Neural plasticity is instrumental in brain health, and the importance of neuroplasticity can't be overstated. Indeed, the inability of the nervous system to change its activity in response to stimuli often produces stress-induced neuroplasticity, which plays a critical role in almost all mental disorders. The problem is conventional drugs have done little to correct damage in this response, resulting in mental health disorders that now affect nearly one in every eight people on the planet. Amazingly, research with psychedelic therapeutics has shown great promise, inspiring hope in treating a broad range of mental health disorders. With the urgent need for new, more effective treatments to treat a wide spectrum of disorders, Cybin Inc. (NEO: CYBN)(NYSE American: CYBN)(Profile) is pioneering groundbreaking research and striking important partnerships to unleash the power of these psychedelic-based compounds. Cybin has a differentiated method of progressing psychedelics into therapeutics than others in the sector, such as COMPASS Pathways Plc (NASDAQ: CMPS), Mind Medicine Inc. (NASDAQ:MNMD) (NEO: MMED), ATAI Life Sciences N.V. (NASDAQ: ATAI) and GH Research PLC (NASDAQ: GHRS), which are also intent on offering effective solutions. Cybin is looking to lead the psychedelic renaissance that could for the first time deliver treatments to address the root of mental maladies rather than just mask the symptoms with conventional drugs. Mental disorders affect more than 900 million people globally with direct and indirect economic costs of a staggering $2.5 trillion.
-- Cybin is on the brink of initiating a PH 2 study evaluating its deuterated psilocybin analog CYB003 for the treatment of MDD with a pilot study for its deuterated DMT program CYB004 following shortly behind.
-- The FDA has green-lighted 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 cosponsored by Cybin.
-- Cybin has formed a new partnership with The Chopra Foundation and attracted investments from investment titan BlackRock and others.
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Power of Psychedelics
There are several existing and experimental drugs that act upon neural plasticity but do so slowly and with limited protracted effect on key circuits. Psychedelic compounds have seen a spike in interest due to their apparent ability to overcome these challenges, rapidly producing structural and functional changes that result in a durable positive effect on function and, subsequently, behavior.
There's strong belief that different classes of psychedelics, such as ketamine, psilocybin, DMT and MDMA, can be developed for a wide range of unmet medical needs. These needs may include hard-to-treat disease and disorders such as anxiety, depression, addiction and post-traumatic stress, among others. In aggregate, mental health maladies affect more than 900 million people globally with direct and indirect economic costs of a staggering $2.5 trillion. Today, therapeutics protocols are dominated by antipsychotic and antidepressant drugs, often in conjunction with some form of counseling therapy.
Cybin Inc. (NEO: CYBN)(NYSE American: CYBN) has established a leadership position in the psychedelic-based therapeutics space based on its proprietary scientific approach and drug-development ecosystem, which delivers the healing properties of classical psychedelics while reducing variable side effects. Cybin leverages existing clinical data combined with medicinal chemistry and drug-delivery technologies to improve the patient experience by overcoming the limitations of current treatments for mental illness.
This innovative biopharmaceutical company has one of the most robust pipelines in the industry. The company's 140-plus completed preclinical studies is supporting the development of 50 novel psychedelic-based compounds across three different patent families. Little surprise that Cybin recently received a new U.S. patent protecting CYB004, the company's lead investigational proprietary deuterated DMT compound for treating anxiety disorders. Given the company's scientific rigor, many more patents are likely to follow.
Cybin continues to differentiate itself from its peers -- becoming the first psychedelic company listed on the NYSE American, cosponsoring the first-of-its-kind neuroimaging study with psychedelics, and developing proprietary compounds that have the potential to improve the well-known variability and side effects of classical psychedelics for better patient outcomes. This mindful, patient-centric approach has caught the attention of key thought leaders, resulting in more than 50 professional partnerships with top scientists and contract research organizations. The company's most recent milestone partnership includes a new collaboration with The Chopra Foundation designed to help support education and awareness for its groundbreaking research and development aimed at harnessing the potential for psychedelic-based therapies in mental health.
EMBARKing Down the FDA Path
An investigator-initiated trial being conducted by Dr. Anthony Back, professor of medicine (oncology) at the University of Washington School of Medicine, is utilizing Cybin's six-domain psychedelic facilitator training program, EMBARK. The Phase 2 trial is evaluating psilocybin for the treatment of mental distress in frontline healthcare workers suffering from depression, anxiety and burnout.
The EMBARK Psychedelic Facilitator Training Program is a new training curriculum based on a groundbreaking psychotherapy model that integrates leading clinical approaches to promote supportive healing with psychedelic medicine. EMBARK was coauthored by Dr. Alex Belser, Cybin's chief clinical officer, and provides all the foundational training needed to provide skillful and ethical care to participants receiving these new psychedelic-based treatments.
The company is also close to initiating a Phase 1/2a trial for CYB003, its lead investigational psychedelic-based compound, for the potential treatment of major depressive disorder (MDD) and alcohol use disorder (AUD). CYB003 is derived from psilocybin, which is part of a family of molecules that act as neurotransmitters, such as serotonin. Encouraging preclinical data demonstrated that the CYB003 therapeutic profile was less variable than classical psilocybin and may offer safer dosing options and more predictable patient outcomes.Cybin is set to initiate the Phase 1/2a trial in mid-2022.
Cybin's second development program that is set to enter the clinic is CYB004, its deuterated dimethyltryptamine (DMT) molecule. DMT has been shown to exert its psychedelic effects via activation of the 5HT2A receptor. In its natural form, DMT is rapidly metabolized in the body, fairly unstable and not orally bioavailable. The deuterated version of DMT, however, has the potential to overcome these limitations and provide increased oral and pulmonary bioavailability, faster onset with lower doses and less patient variability. CYB004 has the potential to effectively treat anxiety disorders. A pilot study is expected to begin in the third quarter of 2022.
In addition, earlier this year an Institutional Review Board approved a Cybin-sponsored feasibility study evaluating a quantitative neuroimaging technology from neurotech pioneer Kernel to measure ketamine's psychedelic effect on cerebral cortex hemodynamics. The first-of-its-kind study utilizing Kernel Flow will measure longitudinal brain activity before, during and after the psychedelic experience, and provide quantitative data that may lead to a better understanding of the effectiveness of psychedelic treatments. The study received FDA Investigational New Drug (IND) authorization in October 2021 and is expected to begin enrollment soon.
Attracting Institutions & Partners
As awareness of psychoplastogens as a potential disruptor to the biopharma industry in healing mental disorders becomes crystallized, ever more leading influencers and institutions are increasing their exposure to the sector. This includes the ARK Genomic Revolution ETF, which initiated a position in ATAI Life Sciences this month. In addition, investment titan BlackRock Advisors, the world's largest money manager with $9.5 trillion in assets under management, secured a position in Cybin in the fourth quarter of 2021. BlackRock joins healthcare fund manager OrbiMed, Citadel Advisors, Horizons ETFs Management (Canada) Inc. and other institutions holding shares of CYBN.
Most recently, Cybin received additional validation recently via a new partnership with The Chopra Foundation, a not-for-profit organization dedicated to improving health and well-being founded by Dr. Deepak Chopra. The foundation is working closely with Cybin to support education and awareness about its pioneering research and development in harnessing the potential of psychedelic-based therapies in mental health.
"Through our NeverAlone movement, we aim to combine forces with the best and brightest across businesses, policymakers, mental health professionals, and others -- all with the goal of building awareness, advancing scientific research, and creating a global community to ensure widespread access to well-being resources," said Dr. Chopra. "[Cybin's] differentiated method is thoughtful and ethical, and Cybin is one of the only companies that may truly address the needs of patients and providers."
The Lineage to Succeed
Cybin is achieving success thanks to scientific rigor and a talented leadership team that has expanded staff from just 5 to 55 employees across four countries (Canada, the United States, the United Kingdom and and Ireland). In November, the U.S. Drug Enforcement Agency awarded Cybin a Schedule I manufacturing license for its state-of-the-art lab facility in Boston. The DEA license is a federal requirement for any researchers who intend to study, produce, analyze or otherwise work with Schedule I controlled substances, as psychedelics are currently categorized.
The Cybin team has a lengthy list of achievements, including 37 sell-side exits across the biotech sector and other verticals plus hands-on involvement in the development of widely used drugs such as Allegra, Sabril, Anzemet, Vaniqa, Zyprexa, Cymbalta, Neupro and Vimpat. Most importantly, Cybin team members have provided guidance and oversight for more than 60 IND programs under FDA protocols and have 300 combined peer-reviewed publications to their credit covering research in addiction and psychedelics, among many others.
The Most Exciting Time in Mental Wellness
There are myriad reasons to be extremely encouraged about the therapeutic power of psychedelics and the future of mental wellness. Groundbreaking psychedelic-based R&D is the most productive and meaningful research ever conducted into these potential game-changing therapeutics, offering hope for debilitating and vast unmet need.
COMPASS Pathways Plc (NASDAQ: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, recently announced results from its exploratory study of COMP360 psilocybin therapy in conjunction with SSRI use. "The results of this study challenge the widely held belief that the use of SSRI medication together with psilocybin could interfere with psilocybin's therapeutic effect," said COMPASS chief medical officer Guy Goodwin. "Our findings provide a strong signal that COMP360 psilocybin therapy could be an adjunctive treatment to SSRI antidepressants as well as a monotherapy."
Mind Medicine Inc. (NASDAQ: MNMD) (NEO: MMED), a clinical-stage biopharmaceutical company developing psychedelic-inspired therapies for the treatment of brain-based disorders, has received FDA clearance for its Investigational New Drug (IND) application. This allows the company to move forward with its Phase 2b dose-optimization trial of its proprietary drug candicate MM-120 for the treatment of generalized anxiety disorder (GAD). "FDA clearance of our Phase 2b clinical trial represents a major milestone, for MindMed and for the industry as a whole," said MindMe CEO and director Robert Barrow.
ATAI Life Sciences N.V. (NASDAQ: ATAI), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, has launched Invyxis, a new, wholly owned platform company committed to developing new chemical entities and further pioneer next-generation mental health treatments. Invyxis will bring proven medicinal chemistry tools and comprehensive biological screening approaches to atai's growing enterprise of drug discovery and design. The company noted that the launch of Invyxis is a further step up in its growth and commitment to innovation in the treatment of mental health disorders.
GH Research PLC (NASDAQ: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, released results from its Phase 2 part of a Phase 1/2 clinical trial of GH001, the company's proprietary inhalable 5-MeO-DMT product candidate. The trial evaluated patients with treatment-resistant depression. The company noted its primary and secondary endpoints were met, with seven of eight patients in remission at day 7 after dosing and GH001 being well tolerated with no serious adverse events reported.
The psychedelic therapeutics space has lumbered along over the past year, arguably creating opportunities for value players. While retail has been cautious, big money has not, with investment in psychedelic therapeutics companies topping $2 billion in 2021. That type of institutional commitment bolsters additional investment and spurs research that may well lead to new therapeutic breakthroughs to help the millions of people so desperately in need.
For more information about Cybin Inc., please visit Cybin Inc.
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