NEW YORK, Nov. 1, 2021 /PRNewswire/ -- There isn't a cigarette smoker in the world who doesn't know smoking is bad for them. The problems are that nicotine is one of the most highly addictive substances in the world, and for the nearly 70% of 34.1 million Americans who want to kick the habit, there aren't many smoking-cessation options that have proven safe and effective. Hope may be looming on the horizon, however, with new research building on prior studies that suggest psilocybin is not only a potential solution but also a more effective one. Leading a charge on this front is Mydecine Innovations Group(NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (Profile), a biopharmaceutical firm formed in 2020 for the purpose of developing innovative therapeutics to treat PTSD, depression, anxiety, addiction and other mental health disorders. Mydecine is part of a renaissance for psychedelic medicine research that is showing real promise in addressing areas of unmet medical need. Those contributing to the resurgence includes peers such as COMPASS Pathways Plc(NASDAQ: CMPS), ATAI Life Sciences N.V.(NASDAQ: ATAI), Cybin Inc.(NYSE American: CYBN) and Field Trip Health Ltd.(NASDAQ: FTRP).

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Chantix Recall Leaves $1 Billion Up for Grabs

According to the Centers for Disease Control and Prevention, cigarette smoking is responsible for one of every five deaths in the United States annually, while the World Health Organization estimates tobacco-use costs at more than $1.4 trillion in health expenditures and lost productivity each year. It's not that people don't want to quit smoking; many do. CDC data shows that 55% of smokers have tried to quit, but only about 7.5% succeed.

The desperation for anti-smoking products is exemplified by the drug varenicline (brand name Chantix), which became a blockbuster with 2019 sales of $1.1 billion despite serious psychiatric side effects. Ultimately, Chantix was recalled in 2021, not for the psychiatric adverse events but for "theoretical potential increased cancer risk."

Perhaps new treatments involving psilocybin, the active psychedelic ingredient in "magic" mushrooms, will fill that $1 billion void. A small study by Johns Hopkins University published in "Journal of Psychopharmacology" compared smokers trying to quit using cognitive behavioral therapy (CBT) plus varying doses of psilocybin to abstinence rates typically observed in smokers using other medications or CBT alone. The results showed 67% of the participants remained nicotine free at a 12-month follow-up, a substantial increase over success rates for other methods (typically 10% to 35%).

The study concluded that the "results suggest that in the context of a structured treatment program, psilocybin holds considerable promise in promoting long-term smoking abstinence." Johns Hopkins is conducting a larger efficacy study with compelling data to date, and this month received the first National Institute of Health (NIH) grant in more than 50 years to directly investigate the therapeutic effect of psilocybin for tobacco addiction.

Mydecine Innovations Group(NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA)is an integral part of this landmark NIH-funded research led by Johns Hopkins, a three-year, multisite smoking cessation study being conducted in collaboration with University of Alabama at Birmingham and New York University. Mydecine will be supplying its lead drug candidate, MYCO-001 (99% pure psilocybin), for use in the clinical trials. The supply agreement, in the words of Mydecine CEO Josh Bartch, "not only offers a significant opportunity to further advance our drug development through safer and more viable results but demonstrates Mydecine's leadership position in the emerging psychedelic-assisted psychotherapy industry."

The joint work on the new clinical trial builds upon the budding relationship between Mydecine and Johns Hopkins, considered the top university for psychedelic research globally. Denver-based Mydecine was already working with the team of Dr. Matthew Johnson, a psychedelics authority and professor of psychiatry and behavioral sciences at Johns Hopkins, on smoking-cessation projects using psychedelics. In August that partnership parlayed into a five-year master collaboration research agreement to look at several novel therapies and compounds for the treatment of a multitude of mental health and addiction disorders. Johnson is the lead on the upcoming NIH-funded trials and will be lending his expertise to other upcoming clinical studies by Mydecine.

Catalyst: Clinical Trials for MYCO-001

Clinical trials are milestones and catalysts for biopharma companies, and Mydecine is staring at three of them in 2022 for MYCO-001. First is the NIH-funded, multicenter study. Second is a company-sponsored seamless phase 2/3 clinical trial also evaluating the administration of MYCO-001 with a structured smoking-cessation treatment program in nicotine-dependent individuals. The trials will run concurrently, and Johnson will be serving as principal investigator in both trials.

Encouraged by FDA commissioner Dr. Scott Gottlieb in 2017 to speed up drug development, a "seamless" clinical trial utilizes an adaptive design to combine two or more traditional phases of the FDA process, which can save not only considerable time but also significant money. Mydecine anticipates its investigational new drug (IND) meeting with the FDA this quarter and to commence another study in January 2022. The study protocol is expected to involve treating participants weekly in one-on-one sessions for five weeks prior to quitting smoking. Primary endpoints will be smoking abstinence at three, six and twelve months.

ResearchandMarkets.com estimates the global smoking cessation market to be growing 16.9% annually to reach $63.99 billion by 2026. The rapidly expanding market and room for new products to capture significant share likely underscore Roth Capital analyst Elemer Piros initiating coverage on Mydecine with a Buy rating and C$3 price target.

PTSD in Veterans, EMS and Front-Line Workers

The master collaboration agreement with Johns Hopkins demonstrates Mydecine's commitment to advancing psychedelic medicine by exploring multiple molecules and medicines for a variety of indications. One of the first targets is post-traumatic stress disorder (PTSD) in veterans, emergency medical service (EMS) and front-line workers.

Currently there are no medications that have been developed to treat PTSD, and those that are prescribed to treat the symptoms can be addictive and often have unpleasant side effects. Mydecine is expecting an IND meeting with the FDA this quarter and plans to start a Phase 2a study involving veterans with PTSD during January 2022 spanning three U.S. sites, two Canadian sites and one in the Netherlands.

A Holistic Approach: MYCO-003 and Mindleap

While those trials progress, Mydecine has three other flagship drug candidates in the pipeline, including MYCO-003, a psilocybin formulation that combines a serotonin agonist with a serotonin-releasing agent. Fact is, a "bad" trip is a possibility when ingesting psilocybin, which requires supportive care from the attending physician. The risk can be exacerbated by patients with high anxiety or PTSD, which Mydecine believes it can mitigate without the need for extensive supportive care through its novel formulation. The company has recently reported positive preclinical data on MYCO-003 and filed a patent application as an anxiety-reducing product.

Many people receiving psychedelic therapy refer to the experience as spiritual, religious, mystical and the like, which gets to the breakthrough opportunity of the treatment by addressing the root cause in the brain rather than putting a Band-Aid on the surface.

Healing and meaningful change are processes that are part-and-parcel to psychedelic regimens. Mindleap Health, a unit of Mydecine, supports this journey as an inner wellness application and community that provides tools for self-discovery. Mindleap offers a comprehensive platform that introduces users to psychedelic integration, dream analysis and deepening awareness with top experts as a part of a holistic, real healing approach.

Investors Cheer as Evidence Mounts

Decades ago, a growing body of evidence highlighted the potent therapeutic effect of psychedelic compounds for hard-to-treat diseases. Some 51 years after President Richard Nixon signed the Controlled Substance Act that stymied R&D work with psychedelics, those same diseases remain pervasive and resistant to traditional therapies. While more clinical studies will lend further indubitable data, that work is gaining steam.

COMPASS Pathways Plc(NASDAQ: CMPS) is a mental health-care company dedicated to accelerating patient access to evidence-based innovation in mental health. The company is pioneering the development of a new model of psilocybin therapy, in which its proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a breakthrough therapy by the FDA for treatment-resistant depression, and COMPASS is currently conducting a phase IIb clinical trial of psilocybin therapy for TRD in 22 sites across Europe and North America.

ATAI Life Sciences N.V.(NASDAQ: ATAI)is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. Founded in 2018, atai is dedicated to acquiring, incubating and efficiently developing innovative therapeutics with a focus on psychedelic therapies to treat depression, anxiety, addiction, and other mental health disorders. Most recently, its DemeRx IB business announced that the first subjects have been dosed in a Phase 1/2a clinical trial of ibogaine HCl (DMX-1002) for opioid use disorder.

Cybin Inc.(NYSE American: CYBN)is focused on progressing psychedelic therapeutics by utilizing proprietary drug-discovery platforms, innovative drug-delivery systems, novel formulation approaches and treatment regimens for psychiatric disorders. In its bid to create a world-class portfolio of psychedelic molecules that can become commercially viable drug candidates for internal development or partnering, Cybin this month completed 74 in-vitro and in-vivo evaluations of its expanding portfolio of psychedelic compounds. To date, more than 50 novel compounds have been evaluated through collaborations with experienced contract research organizations.

Field Trip Health Ltd.(NASDAQ: FTRP)is the global leader in the development and delivery of psychedelic therapies. The company's Field Trip Discovery division is focused on the development of next-generation psychedelic molecules and is conducting advanced research on plant-based psychedelics; its Field Trip Health division is opening centers for psychedelic therapies across North America and Europe.

Thanks to strong investor appetite and hundreds of millions of dollars in funding, psychedelic research is accelerating and clinics making the treatment readily available are cropping up all over the world. The days of viewing psychedelics as merely amusements of counterculture are fading and, for the first time in a long time, it feels like the world is closing in on a new psychedelic-based therapy to fill gaps where traditional drug makers have failed.

For more information about Mydecine Innovations, please visit Mydecine Innovations Group.

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