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Editorial Coverage: In May 2013, GW Pharma
listed on Nasdaq, selling 3.5 million shares at $8.90 each to
investors betting that GW was charting a profitable course as a
biotech developing new drugs from cannabis-derived compounds. Legal
cannabis was only beginning to gain momentum at that time, and
while countless companies saturated the market as would-be growers,
distributors, etc., GW was taking a more difficult route of drug
development with much greater upside if successful. The strategy
paid off as the company received FDA approval for the first-ever
cannabis-based drug in June 2018. There are some notable
similarities between the evolution of the legal cannabis market a
decade ago and the current status of psychedelics, longtime illicit
drugs that are now being evaluated for their therapeutic potential
by a handful of upstart companies. San Diego-based Tryp
Therapeutics Inc. (CSE: TRYP) (OTCQB: TRYPF) (Profile) stands out, not only for its
still-small valuation but also because it has a successful
management team that, much like GW, is charting its own course in
the space. Major investors have not been shy about speculating that
biotech is going to produce some psychedelic-derived blockbusters,
as evidenced by the attention given to COMPASS
Pathways Plc (NASDAQ: CMPS), Mind
Medicine ("MindMed") Inc. (NASDAQ: MNMD) (NEO: MMED) (DE:
MMQ) and newly public ATAI
Life Sciences N.V. (NASDAQ: ATAI), any one of which
could do for psychedelics what GW
Pharmaceuticals (NASDAQ: GWPH) did for cannabis before
being acquired in
February by Jazz
Pharmaceuticals plc (NASDAQ: JAZZ) for $7.2
billion.
- Venture capital has been pouring into psychedelics, rising from
under $100 million in investments in 2019 to $346 million in 2020
and already $329 million in 2021.
- Jazz Pharmaceuticals paying $7.2 billion for cannabis drug
maker GW Pharma has investors looking at early-stage psychedelic
companies.
- Tryp Therapeutics is one of only a handful of companies moving
into Phase 2 clinical trials with a psychedelic compound.
- Tryp has a seasoned management team, board of directors and
scientific advisory board with experience throughout the drug
development process.
Click here to view
the custom infographic of the Tryp Therapeutics
Inc. editorial.
Value Resides in Drug Development
A traditional biotech such as Jazz acquiring GW Pharma was a
bona fide inflection point for the cannabis industry, as
simultaneously a stamp of approval was put on both cannabis-derived
compounds and high valuations for drug-development companies
working with Schedule I drugs. GW was a true trendsetter with its
Epidiolex (cannabidiol) for controlling seizures in rare forms of
epilepsy. The new drug generated more
than $500 million in sales in 2020 and is expected to top $1
billion in the near future.
The brilliance of GW is that it used decades of anecdotal
evidence about cannabis to synthesize a natural cannabinoid for a
large market opportunity where conventional drugs have fallen
short. Unfortunately, President Richard Nixon signing the
Controlled Substance Act in 1970 put a damper on clinical research
of not only marijuana but psychedelic drugs as well, including
psilocybin (a compound of magic mushrooms), MDMA (known molly or
ecstacy), lysergic acid diethylamide (LSD or acid) and
N-Dimethyltryptamine (DMT), which all were lumped in as Schedule I
drugs deemed to have zero medical use.
A willingness from the FDA to evaluate cannabis-derived
compounds for their clinical merit has led to a resurgence in
clinical research proving this categorization wrong, not to mention
lending to a shift in removing the negative stigma of cannabis in
favor of what could be transformational medical advancements for
areas of great unmet need. A similar trend is underway with
psychedelics, which are already benefiting from the path carved by
cannabis drug development pioneers such as GW.
This month’s IPO of atai
Life shines a spotlight on the growing interest in the
drug-development side of the space. The company raised more than
$200 million through a U.S. initial public offering comprised of 15
million common shares priced at $15 and targeting a valuation of
approximately $2.3 billion.
Big Pharma Comes to Psychedelics
Many companies are angling to capitalize on the emergence of
psychedelics for therapeutic indications, but only a select few
pharmaceutical companies are entering Phase 2a clinical trials,
including Tryp
Therapeutics Inc. (CSE: TRYP) (OTCQB: TRYPF). Tryp’s pipeline
is comprised of its Psilocybin-for-Neuropsychiatric Disorders, or
PFN, program that includes TRP-8802, the initial oral formulation
of psilocybin for Tryp’s Phase 2a clinical trials, and TRP-8803, a
proprietary formulation with novel method of administration planned
to be used for Phase 2a trials.
With world-class management and advisors, Tryp is advancing its
PFN program into Phase 2a clinical studies, a derisking factor not
seen in most peers. Furthermore, Tryp is differentiated by
evaluating indications outside the limited mental health conditions
that others in the space are pursuing.
Tryp’s leadership is one that is fitting for a major
pharmaceutical company. The executive
team has degrees from some of the nation’s top institutions
including University of Pennsylvania’s Wharton School, Loyola,
Univeristy of Connecticutt, Notre Dame, BYU and Vanderbilt to
provide a sampling. Before making their foray into psychedelics
with Tryp, management experience has come from careers founding or
holding leadership positions at the likes of Genzyme, Unigene,
Tarsa Therapeutics, Dow Chemical, ImmunoPrecise, ConSynance, DelMar
Pharmaceuticals and many more.
The company’s board of directors and advisory team mirror the
same type of credentials. In aggregate, the company has decades of
experience in drug development from the bench to commercialization
and capital markets; its scientific advisory board is led by Robin
Carhart-Harris, PhD, and has expertise in everything from
pscyhedelics and the initial target indications of pain management
and eating disorders. Leveraging the network of the team, Tryp has
partnered with
Albany Molecular Research for manufacturing services for synthetic
psilocybin and Alcami for analytical methods and final formulations
in preparation for clinical trials.
Eating Disorders and Chronic Pain on Tap
Tryp is pursuing two indications representing large
opportunities that have proven mostly elusive to conventional
drugs. Eating disorders have been particularly difficult, even
against the backdrop of 9% of the global
population (a figure consistent in the United States)
developing an eating disorder at some point in their lives. Tryp
has partnered with the University of Florida to conduct a Phase 2a
trial of TRP-8802 for patients suffering from rare and other
overeating disorders where there are extremely limited or no
treatment options available today. Jennifer Miller, MD, a professor
in the division of pediatric endocrinology at University of
Florida, is serving as the trial’s principal investigator.
Expectations are that patients with binge eating and
hypothalamic obesity will respond favorably to the neuroplasticity
effects of TRP-8802 in combination with psychotherapy. These types
of eating disorders have limited treatment options, and Tryp has
partnered with
Fluence to provide design and training for the
psychotherapeutic portion of its clinical studies.
Pain Market Ripe for Disruption
Keeping with its theme akin to the GW approach of targeting
difficult or unattended diseases and disorders with a fully
synthesized regulated compound, Tryp is also developing TRP-8802
for chronic pain conditions, including fibromyalgia, phantom limb
pain and complex regional pain syndrome. These are maladies that
affect millions of people as part of a global chronic pain market
forecast to grow 6.5% annually to reach $151.7 billion in 2030. The
fibromyalgia treatment market alone is expected to exceed $3.6
billion by 2026.
Perhaps no other market is ripe for innovation like that of
chronic pain, where opioids and other drugs with well-known
negative side effects and addictive properties dominate. A safe and
effective alternative has blockbuster potential. Clinical trials
are being planned to evaluate if TRP-8802 can modulate chronic pain
through action in the descending pain inhibitory pathway and
increased neuroplasticity. The chronic pain indications that
Tryp has selected share a common characteristic of having pain
signals that originate from the central nervous system rather than
from localized trauma.
Follow the Money to Drug Development
It’s encouraging to see the large amount of capital being
deployed to support innovation in drug development for compounds
derived from cannabis and psychedelics. According to CB Insights,
venture capital investment has been growing dramatically in the
last few years, rising from under $100 million in 2019 to $346
million in 2020 and already $329 million
in 2021. Following the money shows that a large portion of
investment capital is being directed to companies pursuing
regulated drug development of these compounds for medical
indications.
COMPASS
Pathways Plc (NASDAQ: CMPS), a U.K.-based company with
a patented synthetic version of psilocybin for use in
treatment-resistant depression, is indicative of investors’
appetite. COMPASS is advancing its psilocybin therapy program under
an FDA Breakthrough Therapy designation awarded in 2018 and has
recently
published additional information on the strong safety profile
of its treatment. The company completed its initial public
offering in September, selling 7.5 million shares priced at $17
each, above the expected range of $14-$16 for a market cap nearing
$1 billion. By mid-December shares of CMPS were at a record high of
$61.69.
Mind Medicine
("MindMed") Inc. (NASDAQ: MNMD) (NEO: MMED) (DE: MMQ),
which listed on Nasdaq in April, is taking a multidisciplinary
approach to psychedelics. The company is extremely active in its
development efforts. For instance, in recent weeks,
the New York-based company has added multiple team members,
received approval from the local Swiss ethics committee for a
mescaline study and completed its pre-IND meeting with the FDA to
select generalized anxiety disorder as the initial indication for
its upcoming Phase 2b trial for its LSD therapy.
ATAI
Life Sciences N.V. (NASDAQ: ATAI) has been the talk of
the psychedelics space lately. The German company, which counts
PayPal founder Peter Thiel as one of its biggest investors,
completed its IPO this
month, raising $225 million by pricing shares at the high end
of the range at $15 each. ATAI is different than others insomuch
that it is effectively a holding company that invests in companies
developing mental health treatments, currently overseeing 10
therapeutic programs, including five using different types of
psychedelic chemistries.
Jazz
Pharmaceuticals plc (NASDAQ: JAZZ) is a prime example
of commitment to the emerging cannabis drug-development market,
recently paying $7.2 billion in cash and stock for GW Pharma. With
U.S. sales of Epidiolex topping $500 million last year and the
recent launch in Europe under the brand name Epidyolex, management
is expecting the franchise to cross $1 billion in annual sales in
the near term. Moreover, Jazz is conducting research of Epidiolex
for additional indications, which will not only add to corporate
coffers should they reach commercialization, it will also lend
further validation to the legitimacy of cannabis-derived compounds
to further strengthen the chemistry’s reputation as a medicine.
The aforementioned companies are instrumental to a growing body
of research proving the therapeutic benefits of psychedelics and
other Schedule 1 compounds, which is a welcome development to
millions of patients who are currenty suffering from diseases with
limited and ineffective treatment options.
For more information about Tryp Therapeutics,
please visit Tryp
Therapeutics Inc.
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Tryp Therapeutics (CSE:TRYP)
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