September 29, 2021 -- InvestorsHub NewsWire -- NetworkNewsWire
Editorial Coverage: The fact that psychedelics is a nascent
industry doesn’t seem to be discouraging savvy investors exploring
the opportunities. A recent Fortune
article noted that “despite being an industry in its early
stages, the potential for psychedelic health care is
growing, with the market projected to reach $10.75
billion by 2027. . . . Smart capital is moving in to take advantage
of the opportunity to invest in the next frontier.” The
multibillion-dollar potential combined with solid promise in
psychedelic drug treatments, particularly in the hard-to-treat
mental health sector, such as depression, addiction, post-traumatic
stress disorder and anxiety, bodes well for pioneering psychedelic
companies, including Tryp Therapeutics Inc. (CSE: TRYP)
(OTCQB:
TRYPF) (Profile). Tryp is one of a handful of
companies focused on psychedelics; others venturing forward in the
space include Seelos Therapeutics Inc. (NASDAQ:
SEEL), Field Trip Health Ltd. (TSX: FTRP) (NASDAQ:
FTRP), Small Pharma Inc. (TSX.V:
DMT) and Mydecine Innovations Group Inc (OTC:
MYCOF).
- Psychedelic drugs projected to see revenues rise from $2
billion in 2019 to $6.8 billion by 2028.
- Tryp Therapeutics is pursuing chronic pain and other
indications that extend beyond mental health with total estimated
annual sales potential of more than $12 billion.
- Tryp has submitted an investigational new drug (“IND”)
application for its Phase 2a clinical trial in overeating
disorders, and plans to file an IND for a Phase 2a clinical trial
targeting fibromyalgia.
- Tryp is partnering with the University of Florida on Phase 2a
trial for overeating disorders and with the University of Michigan
for a fibromyalgia clinical trial.
Click here to view the custom infographic of
the Tryp Therapeutics
Inc. editorial.
Growing Acceptance
The Fortune article noted that projections for the psychedelic
industry vary, with a recent Data Bridge Market Research reporting
that the market is growing with a CAGR of 16.3% from 2020 to 2027,
expected to reach $6.8 billion by 2027, up from $2 billion in 2019.
Another report from Research and Markets was even more optimistic,
forecasting that the psychedelic drugs market would reach $10.75
billion by 2027, growing at a CAGR of 12.36% during
2021–2027.
“Growing acceptance of psychedelic drugs for treating depression
and increasing prevalence of depression and mental disorders are
the factors for the market growth,” the article stated.
Psychedelic pioneers are working to establish strongholds in the
space, confident that research and popular opinion will dovetail,
creating an ideal place to be in mental health treatment. Studies
focused on the seemingly vast potential of psychedelics increase
almost daily as savvy companies look to leverage their strengths
and make the most of new breakthroughs. Recent research has focused
on using psychedelics for the treatment of Parkinson’s disease,
Alzheimer’s and other forms of dementia, which currently offers
limited options with diminishing returns to address the symptoms.
Psychedelics are even being studied for potential in helping
patients better manage grief associated with cancer diagnoses.
Tryp
Therapeutics Inc. (CSE: TRYP) (OTCQB: TRYPF) is leveraging
its expertise as it pursues indications in chronic pain and other
indications with estimated worldwide sales potential totaling more
than $12 billion. Tryp plans to focus on these indications with two
Phase 2a studies scheduled for this year, with two more planned for
early 2022. Even with the potential provided from its four upcoming
mid-stage clinical trials, the company appears to be overlooked
among its much higher capitalized peers, as evidenced by a market
capitalization under C$25 million.
Clinical trials aren’t the only way Tryp is setting itself
apart. The company is in the process of developing a proprietary
psilocybin-based drug product, with two drug candidates currently
in development: TRP-8802, a standard oral form of synthetic
psilocybin, and TRP-8803, a patent-pending formulation with a novel
route of administration that is expected to improve the patient
experience.
In addition, Tryp boasts an exclusive supply chain by which it
obtains active ingredients and drug products in quantities
sufficient for its slated clinical trials as well as planned
commercialization. This is a rare feat among psychedelic
drug-development companies as the supply chain is deeply impacted
by numerous factors. Tryp’s integrated cGMP supply chain is yet
another component of the company’s potential to act as a supplier
of synthetic psilocybin to the global research community.
Focused on Areas of Unmet Need
A recent ResearchandMarkets.com report estimated revenue in the
global chronic pain treatment market to increase 6.5% annually from
2020 to 2030, when it is projected to total $151.7
billion. Those numbers provide an attractive backdrop for Tryp,
which is focusing its efforts on areas of unmet medical need in
this space.
Specifically, the company is eyeing the fibromyalgia, phantom
limb pain and complex regional pain syndrome (“CRPS”) spaces, each
of which look to provide blockbuster opportunities with potential
to generate more than $1 billion in annual peak sales. Tryp
anticipates submitting an investigational new drug (“IND”)
application with the FDA in Q4 for a Phase 2a
clinical trial focused on fibromyalgia patients. The
company is conducting the study with the University of Michigan
with the enrollment of first patients for the study expected in
2022.
Recent stats from the National
Fibromyalgia Association indicate more than 10 million
Americans suffer from fibromyalgia. Common treatments include
prescription opioids, exercise and stress management, which are
often ineffective at best and even deadly, considering opioids are
commonly prescribed to help patients with their pain. This sector
is ripe for psychedelic innovation, especially as anecdotal
evidence appears to strongly support the potential power
of psilocybin to treat the condition.
In addition, Tryp plans to pursue clinical research in phantom
limb pain and complex regional pain syndrome (“CRPS”). Reports
indicate that 1 million people in the United States suffer from
phantom limb pain, including more than 60% of
amputees. A relatively rare disease, CRPS is rooted in a
misfiring of pain signals in the brain after injury, surgery,
stroke or heart attack; an estimated 200,000
people in the U.S. struggle with CRPS each year. As with
fibromyalgia, current treatments could be improved upon.
Moving Toward Milestones
After recently filing an IND application with the FDA, Tryp is
also moving toward another major milestone later this year. The
company plans on enrolling and dosing patients in its first
clinical trial evaluating TRP-8802. This Phase 2a study will study
patients with overeating conditions such as binge eating disorder
and hypothalamic obesity. Tryp is working with a leading expert in
the eating disorder space, Dr. Jennifer Miller at the University of
Florida Division of Endocrinology, to conduct this trial.
Binge eating disorder impacts up 3.5% of
females and 2.0% of males and is an addictive food
behavior that is difficult for patients to stop. Hypothalamic
obesity is characterized by damage to the hypothalamus, the part of
the brain that produces hormones that control hunger. While
affecting fewer than 5,000 people in the United States every year,
the disease has no available treatment options, creating an open
opportunity where Tryp could potentially utilize all available
accelerated FDA development pathways.
Joining an Elite Group
Critical milestones in the process of drug development and human
studies include submitting an IND with and receiving acceptance by
the FDA; enrolling the first patient in the trial; and then
gathering final data readout at the end of a clinical trial. The
FDA’s expected approval to move forward with the University of
Florida study means Tryp joins an elite group of companies
conducting Phase 2 trials for psychedelic drugs, positioning the
company as a pioneer in the field of psychedelics for chronic pain
and overeating disorders.
While there are no sure things in clinical trials, having a drug
moving through the clinical progression often builds value for a
company, especially as the study moves through each major
milestone. The potential for future revenue increases while the
risk profile decreases incrementally with each positive
development, so shares rise, much like Nasdaq-listed Vaxart’s did
on August 2, 2021, with an IND approval.
Briefly, successful Phase 1 studies prove a drug is safe, Phase
2 determines the efficacy at specific dosing levels for specific
indications and Phase 3 is similar to Phase 2 in purpose but
evaluates larger patient populations. In Tryp’s case, the safety
profile of psilocybin is well established, meaning the company can
skip Phase 1 and proceed right into Phase 2 trials. If Tryp meets
its goals of initiating four clinical trials by the first half of
2022, the company could be on par with companies with market
capitalizations that are 10-fold (or more) larger than its own.
A Promising Space
The new frontier of psychedelics has arrived with growing
popular acceptance and a significant increase in research has
provided compelling data for mental health indications in studies
involving hundreds of patients. It is evident that now is the time
for both savvy investors and companies to consider the potential
for this promising space.
Seelos Therapeutics Inc. (NASDAQ:
SEEL) is a clinical-stage biopharmaceutical
company focused on the development of therapies for central nervous
system disorders and rare diseases. This summer, the company
announced that it was included in
the first U.S.-listed Exchange Traded Fund (“EFT”) focused
on psychedelics. The fund began trading on May 28, 2021. Seelos’
inclusion in the fund was based on its lead program SLS-002
(intranasal racemic ketamine), which recently released positive
top-line data from Part 1, the open-label cohort, of its
potentially registrational proof-of-concept study for acute
suicidal ideation and behavior (“ASIB”) in patients with major
depressive disorder (“MDD”).
Small Pharma Inc. (TSX.V: DMT), a
neuropharmaceutical company focused on psychedelic-assisted
therapies, has also been included in
an inaugural ETF. The company announced that AdvisorShares(R)
Investments LLC, a leading sponsor of actively managed
exchange-traded funds, has included Small Pharma in the launch of
its AdvisorShares Psychedelics ETF (“PSIL”). In addition, Small
Pharma has released
information regarding the successful completion of the
Phase I part of the combined Phase I/IIa clinical trial and the
initiation of the Phase IIa part in combination with psychotherapy
of its lead candidate, SPL026, for the treatment of major
depressive disorder.
Field Trip Health Ltd. (TSX: FTRP) (NASDAQ:
FTRP) has announced
that the lead indications for FT-104, its novel
psychedelic compound in development, will be treatment resistant
depression (“TRD”) and postpartum depression (“PPD”). A global
leader in the development and delivery of psychedelic therapies,
Field Trip is developing next-generation psychedelic molecules. Its
first molecule in development, FT-104, a prodrug, is a synthetic
serotonin-2A (5HT2A) agonist whose active component has
serotonin-2A potency similar to psilocybin.
Mydecine Innovations Group Inc (OTC:
MYCOF) has filed its
final patent application with the United States Patent and
Trademark Office and the World Intellectual Property Organization
for one of its lead drug candidates, MYCO-003. In addition, the
company reported positive preclinical data supporting the continued
development of MYCO-003. This patent-pending formulation has the
potential to further reduce patient anxiety as compared to pure
psilocybin, when used in therapy or medical practice. Mydecine, a
biopharmaceutical company focused on the treatment of mental health
and addiction, is developing MYCO-003 to offer enhanced treatment
of anxiety and post-traumatic stress disorder (“PTSD”).
As psychedelic research continues to move forward and clinical
trials start reaching advanced stages, companies operating in this
space will likely gain additional attention from investors,
patients and health providers alike.
For more information about Tryp Therapeutics, please
visit Tryp
Therapeutics Inc.
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