March 2, 2022 -- InvestorsHub NewsWire -- via NetworkNewsWire
Editorial Coverage: 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.
Click here to view the custom infographic of
the Cybin Inc. editorial.
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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