewsMedia.com News Commentary - The global psychedelic drugs market remains at an early stage in its life cycle, with most companies currently developing their go-to-market strategy. The market players of psychedelics are involved in the clinical trials of several psychedelic drugs to address mental health, which continues to present significant unmet need. For the behavioral health industry, psychedelics present an opportunity to potentially bolster providers' treatment toolbox and help patients for whom current psychiatric medications have failed. While it's unclear exactly what the future of psychedelics in the U.S. behavioral health industry will look like, Canadians are looking at a clearer picture. When it comes to psychedelic wellness, Canada is leading the way, according to Behavioral Health Business. They said: Regulations were recently relaxed there to make it easier for alternative medicine companies to develop psychedelic behavioral health treatments. Those newfound flexibilities are similar to right-to-try laws in the US, which allow terminally ill patients to use experimental therapies that have passed Phase I in the U.S. Food and Drug Administration's approval process. The difference, however, is that only one state in the US — along with several municipalities — has authorized exemptions for psilocybin; meanwhile, all 13 Canadian provinces and territories currently have exemptions for the psychedelic substance often used as a source for alternative behavioral health treatments."   Active Companies active today in markets include:  Cybin Inc. (NYSE: CYBN) (NEO: CYBN), COMPASS Pathways plc (NASDAQ: CMPS), Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), Eli Lilly and Company (NYSE: LLY), Johnson & Johnson (NYSE: JNJ).

Under the care of a clinician, patients using psilocybin for behavioral health treatment typically receive the psychedelic drug to treat conditions like stress, anxiety and depression, especially for patients who have not had success using other treatments or are facing terminal illnesses.  As with the US, possession of psilocybin mushrooms in Canada is illegal. However, last August, Health Canada — the country's regulatory health body — approved the use of psilocybin to treat four terminally ill patients for anxiety, stress and depression. Several months later, in December, Health Canada also approved exemptions to a group of doctors and therapists to use psilocybin for research purposes, allowing them to study its effects on patients in hopes of developing therapies for future use.  As a result, British Columbia — which is also home to a number of Canadian cannabis companies — has become a hotbed for psychedelic wellness startups.

Cybin Inc. (NYSE AMERICAN: CYBN) (NEO: CYBN) BREAKING NEWS:  Cybin Announces FDA Investigational New Drug Authorization of Cybin's Sponsored Feasibility Study using Kernel Flow Technology - Cybin Inc. ("Cybin" or the "Company"), a biotechnology company focused on progressing psychedelic therapeutics, today 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. 

Leveraging Kernel's quantitative neuroimaging technology ("Kernel Flow") may lead to new frontiers in psychedelic therapeutics by enabling the acquisition of longitudinal brain activity before, during and after a psychedelic experience, providing quantification of what was previously subjective patient reporting.

"Quantitatively measuring the brain within the context of a psychedelic experience is a promising frontier," said Bryan Johnson, founder and Chief Executive Officer of Kernel. "With Kernel Flow, Cybin's researchers can start putting numbers and quantification to subjective states of mind, including altered ones."

Kernel Flow uses pulsed light instead of continuous wave light to increase measured brain information. In contrast with electroencephalography ("EEG") electrodes that usually require gel on the head or functional magnetic resonance imaging ("fMRI") studies that require a participant to lie in a scanner, Kernel Flow is easily wearable. The entire system is the size and look of a bicycle helmet and could, in the future, be more broadly used for neuroscientific or physiological studies of brain activity during psychedelic use.

As part of Cybin's sponsorship of the feasibility study, the Company will retain an exclusive interest in any innovations that are discovered or developed through its independent analysis of the study findings. Kernel will hold the same rights relating to its Kernel technology.  CONTINUED… Read the full Press Release for Cybin at:  https://www.cybin.com/news 

In other active company biotech news in the markets this week: 

COMPASS Pathways plc (NASDAQ: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, recently welcomed the topline data shared from an open-label study of psilocybin therapy for depression in cancer patients. Within one week of a single administration of COMP360 psilocybin therapy, 50% of participants achieved remission in depression symptoms, which was sustained for the eight week follow-up period.

This investigator-initiated feasibility study was conducted by Maryland Oncology Hematology at the Aquilino Cancer Center in Rockville, Maryland, USA. It was an open-label study involving 30 patients with cancer diagnosis and major depressive disorder (MDD), all of whom completed the study. Half of the participants had previously been treated for their current episode of depression with antidepressants and all were receiving active treatment for cancer; 19 participants had no previous experience with psychedelic substances. Patients were given a 25mg dose of COMP360 psilocybin in conjunction with psychological support from specially trained therapists, following the COMP360 psilocybin therapy protocol.

Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), a leading biotech company developing psychedelic-inspired therapies, recently announced that Dr. Matthias Liechti presented data from several ongoing studies at the INSIGHT Conference in Berlin, Germany. These investigator-initiated studies are being conducted as part of MindMed's ongoing collaboration with the UHB Liechti Lab.

"While both LSD and psilocybin have a long history in psychiatric research, psilocybin is being studied in a majority of ongoing clinical trials of psychedelics," said Dr. Liechti. "It is important for us to understand the acute effect characteristics of different psychedelics, and to understand how these substances interact with other treatments like antidepressants. We look forward to fully analyzing the exciting data produced by these studies and publishing our findings later this year."

Eli Lilly and Company (NYSE: LLY) recently announced the board of directors of Eli Lilly and Company (NYSE: LLY) has declared a dividend for the fourth quarter of 2021 of $0.85 per share on outstanding common stock.

The dividend is payable on December 10, 2021 to shareholders of record at the close of business on November 15, 2021.Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. 

Johnson & Johnson (NYSE: JNJ) The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) previously announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for esketamine nasal spray. Janssen is seeking FDA approval of esketamine for treatment-resistant depression in adults.

Esketamine is an investigational, rapidly acting antidepressant that works differently than currently available therapies for major depressive disorder. Through glutamate receptor modulation, esketamine is thought to help restore connections between brain cells in people with treatment-resistant depression. 

"Of the nearly 300 million people who suffer from major depressive disorder worldwide, about one-third do not respond to currently available treatments.^3,4 This represents a major unmet public health need," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. "We are committed to working with the FDA to bring this new treatment option to U.S. patients with treatment-resistant depression and to the medical community."

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