November 1, 2021 -- InvestorsHub NewsWire -- via NetworkNewsWire
Editorial Coverage: 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) (NEO:
CYBN) and Field Trip Health
Ltd. (NASDAQ:
FTRP).
- Cigarette smoking is responsible for one of every five deaths
in the U.S. annually, while sapping more than $1.4 billion from the
global economy.
- Mydecine is emerging as a leader in psychedelics for smoking
cessation, partnering with Johns Hopkins University on several
drug-development projects.
- MYCOF will be supplying its MYCO-001 (99% pure psilocybin) to
an NIH-funded clinical trial led by Johns Hopkins.
- Mydecine intends to commence two separate clinical trials of
MYCO-001 for smoking cessation and post-traumatic stress disorder
in veterans.
Click here to view the custom infographic of
the Mydecine Innovations
Group editorial.
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) (NEO:
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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