September 27, 2021 -- InvestorsHub NewsWire -- via NetworkNewsWire
Editorial Coverage: The emergence of psychedelic therapies as a
popular investment a few years ago was mostly underscored by
investors that rode the cannabis wave seeing a brand-new
opportunity with drugs such as psilocybin, LSD, MDMA, DMT, and
others to address hard-to-treat mental health diseases, namely
depression, addiction, post-traumatic stress disorder and anxiety.
As strides are being made on those fronts, a second investment wave
is swelling on the horizon that looks to feature expanded
indications and bring new therapeutic options to diseases with
unmet needs. Psychedelics could redefine standards of care for
chronic diseases and reshape psychiatry, including counseling
practices, among other things. Tryp Therapeutics Inc.
(CSE: TRYP)
(OTCQB:
TRYPF) (Profile) is leading this next wave of
psychedelic drug development beyond mental health into chronic pain
and eating disorders as the company advances its clinical programs.
With a diverse approach, Tryp is joined by a short list of brand
name leaders in psychedelics that includes ATAI
Life Sciences N.V. (NASDAQ:
ATAI), COMPASS Pathways
Plc (NASDAQ:
CMPS), Mind
Medicine (MindMed) Inc. (NASDAQ:
MNMD) (NEO:
MMED) (DE:
MMQ) and Cybin
Inc. (NEO:
CYBN) (NYSE American:
CYBN), all of which are making significant strides
towards validating the legitimate potential of a wide range of
psychedelic-based treatment regimens.
- Psychedelic drugs are amid a renaissance that will see revenues
rise from $2.82 billion in 2020 to $7.57 billion by 2028
- Tryp Therapeutics is pursuing five indications in chronic pain
and other indications with total estimated annual sales potential
of more than $12 billion
- Tryp has announced the submission of an investigational new
drug (“IND”) application for its Phase 2a clinical trial in
overeating disorders, is preparing to file another IND for a Phase
2a clinical trial targeting fibromyalgia
- Tryp has partnered with the University of Florida to conduct a
Phase 2a trial for overeating disorders, and with the University of
Michigan for its fibromyalgia clinical trial
Click here to view the custom infographic of
the Tryp Therapeutics
Inc. editorial.
New Opportunities Unlocking Value
Market analysts are bullish on the rapid growth in the global
psychedelic drugs market. Data Bridge
Market Research foresees a 13.3% compound annual growth
rate for the market to rise from $2.82 billion in 2020 to $7.57
billion by 2028. Analysts at Data Bridge see a rising prevalence of
depression and anxiety as key drivers. Again, while depression and
anxiety indeed represent blockbuster drug potential and huge
addressable markets, they are only scratching the surface.
On Wall Street, investors are putting premium dollars on
psychedelic companies within the biotech industry. Per Psilocybin
Alpha, the aggregate value of psychedelic companies listed on the
NYSE and NASDAQ exceeds $7
billion.
Innovative companies are looking outside the box to
differentiate themselves from the pack and capitalize on the robust
therapeutic properties of psychedelics. For instance, research is
underway to evaluate the use of psychedelics for Parkinson’s
disease, Alzheimer’s and other forms of dementia where there are
currently limited options with diminishing returns to address the
symptoms. While not being used for cancer, psychedelics are being
evaluated to help patients better manage grief associated with
cancer diagnoses.
Tryp
Therapeutics Inc. (CSE: TRYP)
(OTCQB:
TRYPF) is pursuing five indications in chronic pain and
other indications with total estimated peak worldwide sales
potential of more than $12 billion. Tryp expects to initiate two
Phase 2a studies in 2021 and two more in early 2022 focusing on
these indications. Despite four upcoming mid-stage clinical trials,
the company remains relatively unsung among its much higher
capitalized peers, as evidenced by a market capitalization under
C$25 million.
In addition to leading a second wave of innovation extending
beyond mental health disorders, Tryp distinguishes itself by
developing its proprietary psilocybin-based drug product. The
company’s drug candidates currently in development include
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.
Tryp can also trumpet an exclusive supply chain by which it
procures active ingredients and drug products in quantities
sufficient for clinical trials and commercialization, should the
drug be approved. This is a rare capability among psychedelic
drug-development companies. The integrated cGMP supply chain
affords Tryp another unique opportunity with potential to act as a
supplier of synthetic psilocybin to the global research
community.
Blockbuster Opportunities in Pain Treatment
ResearchandMarkets.com estimates revenue in the global chronic
pain treatment market to progress 6.5% annually from 2020 to
reach $151.7
billion in 2030. Tryp is focusing its efforts on areas of
unmet medical need in this space, targeting fibromyalgia, phantom
limb pain and complex regional pain syndrome, each of which are
blockbuster opportunities with the potential to generate over $1
billion in annual peak sales. Tryp intends to submit an
investigational new drug (“IND”) application with the FDA for
a Phase 2a
clinical trial with the University of Michigan in
fibromyalgia patients during Q4 of this year.
The National
Fibromyalgia Association estimates more than 10 million
Americans suffer from fibromyalgia. Existing treatments, such as
prescription opioids, exercise and stress management, are mostly
ineffective at best and deadly at worst considering opioids are
commonly prescribed to help patients with their pain. This is a
market ripe for disruption by psychedelics, with reason for
optimism as anecdotal
evidence is mounting that supports the potential
usefulness of psilocybin for fibromyalgia.
Going forward, Tryp intends to pursue clinical research in
phantom limb pain and complex regional pain syndrome (“CRPS”). It
is estimated that 1 million people in the United States suffer from
phantom limb pain, including more than 60% of
amputees. CRPS results from a misfiring of pain signals in the
brain after injury, surgery, stroke or heart attack. A rare
disease, about 200,000
people in the U.S. are affected by CRPS each year. As with
fibromyalgia, existing treatments leave a lot to be desired.
Overeating Disorders and a Major Milestone
After recently filing an IND application with the FDA, Tryp is
staring at another major milestone. The company anticipates that
its first clinical trial evaluating TRP-8802 will begin enrollment
and dosing patients in Q4 of this year. This Phase 2a study will
evaluate patients with overeating conditions including binge eating
disorder and hypothalamic obesity. For the trial, Tryp has
partnered with a leading expert in the eating disorder space, Dr.
Jennifer Miller at the University of Florida Division of
Endocrinology.
Affecting up to 3.5% of
females and 2.0% of males, binge eating disorder is a result of
addictive behaviors toward food that can be difficult for patients
to break. Hypothalamic obesity is characterized by damage to the
hypothalamus, the part of the brain that produces hormones that
control hunger. This disorder is estimated to affect less than
5,000 people in the U.S. every year, yet there are no available
treatment options for the disease. This means that Tryp could
potentially utilize all available accelerated FDA development
pathways.
Reaching Milestones Reduces Risk, Increases
Value
In the course of drug development, there are key milestones with
each human study including submitting an IND with and receiving
acceptance by the FDA; enrolling the first patient in the trial;
and then the final data readout at the end of a clinical trial. The
FDA’s expected green light to move forward with the University of
Florida study places Tryp in an elite group of companies conducting
Phase 2 trials for psychedelic drugs, and positions the company as
a pioneer in the field of psychedelics for chronic pain and
overeating disorders.
There are no assurances in clinical trials, but a drug moving
through the clinical progression tends to build value for a company
with each major milestone that is reached because of the potential
for future revenue. Effectively, 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.
Phase 1 studies are performed to prove a drug is safe. Phase 2
determines the efficacy at specific dosing levels for specific
indications. Phase 3 is similar to Phase 2 in purpose, only
evaluating larger patient populations. In Tryp’s case, the safety
profile of psilocybin is well established, meaning the company can
bypass Phase 1 and proceed right into Phase 2 trials. If the
company meets its goals of initiating four clinical trials by the
first half of 2022, Tryp could be on par with companies with market
capitalizations that are 10-fold (or more) larger than its own.
The Psychedelic Renaissance Is Now
The renaissance in psychedelic research is upon us after decades
of being on the back burner with a resurgence in clinical work that
has provided compelling data for mental health indications in
studies involving hundreds of patients. Look for that to continue
and for clinical studies to continue unlocking the therapeutic
potential of psychedelics beyond mental health.
ATAI
Life Sciences N.V. (NASDAQ:
ATAI) which counts PayPal founder Peter Thiel as
an investor, was founded in 2018 to accelerate development of
psychedelic drugs and companies. The Germany-based company has its
hands in many different drugs via investments in nearly a dozen
companies at various stages of development. On September 14, ATAI
announced the initiation of a Phase 2a clinical study to evaluate
the safety and efficacy of PCN-101 (R-ketamine). R-ketamine is a
stereoisomer of ketamine being developed for therapeutic treatment
of psychiatric disorders such as treatment resistant
depression.
COMPASS Pathways
Plc (NASDAQ:
CMPS) is one of the best-known names in the
psychedelics business. The company has the psychedelic community
watching for results from its Phase 2b clinical trial, which is the
largest human trial of synthetic psilocybin to date, enrolling 233
patients with treatment resistant depression across 22 sites in 10
countries. Topline data is expected during the fourth quarter.
Mind
Medicine (MindMed) Inc. (NASDAQ:
MNMD) (NEO:
MMED) was the third brand-name company to list on
Nasdaq over the past year, following COMPASS and ATAI. Most
recently MindMed has agreed to work with NASDAQ-listed Forian Inc.,
a leading provider of evidence-based support for more comprehensive
clinical and commercial decision-making. MindMed and Forian will
collaborate to develop best practices for using real-world evidence
information to help improve the health and lives of psychiatric
patients.
Cybin Inc. (NEO:
CYBN) (NYSE American:
CYBN), which has only been public since November 2020,
made the move to a senior exchange last month, graduating to the
NYSE American on August 5, 2021. Cybin’s current indications in its
psychedelic pipeline include major depressive disorder (CYB001),
alcohol use disorder (CYB003) and anxiety disorders (CYB004). In
addition, two programs in the research phase (CYB005 and CYB006)
involved synthesis and testing of more than 50 novel compounds
coupled with extensive in-vitro and in-vivo pharmacokinetic,
receptor binding, behavioral and safety evaluations.
For proponents, the stigma fading away from psychedelics is
brilliant progress allowing clinical trials to start reaching an
advanced stage. That means the world sits at an inflection point
and on the cusp of normalization of physician-administered
psychedelic drugs, and these are some of the companies that are
shepherding that transition.
For more information about Tryp Therapeutics, please
visit Tryp
Therapeutics Inc.
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