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Editorial Coverage: It’s early on in a burgeoning market, but
there is certainly reason to be optimistic about the future of
psychedelic medicines as a promising treatment for a broad spectrum
of diseases and conditions. In fact, some breakthroughs may be
closer than initially anticipated. After decades of stigma from
their recreational use, psychedelics are now gaining momentum for
medical applications as the U.S. Food and Drug Administration has
signaled its intent to evaluate the compounds based on the merit of
their clinical efficacy. The range of target indications is
widening, the number of studies for different types of psychedelics
is growing and specialized clinics are cropping up, a trio of
signals that approved medical applications of psychedelics may be
here before long. The diversity of approaches makes the market
particularly interesting for psychedelic market participants. For
instance, Tryp Therapeutics (CSE: TRYP) (OTCQB: TRYPF)
(Profile) is studying how its novel
technologies address chronic pain and eating disorders — two areas
that have been particularly elusive for traditional drug
makers. Seelos Therapeutics Inc. (NASDAQ:
SEEL) is looking at a new spin on ketamine for
certain types of depression, while Awakn Life Sciences Corp. (NEO:
AWKN) and Field Trip Health Ltd. (TSX: FTRP) (OTCQX:
FTRPF) are in the clinics and R&D businesses,
and Small Pharma Inc. (TSX.V:
DMT) is evaluating other psychedelics for
depression.
- Most psychedelic drug developers are working on drugs for
mental illness, particularly depression; Tryp is targeting chronic
pain and eating disorders.
- Tryp Therapeutics is advancing novel drug candidates made from
psilocybin, the psychedelic component found in magic
mushrooms.
- Tryp expects to submit two separate INDs this year for upcoming
Phase 2a clinical trials.
- Only an elite group of companies have initiated Phase 2
clinical trials exploring psychedelic-related compounds; those
companies’ valuation ranges from $85 million to $2.5 billion versus
Tryp’s $31 million.
Click here to view the custom infographic of
the Tryp Therapeutics
Inc. editorial.
Psychedelic Catalysts
Psychedelics reached an inflection point in 2018 when the FDA
tagged psilocybin, the hallucinogenic compound found in “magic”
mushrooms, with a Breakthrough Therapy designation to treat
depression in patients who didn’t meaningfully respond to two
different types of antidepressant therapies. The vaunted
designation is a priority review pathway reserved for new drugs
believed to offer a substantial improvement over anything on the
market today. The designation lent a great deal of credence to a
compound still categorized as a Schedule I drug under the
Controlled Substance Act, a categorization that restricts the use
of the compound and criminalizes its possession outside of medical
applications. A second Breakthrough Therapy designation
followed in November 2019 for the treatment of major depressive
disorder.
Tryp
Therapeutics (CSE: TRYP) (OTCQB: TRYPF) is optimistic that
psilocybin can be beneficial in other large markets where patients
and doctors alike are eager to see alternatives to the lackluster
drugs available today. Headquartered in San Diego, California, Tryp
has assembled a team of
veritable experts in its C-suite and scientific advisory
board, which is chaired by Dr. Robin Carhart-Harris, one of the
world’s leading minds in psychedelic medicines. Dr. Carhart-Harris
also serves as director of the Neuroscape Psychedelic Division at
the University of California, San Francisco as well as founder and
head of the Centre for Psychedelic Research, Division of Brain
Sciences, at Imperial College London where his work was part of
which supported the first
Breakthrough Therapy designation for psilocybin.
Tryp’s TRP-8802 and TRP-8803 are the flagship products of the
company’s Psilocybin-for-Neuropsychiatric Disorders, or PFN
program. TRP-8802, a standard oral form of synthetic psilocybin, is
being developed for several different indications, including
chronic pain (more specifically, fibromyalgia) and eating
disorders. TRP-8803 is a patent-pending psilocybin-based product
being developed by Tryp with a unique formulation and novel route
of administration. The expectation is that TRP-8803 will be able to
improve the experience for patients receiving psychedelic therapies
versus that of conventional oral administration. Tryp will be using
TRP-8802 for its Phase 2a clinical trials and expects to use
TRP-8803 for Phase 2b studies and beyond.
The development strategy involves leveraging the known safety
and pharmacokinetic profiles of psilocybin to jump right into Phase
2a trials — a stage of studies that aims to demonstrate the
efficacy of psilocybin for the targeted indications. To do so, Tryp
has teamed up with leading companies whose expertise will be
invaluable in its development. Curia (formerly AMRI) is
manufacturing the active pharmaceutical ingredient (“API”) for the
synthetic psilocybin that is the basis for the PFN program. Alcami
will develop the analytical methods and final drug products.
Fluence is handling the psychotherapy designs for the trials.
Clinlogix has been retained as the Contract Research Organization
(“CRO”) for the planned Phase 2a studies. Furthermore, Tryp is
partnering with world-leading academic institutions to conduct the
trials: the Chronic Pain & Fatigue Research Center at the
University of Michigan for fibromyalgia and the University of
Florida for eating disorders.
Time for New Pain Relief
As companies position themselves for different indications with
different compounds, Tryp is a first mover with plenty of runway to
pull away in the areas of chronic pain and certain eating
disorders. Within the chronic pain category, Tryp has its sights
initially set on fibromyalgia, a common (~4 million U.S. patients),
complex disease characterized by widespread
musculoskeletal pain, fatigue, body tenderness, memory
problems and sleep disorders. A true pioneer, Tryp has
partnered with the University of Michigan to lead the
world’s first Phase 2 clinical trial for a chronic pain indication
using a psychedelic compound.
The source of fibromyalgia is not known, but one commonly
accepted overarching thesis is that people with the condition
process pain differently. Without addressing the source,
painkillers are commonly prescribed, but only mask the pain.
Unfortunately, that puts fibromyalgia patients at risk of opioid
addiction and falling into an opioid epidemic that
claims more than
50,000 American lives by overdose annually. Looking at the
stats shows how badly this market needs safer alternatives.
Approximately 30% of fibromyalgia patients (~1.2 million Americans)
are prescribed opioids for their pain. After a year of therapy,
owing to ineffectiveness and unpleasant side effects,
only about
10% are following their physician’s care plan.
Tryp intends to have an Investigational New Drug (“IND”)
application filed with the FDA this quarter for the upcoming Phase
2a trial with the University of Michigan. The university will also
conduct research to advance the development of TRP-8803 for the
purpose of expanding Tryp’s patent portfolio and for use of
TRP-8803 in Phase 2b and subsequent trials.
Disrupting Eating Disorders
With eating disorders affecting an estimated 9% of the world’s
population, including nearly 29 million Americans, it’s a
significant market opportunity. However, traditional biotechs and
pharmaceutical companies can claim minimal success at best in
conquering eating disorders. When it comes to binge eating disorder
(“BED”), a primary target of Tryp, Vyvance, an ADHD drug by Shire
with an expanded indication approved in 2015, is the only drug on
the market specific to the disease.
Tryp plans to have an IND application submitted to the FDA for a
Phase 2a trial evaluating TRP-8802 in patients with BED and
hypothalamic obesity. The University of Florida’s Dr. Jennifer
Miller is serving as the principal investigator in the
trial. Miller is world-renowned for her expertise in eating
disorders and has
affirmed that patients face a dearth of treatment options
to help with their afflictions.
Markets Reward Phase 2
Tryp is one of an elite group to reach Phase 2 research with a
psychedelic drug compound, so initiating multiple Phase 2a trials
this year represents a major milestone. Early-stage drug developers
are typically valued based on advancing drug candidates towards
commercialization since revenue and earnings are absent. With each
completed phase in the FDA process, risk of failure is reduced,
odds of an FDA approval are increased, and market value rises
appropriately. When it comes to mid-stage studies, valuation have
been shown to increase
fourfold upon successfully completing Phase 2 clinical
trials.
To date, seven public companies have initiated Phase 2 studies
for a psychedelic-based therapy. The majority are targeting
depression, which is not surprising given the library of anecdotal
and clinical research supporting the potential to make an impact
where conventional drugs have mostly failed. For those companies
making the list, there is a wide range of market valuations,
ranging from $85 million to $2.5 billion. As it looks to commence
Phase 2 trials, Tryp has a market capitalization of approximately
$31 million.
Depression, Addiction, Clinics and More
This has already been a big year for psychedelics, with no signs
that momentum will begin to wane anytime soon given the uptick in
research. In addition to Tryp, a small group of companies are
distinguishing themselves as pioneers in the space.
Seelos Therapeutics Inc. (NASDAQ:
SEEL) is a member of the Defiance Next Gen
Altered Experience ETF, the first U.S.-listed Exchange Traded Fund
focused on psychedelics. The company has a diverse pipeline that
includes non-psychedelic assets but earned its spot in the ETF for
its lead program of 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 in patients with major depressive
disorder (“MDD”).
Awakn Life Sciences Corp. (NEO:
AWKN) has a multiprong business strategy,
including clinical operations and research into developing a
pipeline of next-generation therapeutics to treat addiction with a
near-term focus on ketamine, a medium-term focus on MDMA, and a
long-term focus on Awakn’s
own developed drugs. This month, Awakn said it will undertake a
program of clinical research designed to demonstrate the
effectiveness for ketamine-assisted psychotherapy against multiple
addictions, including alcohol use disorder (“AUD”) and gambling
addiction.
Field Trip Health Ltd. (TSX: FTRP) (OTCQX:
FTRPF) is known as a global leader in the
development and delivery of psychedelic therapies. The
company’s Field Trip Discovery division develops psychedelic
molecules and conducts advanced research on plant-based
psychedelics, while the Field Trip Health division builds centers
for psychedelic therapies opening across North America and Europe
along with the digital and technological tools to facilitate
scaling.
Small Pharma Inc. (TSX.V:
DMT) is a neuropharmaceutical company focused on
psychedelic-assisted N,N-dimethyltryptamine (“DMT”)
therapies. Small
Pharma is planning to initiate a Phase 2a trial to
evaluate its SPL026 product for depression by the end of the year
and has launched a training program to educate psychologists on the
process required for the support and completion of Small Pharma’s
DMT-assisted therapy clinical trials.
Like any emerging market, psychedelic stocks have certainly had
their ebbs and flows of attention and excitement. We are now
beginning to see more separation among the field of psychedelic
participants as speculation gives way to more fundamental analysis
of the companies’ drug development pipelines and the unique
indications they are pursuing. And we are just scratching the
surface with understanding the medical potential of psychedelic
medicines for the millions of patients who need them most.
For more information about Tryp
Therapeutics, please visit Tryp
Therapeutics Inc.
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