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Editorial Coverage: Before 1970, promising research was being
conducted on the potential therapeutic effects of a broad category
of psychedelic drug compounds, including substances such as
psilocybin, DMT (dimethyltryptamine), LSD (lysergic acid
diethylamide) and MDMA (methylenedioxymethamphetamine) — and then
the Controlled Substance Act was signed into law, which labeled
those substances as drugs of abuse with no medical value. The
severely limited research conducted thereafter continued to
demonstrate the potential of these compounds to provide therapeutic
value, particularly for notoriously difficult diseases such as
depression, addiction, PTSD and others. In the past few years, the
relatively unattended field of psychedelic therapeutics is seeing a
revival of activity and excitement, spawning innovative approaches
and creating valuable companies in the process. Tryp
Therapeutics Inc. (CSE: TRYP) (OTCQB: TRYPF) (Profile) is one of the exciting new companies
to enter the public domain, bringing a diversified pipeline and
de-risked strategy that should usher the company right into phase 2
clinical trials. A public company since its IPO in December of
2020, Tryp aims to become a leader in the healthcare and drug
development industries alongside others, including COMPASS
Pathways Plc (NASDAQ: CMPS), Field
Trip Health Ltd. (OTCQX: FTRPF) (CSE: FTRP), Cybin
Inc. (NEO: CYBN) (OTCQB: CLXPF), Mind
Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO:
MMED).
- Psychedelic therapeutics research is on the rise with a few
companies standing out in a market forecast for 12.36% CAGR to
reach $10.75 billion by 2027.
- Tryp is led by pharmaceutical experts with backgrounds in drug
development utilizing FDA regulatory pathways.
- Tryp’s primary indications are fibromyalgia and eating
disorders using its proprietary psilocybin formulation.
- Tryp’s pipeline is diversified, including non-psychedelic drugs
like Razoxane, which is in development for soft tissue
sarcomas.
Click here to view
the custom infographic of the Tryp Therapeutics
Inc. editorial.
Goodbye Stigma, Welcome New Generation in
Healthcare
Most people may not recognize some of the medical terms for
psychedelics, but nearly all know their street names, including
magic mushrooms, ecstasy, Molly and LSD. Over decades, people have
been conditioned to the stigma of these illicit substances,
instigated and promoted by the Controlled Substances Act. However,
the negative stigma is being lifted and being replaced by a growing
body of scientific clinical evidence that strongly suggests
psychedelics may well become one of the greatest advancements in
mental health and neuropsychiatric disease in decades.
The mounting evidence of therapeutic value in psychedelics is
following a similar path as medical cannabis, with pockets of
decriminalization emerging in cities first with states following,
as Oregon became the first state to legalize medical psilocybin
(the active ingredient in magic mushrooms) in November. Likely just
the start of a wave of acceptance and medicinal use,
ResearchandMarkets.com forecasts 12.36%
compound annual growth for the psychedelics drug market and
expects the market to reach nearly $11 billion by 2027.
Tryp
Therapeutics Inc. (CSE: TRYP) (OTCQB: TRYPF) offers a
best-in-class, drug development team capable of taking compounds
from early stage and advancing them through the rigors of clinical
development to commercialization. This team of executives and
advisors cannot go understated as it’s made up of deep experience
and key leadership positions throughout, including large pharma,
emerging pharma, drug approvals, psychedelics and capital
markets.
Tryp will certainly benefit from the continued clinical research
and data being collected on psychedelics to treat mental health,
which further legitimizes efficacy. However, Tryp is not
immediately focused on treating depression or PTSD like many other
companies operating in the space. Management has the company
uniquely positioned by recognizing blockbuster opportunities that
exist in other indications with large unmet medical need that could
potentially be treated with psilocybin including fibromyalgia and
binge eating. Furthermore, Tryp has differentiated itself with a
diversified pipeline that also includes a well-understood oral drug
the company plans to develop for soft-tissue sarcomas.
Differentiated Indications and the Advantages of
505(b)(2)
Tryp’s multidimensional pipeline consists of its
Psilocybin-for-Neuropsychiatric Disorders (PFN(TM)) program and
Razoxane (TRP-1001) for soft-tissue sarcomas. The lead drug in the
PFN program is TRP-8802, a synthetic, oral psilocybin medication
initially being used to treat fibromyalgia, a condition of chronic
widespread pain with no known cause.
Tryp is also collaborating with University of Florida’s Jennifer
Miller, M.D. to initiate a clinical trial of TRP-8802 to treat the
symptoms associated with certain eating disorders. In both cases,
Tryp will be pursuing the FDA 505(b)(2) pathway to bypass
preclinical and Phase I studies and move directly into Phase 2
clinical trials. The 505(b)(2) pathway is a streamlined process
that allows drug developers to utilize work done by others to
demonstrate the safety of a particular active ingredient. Relying
on existing data eliminates unnecessary duplication of research and
can save a company millions of dollars and years of studies
compared to traditional pathways.
This is also the pathway Tryp will be seeking for TRP-1001 for
soft-tissue sarcomas ("STS"). Razoxane belongs to the family of
bis-dioxopiperazines, developed in the 1960s as derivatives of the
chelating agent EDTA. As such, Tryp has decades of research to
underpin and accelerate its development of TRP-1001 in a novel
process.
Orphan Drugs, Large-Market Opportunities
Tryp is taking advantage of this accelerated regulatory pathway
to develop treatments for both highly prevalent as well as rare
diseases. Fibromyalgia is a condition of chronic widespread
pain that impacts 6 to 12 million
Americans annually with no known cause. Common treatments
include muscle relaxants, antidepressants, anticonvulsants and
anti-inflammatory drugs. This is a $3.6 billion
market ripe for disruption as a new drug hasn’t been approved in
over a decade.
Eating disorders are a tremendous market opportunity considering
more than 30 million
Americans will suffer from one. Tryp’s study at the University
of Florida will also include hypothalamic obesity.
“Orphan” indications are rare diseases with few treatment
options that affect fewer than 200,000
persons in the United States. Receiving an FDA orphan drug
designation provides a bevy of incentives to a drug developer
including expedited review processes, tax credits, extended period
of exclusivity and waived fees, among others. Worldwide orphan-drug
sales are forecast to make up 20%
of the total prescription market in 2024 with sales reaching $242
billion.
Soft-tissue sarcomas ("STS") is another orphan indication
opportunity for Tryp. About 13,460 new
soft-tissue sarcomas will be diagnosed, and it is estimated
that 5,350 people will die of soft tissue sarcomas this year.
The disease also comprises 7% of all cancer diagnosis in
children.
World-Class Development Team
Gregory McKee recently came on as CEO and executive chairman at
Tryp, bringing more than two decades of biotechnology,
life-sciences-management and venture-investment experience to the
company after filling executive positions with Torrent Ventures,
CONNECT, Nventa Biopharma (merged with Akela Pharma) and Genzyme
(acquired by Sanofi for $22 billion). Tryp co-founder and director
James Kuo, MD, has extensive experience garnered from Pfizer,
Discovery Labs, Myriad Genetics and as current chairman of
ImmunoPrecise. President and chief science officer James Gilligan,
PhD, brings 35 years of life-sciences experience to Tryp after
co-founding Unigene Laboratories and the Bracken Group.
It is nearly impossible to adequately cover the entire Tryp
C-suite, board and advisory team, all of which boast resumes
similar to the aforementioned. Key members of Tryp management have
held top executive positions and leadership roles at companies such
as Pfizer, QLT, ImmunoPrecise Antibodies and many more. COO Tom
D’Orazio has taken two cancer drugs through the Health Canada
approval process. Vice president of manufacturing Larry Norder led
chemistry aspects of early-stage R&D, preclinical and clinical
developments for the blockbuster Naproxen. The impressive list goes
on and on.
The company also recently added Dr. Robin Carhart-Harris, one of
the world’s foremost experts in administration of psychedelic
compounds, to its Scientific Advisory Board ("SAB"); Dr. Joel
Castellanos and Dr. William Schmidt, both leading experts in drug
development for chronic pain, also joined the company’s SAB earlier
this year.
Tryp has attracted a team of luminaries and is on a collective
mission to provide relief for serious medical conditions that have
plagued the populace far too long without enough effective
solutions. A team of this caliber may well be the answer to
overcoming the magnitude of the problem.
Wall Street Wants In
The psychedelic revolution has begun. The evidence is
everywhere. Venerable organizations like Johns Hopkins University
and Imperial College of London are leading the charge and lending
ever more credence to the safety and efficacy of therapeutic
psychedelics. New venture firms are cropping up to pour cash into
the space. Non-profit MAPS, the Multidisciplinary Association for
Psychedelic Studies, late in 2020 raised $30
million from donors to conduct a Phase 3 clinical trial for
PTSD using MDMA-assisted psychotherapy and recently reported
positive results from the trial.
COMPASS
Pathways Plc (NASDAQ: CMPS) was one of the first
unicorns (companies with a $1 billion valuation) in the
psychedelics space. The London-based company is developing a
synthetic psilocybin (COMP360) administered in conjunction with
psychological support for treatment-resistant depression, which has
earned a vaunted breakthrough
therapy designation from the FDA. COMPASS expects to have data
from a phase 2b clinical trial for this indication by the end of
2021.
Field
Trip Health Ltd. (OTCQX: FTRPF) (CSE: FTRP) is taking
a different approach as a leader in the development and delivery of
psychedelic therapies. Its Field Trip Discovery division is working
on the next generation of psychedelic molecules and conducting
advanced research on plant-based psychedelics including
psilocybin-producing fungi. Its Field Trip Health division is
building centers for psychedelic therapies. The company this month
opened its fifth
location in the United States, with construction commencing in
other U.S. and Canadian cities.
Cybin
Inc. (NEO: CYBN) (OTCQB: CLXPF) recently disclosed
that it will be targeting
Alcohol Use Disorder as the initial indication for its
proprietary deuterated psychedelic tryptamine, CYB003, which is
being developed in collaboration with NYSE-listed Catalent. The
company has four psychedelics in its pipeline, including CYB001,
which is planned to be evaluated as a sublingually administered
version of psilocybin in Phase 2a and 2b clinical trials for Major
Depressive Disorder.
Mind
Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED) is
developing a diverse pipeline of psychedelic substances, including
psilocybin, LSD, MDMA, DMT and an Ibogaine derivative called 18-MC.
MindMed, which also has a valuation over $1 billion, last month
graduated from
the OTC to the NASDAQ, joining COMPASS as one of the few
big-board listed psychedelic companies. This month, MindMed
announced
Project Angie, a new program where it will begin looking at LSD
to treat pain conditions.
Those looking for innovation in healthcare are seeing it unfold
before their eyes today. The excitement for therapeutic
psychedelics is reaching a fever pitch as investors, academia, and
scientists alike are all starting to realize the potential for
psychedelics to change the healthcare landscape.
For more information about Tryp Therapeutics,
please visit Tryp
Therapeutics.
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