July 27, 2021 -- InvestorsHub NewsWire -- via NetworkNewsWire
Editorial Coverage: In July 2012, Congress created what is
known as Breakthrough Therapy designation, a distinction that
affords biotechnology and pharmaceutical companies an expedited
review process for experimental drugs that may have treatment
advantages over existing therapies for hard-to-treat diseases. In
November 2013, Gazyva, a drug used in combination with chlorambucil
for patients with chronic lymphocytic leukemia, made history as the
first breakthrough therapy to receive FDA marketing approval. Since
then, hundreds of drugs have earned the designation, and several
have reached commercialization. An area that remains
underrepresented on the FDA breakthrough therapy list that could
make waves in the coming years is that of the emerging market of
psychedelics, where companies such as Tryp
Therapeutics (CSE: TRYP)
(OTCQB: TRYPF)
(Profile) is striving to
provide relief for patients with chronic pain by developing
evidence-based innovation in areas where today’s approved drugs and
therapies are lacking. Tryp is part of a select group of companies
that are advancing or have already advanced psychedelic treatments
into Phase 2 of the FDA clinical trial process, a small collection
of impressive companies that includes COMPASS Pathways Plc (NASDAQ:
CMPS), Mind
Medicine (MindMed) Inc. (NASDAQ:
MNMD) (NEO:
MMED) (DE:
MMQ), ATAI
Life Sciences N.V. (NASDAQ:
ATAI) and Cybin Inc. (NEO: CYBN) (OTCQB:
CLXPF).
- The majority of companies in the psychedelic space are pursuing
mental illnesses, with a particular affinity for depression.
- Tryp Therapeutics is a first mover, developing a proprietary
psilocybin product for two different areas with significant unmet
medical need: chronic pain and eating disorders.
- Tryp intends to submit investigational new drug applications
(“IND”) to the FDA in the second half of this year.
- Only seven companies have initiated Phase 2 clinical trials
using psychedelic compounds and their market capitalizations range
from $85 million to $2.7 billion — Tryp’s market cap is ~$30
million.
Click here to view the custom infographic of
the Tryp Therapeutics
Inc. editorial.
Opportunity Beyond Mental Illness
Many companies in the psychedelics space are leveraging data
(historical, recent and anecdotal) that suggest psychedelics can be
beneficial for mental disorders and diseases. These indications
include post-traumatic stress disorder (“PTSD”), anxiety, attention
deficit-hyperactivity disorder (“ADHD”) and different types of
depression, to name a few mental illness targets. These
indications, particularly depression, are receiving tremendous
attention because they represent tens of millions of patients
craving medication or therapy that is more efficacious with fewer
unpleasant side effects than what is currently available.
While it is common knowledge that the use of psychedelic
medicines such as peyote and psilocybin to produce healing effects
dates back thousands of years, modern-day research was stymied by
the Controlled Substances Act of 1970 that classified psychedelics
as Schedule I drugs with no medical use. In the last few years, the
stigma has been lifted, and research has accelerated with some
promising results, such as Johns Hopkins Medicine showing that two
doses of psilocybin, the psychoactive compound in “magic”
mushrooms, in combination with psychotherapy produced a reduction
in symptoms for adults with major depression.
While depression is a hot-button indication for several
different psychedelic companies, Tryp
Therapeutics (CSE: TRYP)
(OTCQB:
TRYPF) is confident that psilocybin can be effective in
treating several other underserved indications, namely chronic pain
and certain eating disorders. The San Diego-based company has
assembled a seasoned management team and group of world-class
advisors to lend their expertise in developing new drug candidates
for chronic pain and eating disorders as part of Tryp’s
Psilocybin-for-Neuropsychiatric Disorders, or PFN program. Tryp is
using a standard oral form of synthetic psilocybin, its TRP-8802
product, for its initial Phase 2a clinical trials to demonstrate
the efficacy of the compound across several indications.
Tryp is also developing a proprietary, psilocybin-based product,
TRP-8803, with a novel formulation and unique route of
administration. Tryp has already filed a provisional patent to
protect the novel aspects of TRP-8803, which is expected to improve
patients’ experiences with being treating with psychedelic
compounds compared to standard oral doses.
To bring its drug products into Phase 2 clinical trials, Tryp is
working with companies with world-class expertise in their
respective fields. The company has partnered with Fluence on
psychotherapy designs and is working with Clinlogix as the contract
research organization for its upcoming clinical trials. Curia
(formerly AMRI) is manufacturing the active pharmaceutical
ingredient for synthetic psilocybin that forms the basis of the PFN
program, while Alcami has been contracted to develop the analytical
methods and final drug products for Tryp. Most significantly, Tryp
has announced upcoming Phase 2a clinical trials with the Chronic
Pain & Fatigue Research Center at the University of Michigan
for fibromyalgia and with the University of Florida for eating
disorders.
Pain: An Indication Begging for Innovation
Tryp appears to be differentiated from its group of peers in its
target indications. The company’s decision to break new ground in
different diseases may prove quite prescient, as it is now a
first mover in both chronic pain and certain eating disorders. As
it happens, these are two potentially lucrative markets where
traditional drugs seem to have fallen short in effectively treating
the diseases. In chronic pain, the lack of effective treatments
often drives patients to seek relief for their pain through
addictive substances such as opioids that fail to treat the cause
of the pain, a dangerous pattern given the more than
50,000 American lives claimed by opioid overdoses each
year. The market is ripe for disruption.
Tryp recently
announced that it will be conducting a Phase 2a clinical
trial for fibromyalgia and has partnered with the Chronic Pain
& Fatigue Research Center at the University of Michigan — the
world’s first Phase 2 clinical trial for a chronic pain indication
using a psychedelic chemistry. Nearly
30% of fibromyalgia patients are using opioids to address
their symptoms, and existing medications that have already been
approved for fibromyalgia can be ineffective and induce significant
side effects, resulting in only
10% of patients continuing to use the therapies after one
year. Tryp expects to advance directly to Phase 2a clinical studies
based on the significant amount of published data available on the
safety of psilocybin and plans to file an Investigational New Drug
(“IND”) application with the FDA for its fibromyalgia trial this
quarter.
The University of Michigan will also be
performing studies to advance the development of Tryp’s
proprietary drug product, TRP-8803. The studies will expand Tryp’s
intellectual property portfolio and will help bridge the use of
TRP-8803 in subsequent Phase 2b studies and ultimate
commercialization. Tryp is eager for its products to reach
patients, potentially offering help in alleviating the suffering
they experience from fibromyalgia and other chronic pain
indications.
Eating Disorders: Starving for New Choices
In addition, Tryp is targeting an IND submission this quarter
using TRP-8802 for an upcoming Phase 2a clinical trial for eating
disorders including binge eating and hypothalamic obesity. Tryp
will be collaborating with Dr. Jennifer Miller of the
University of Florida as the principal investigator for the
clinical trial. Miller is a world-renowned expert in these eating
disorders and has
affirmed that there are currently no approved drugs and
only limited options to treat patients with rare over-eating
disorders.
There has been little progress by pharmaceutical companies to
develop effective treatments for eating disorders. Vyvance is an
ADHD drug that Shire parlayed in 2015 into the first and only drug
FDA approved for binge eating disorder (“BED”), one of the primary
disorders Tryp is targeting in its upcoming trial. Both Tryp and
Miller believe that patients may respond favorably to the
neuroplasticity effects of TRP-8802 to help break the cycle of
hunger impulses within the brain and establish new neural
connections that normalize the patient’s relationship with
food.
Markets Value Phase 2 Progress
Tryp will be initiating multiple Phase 2a clinical trials this
year, an important milestone in the path toward commercializing its
products. Drug-development companies are typically valued based on
their progress toward commercialization rather than on revenue or
earnings multiples; with each phase of clinical trials that are
successfully completed, the likelihood of the drug product being
approved to market by the FDA increases, the risk of failure is
reduced, and the value of the company therefore increases. For
example, the valuation of drug-development companies
can increase by
four times upon the successful completion of Phase 2
studies.
Given the nascency of the psychedelics market, there are only a
handful of companies – seven to be exact – that have initiated
Phase 2 studies. For those companies, market capitalizations range
from about $85 million to $2.7 billion, providing a little color as
to how the markets value companies with Phase 2 psychedelic assets.
Tryp’s valuation is currently around $30 million.
Psychedelic Investing: A Trip for Everyone
The psychedelic drug-development market is maturing, and
momentum will continue to build as new companies report on
successful clinical trials. This is one of those rare occasions
where groundbreaking opportunities abound for the benefit of
patients and investors alike as an array of drug-development
companies work to realize the medical potential of
psychedelic-based therapies.
COMPASS Pathways Plc (NASDAQ:
CMPS) is one of the first companies to focus
exclusively on drug development using psilocybin. In October
2018, COMPASS was the first to receive breakthrough
designation for a psychedelic from the FDA using a psilocybin
therapy for treatment-resistant depression. In June 2021, COMPASS
completed psilocybin administration to 216 patients in its Phase 2b
clinical trial of COMP360 psilocybin therapy for
treatment-resistant depression, marking the world’s largest
psilocybin therapy trial to date. The company says it is on track
to deliver top-line results from the trial later this year.
Mind
Medicine (MindMed) Inc. (NASDAQ:
MNMD) (NEO:
MMED) (DE:
MMQ), which recently uplisted to Nasdaq, is a
clinical-stage biotech working on a diverse portfolio of
psychedelic substances for addiction and mental illness. The
company is evaluating several psychedelic chemistries including
psilocybin, LSD, MDMA, DMT and 18-MC, a derivative of
ibogaine. MindMed has initiated Phase 2 clinical trials in
anxiety and ADHD.
ATAI
Life Sciences N.V. (NASDAQ: ATAI) is the
highest-valued psychedelic drug-development company with a robust
portfolio and $2.7 billion market cap. The German biotech is a
holding company for several start-ups conducting research with
psychedelics for various mental illnesses. ATAI leverages its decentralized platform
approach to incubate and accelerate companies, which include a
strategic investment in COMPASS and 10 of its own programs
targeting PTSD, treatment-resistant depression, opioid-use
disorder, cognitive impairment associated with schizophrenia,
general anxiety and mild traumatic brain injury.
Cybin Inc. (NEO: CYBN) (OTCQB:
CLXPF) is focused on progressing psychedelic
therapeutics by utilizing proprietary drug-discovery platforms,
innovative drug-delivery systems, novel formulation approaches and
treatment regimens for psychiatric disorders.
Toronto-based Cybin’s
lead drug program is CYB001, a sublingual film psilocybin product
for major depressive disorder. A Phase 2a clinical trial will
evaluate five different dosing regimens across 40 patients before
the study advances into a Phase 2b study that is expected to enroll
120 patients.
It is an exciting time for the psychedelic drug-development
industry, with new trials coming online and results from the
biggest clinical trial yet expected in the coming months, which has
potential to catalyze the entire sector.
For more information about Tryp
Therapeutics, please visit Tryp
Therapeutics Inc.
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