November 03, 2021 -- InvestorsHub NewsWire -- NetworkNewsWire
Editorial Coverage: Global destigmatization, changing
regulations and an upswing in research are speaking loudly to the
opportunity for psychedelics to provide tangible improvements in
medicine to address some of the most resistant, devastating and
expensive conditions known to man. For decades, drugmakers have
spent billions of dollars searching for therapies that can safely
help people quit smoking and alleviate anxiety, as well as treat
those with notoriously difficult diseases such as autism.
Unfortunately, the conventional efforts have been to little avail.
Fortunately, meaningful progress is being made with psychedelics
across multiple fronts, such as the work of 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, addiction and other mental
health disorders. Mydecine is part of a renaissance for psychedelic
medicine research that has captured investors’ attention, albeit
through individual companies such as Mind
Medicine (MindMed) Inc. (NASDAQ:
MNMD) and Seelos Therapeutics Inc. (NASDAQ:
SEEL), or through exchange traded funds that provide
exposure to a swath of companies, such as AdvisorShares Trust (NYSE ARCA:
PSIL) and Horizons Psychedelic Stock Index ETF (NEO:
PSYK).
- Cigarette smoking is responsible for 20% of all American deaths
every year, creating a $1.4 trillion drain globally in associated
costs.
- Mydecine, Johns Hopkins, University of Alabama and NYU are
participating in the first clinical research to receive funding
from the NIH in more than 50 years.
- MYCOF will be supplying its MYCO-001 to the NIH-funded clinical
trial as part of a smoking cessation treatment.
- The company expects to conduct two other clinical trials of
MYCO-001 for smoking cessation and PTSD in veterans during
2020
Click here to view the custom infographic of
the Mydecine Innovations
Group editorial.
An Opportunity Case Study: Cigarette
Smoking
Most people understand the deadly risks associated with
cigarette smoking and that nicotine is highly addictive,
as addictive as
heroin by many accounts. The market is flooded with
options (gums, herbals, patches, etc.) for those wanting to quit
cigarettes, but these have proven mostly ineffective, leaving the
nearly 70% of 34.1 million
Americans who want to break their addiction with little in
the way of safe and effective smoking-cessation options. Data lends
color to the addressable market. Smoking is responsible for 20% of
all U.S. deaths and associated healthcare costs and lost
productivity of $1.4
trillion annually. According to the CDC, about 55% of
smokers have tried to quit, but about 7 out of every 100
succeed.
Now, consider a small study by Johns Hopkins
University comparing smokers trying to quit using
cognitive behavioral therapy (“CBT”) plus varying doses of
psilocybin (the active psychedelic ingredient in “magic” mushrooms)
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%). Johns Hopkins is following-up with larger
efficacy study funded in part by 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 in collaboration with
University of Alabama at Birmingham and New York University.
Mydecine is supplying its lead drug candidate, MYCO-001 (99% pure
psilocybin), for use in the three-year, multisite smoking cessation
clinical trial. The supply agreement has multiple benefits for
Mydecine, cementing their position as a leader in the emerging
psychedelic-assisted psychotherapy industry while allowing them to
simultaneously advance MYCO-001 clinical development in
collaboration with the biggest names in the business.
The new supply agreement builds upon an existing relationship
between Colorado-based Mydecine and Johns Hopkins, considered the
top university for psychedelic research globally. Among other
things, Mydecine was working with Dr. Matthew Johnson, lead in the
NIH clinical studies, professor of psychiatry and behavior sciences
at Johns Hopkins and a world-renowned expert on psychedelics, on
smoking cessation research and potential upcoming clinical work by
Mydecine. Elsewhere, Mydecine in August penned a five-year master
collaboration research agreement with Johns Hopkins to
evaluate new treatments and compounds for a variety of addiction
disorders and mental health conditions.
On Tap: Phase 2/3 Clinical Trial of
MYCO-001
Mydecine is aligning for three clinical trials of MYCO-001 in
2022, any (or all) of which could serve as a catalyst for the
company. The NIH-funded multi-center study with Johns Hopkins, NYU
and UofA-Birmingham is one. Another 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. Dr. Johnson is serving as the PI
(principal investigator) in both clinical studies.
A “seamless” clinical trial has become a buzz word in recent
years thanks to FDA
commissioner Dr. Scott Gottlieb supporting the format in
2017 as a means to accelerate drug development. The concept is an
adaptive design combining at least two of the traditional phases of
drug development, with modifications made if necessary following
interim data readouts. The design can shave substantial time and
costs compared to the conventional FDA pathway of separate phases.
Mydecine is expecting an investigational new drug (“IND”) meeting
with the FDA by the end of the year and to launch the trial in
January 2022. The protocol for the trial is expected to involve
weekly individual sessions for five weeks before the patient tries
to quit smoking with endpoints including smoking abstinence at
three, six and twelve months.
The company is hoping to penetrate a global smoking cessation
market estimated by ResearchandMarkets.com growing at a 16.9%
compound annual growth rate to $63.99 billion by 2026. This type of
growth and market opportunity is likely contributing rationale to
Roth Capital analyst Elemer Piros initiating
coverage on Mydecine with a Buy rating and C$3 price
target.
PTSD in the Underappreciated
While smoking cessation is a vital part of the pipeline,
Mydecine is committed to exploring the diverse opportunities of
psychedelics to offer relief where other drugs have failed or come
with unpleasant side effects. An initial target outside of smoking
is post-traumatic stress disorder (“PTSD”) in veterans, emergency
medical service (“EMS”) and front-line workers, a group that as a
whole goes grossly underappreciated for the day-to-day grind of the
job.
There are no medications approved by the FDA specifically for
PTSD, only those that are used to attempt to soften the symptoms;
the medications are often highly addictive or have side effects of
their own. Once again, Mydecine is looking to hold an IND meeting
with the FDA this quarter for the purpose to initiate a Phase 2a
clinical trial in the first quarter of 2022 evaluating a
psychedelic regimen for veterans with PTSD, which it intends to
host at three U.S. sites, two Canadian sites and one site in the
Netherlands.
Providing a Complete Journey of Healing
As those three trials move forward, Mydecine is addressing other
aspects of therapy, including a mindful approach to a holistic
journey to recover. Frequently, patients undergoing psychedelic
therapy refer to the process as an “experience” following
adjectives such as “spiritual” or “religious” or even “out of body”
where breakthroughs of the mind are achieved to set forth a durable
course of healing by addressing the root issue, rather than just
dulling symptoms. As part of this journey, Mydecine offers Mindleap
Health, an inner wellness application and community that provides
tools for self-discovery. The comprehensive platform introduces
users to psychedelic integration, dream analysis and deepening
awareness with top experts as a part of a whole healing
approach.
Elsewhere, Mydecine has three other flagship drug candidates in
its portfolio, including MYCO-003, a psilocybin formulation that
combines a serotonin agonist with a serotonin-releasing agent. This
formulation is meant to overcome obstacles related to a “bad trip”
that can sometimes accompany ingesting psilocybin. This experience,
which could be exacerbated in highly anxious patients, requires
intervention by the attending physician. 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.
Don’t Call It a Comeback
Believe it or not, there was a growing body of evidence
supporting the therapeutic benefits of psychedelics ongoing in the
mid-20th century. However, the emphasis on a counter-culture and
President Richard Nixon signing into law the Controlled Substance
Act in 1970 put the kibosh on psychedelic clinical research. A half
century later, the stigma is fading, the data is becoming
indisputable and investments are growing to bring new treatments to
market.
Mind
Medicine (MindMed) Inc. (NASDAQ: MNMD) is one of
the most recognizable names in the market. The
company is assembling a drug-development pipeline of
innovative treatments based on psychedelic substances including
psilocybin, LSD, MDMA, DMT and an ibogaine derivative, 18-MC. Most
recently, MindMed expanded its pipeline with the launch of a
program to develop R(-)-MDMA for the treatment of social anxiety
and functioning in diagnoses that include Autism Spectrum Disorder
(“ASD”).
Seelos Therapeutics Inc. (NASDAQ:
SEEL) is a clinical-stage biopharmaceutical
company focused on the development and advancement of novel
therapeutics to address unmet medical needs for the benefit of
patients with central nervous system (“CNS”) disorders and other
rare diseases. The company’s
portfolio includes several late-stage clinical assets
targeting indications including acute suicidal ideation and
behavior (“ASIB”) in major depressive disorder (“MDD”) or PTSD,
amyotrophic lateral sclerosis (“ALS”), Sanfilippo syndrome,
Parkinson’s Disease, and other psychiatric and movement disorders
plus orphan diseases.
AdvisorShares Trust (NYSE ARCA:
PSIL) invests in the emerging psychedelic drugs
sector, offering exposure to those biotechnology, pharmaceutical
and life sciences companies the managers see as leading the way in
this nascent industry. PSIL concentrates its portfolio on companies
deriving the majority of their net revenue or devoting the majority
of their assets to psychedelic drugs. PSIL is considered an alpha
opportunity since it targets early growth in a nascent sector.
Horizons Psychedelic Stock Index ETF (NEO:
PSYK) was launched in January 2021, making it the
world’s first exchange traded fund focused on the emerging
psychedelics opportunity led by life science and pharmaceutical
companies. The ETF was created in response to a growing number of
public companies in North America adding to the body of clinical
research demonstrating the potential use of psychedelic compounds,
such as psilocybin and ketamine, as treatment for mental illness,
depression, addiction, PTSD, and other medical conditions.
On the back of strong investor appetite and hundreds of millions
of dollars in funding, psychedelic research is gaining sustainable
momentum and mainstream credibility. The days of viewing
psychedelics as merely amusements of counterculture are fading and
the very real possibility exists that novel psychedelic therapies
are on the horizon to help so many people in need that have been
failed by traditional drugs.
For more information about Mydecine Innovations, please
visit Mydecine
Innovations Group.
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