NetworkNewsWire
Editorial Coverage: Before government legislation brought the
world of psychedelic drug compounds to a halt, promising research
was being done in the space. As researchers and scientists took
closer looks at substances such as psilocybin, ketamine, DMT
(dimethyltryptamine), LSD (lysergic acid diethylamide) and more,
the potential for the compounds appeared to be widespread and even
life-changing for many who struggled with notoriously difficult
diseases such as depression, addiction, PTSD and more. And then the
Federal Comprehensive Drug Abuse Prevention and
Control Act of 1970, known as the Controlled Substance
Act, took effect. For decades, the promise of these substances has
remained ignored. However, with recent changes in legal guidelines
and swings in public opinion, astute researchers — and
companies — are showing renewed interest in the huge potential
of a sector that, to many, feels much like the cannabis space a few
years ago. Tryp Therapeutics Inc. (CSE: TRYP) (OTCQB:
TRYPF) (Profile) is one of the savvy companies
entering the public domain. Much like GW
Pharmaceuticals Plc (NASDAQ: GWPH) — which was
recently acquired by Jazz
Pharmaceuticals (NASDAQ: JAZZ) in a billion-dollar
transaction — pioneered the way in cannabis almost a decade ago,
Tryp is leading the way with its focus on researching potential
treatments for challenging disease through the use of naturally
occurring compounds. Other companies are following suit. Through
its Bioscience lab, Numinus
Wellness (TSX.V: NUMI) was the first public company in
Canada to receive a license to produce and extract psilocybin
from mushrooms, and the first to complete a legal harvest of
psilocybe mushrooms using this license. And Seelos
Therapeutics Inc. (NASDAQ: SEEL) just announced
positive data from its study evaluating ketamine as a treatment
option for acute suicidal ideation and behavior ("ASIB") in
patients with major depressive disorder ("MDD").
- Psychedelic therapeutics research market projected to reach
$10.75 billion by 2027.
- Tryp following path to psychedelic success laid out by cannabis
giant.
- Company’s primary indications are fibromyalgia, eating
disorders using its proprietary psilocybin formulation.
- Diversified pipeline includes nonpsychedelic drugs such as
Razoxane, which is in development for soft-tissue sarcomas.
Click here to view
the custom infographic of the Tryp Therapeutics
Inc. editorial.
Increased Interest, Escalating Evidence
In addition to federal regulations — or perhaps because of them
— the social stigma attached to psychedelics in the last decades of
the 20th century acted as a significant barrier to use of the
compounds. While many were familiar with the street names of these
much-disparaged substances, including magic mushrooms, ecstasy,
Molly and LSD, few were familiar with what they actually were or
what they did.
However, in recent years, tentative efforts have been made to
study these natural treatment options. With initial studies showing
promising results, increased interest has created a growing body of
scientific clinical evidence that points to psychedelics perhaps
being one of the greatest advancements in mental health and
neuropsychiatric disease in decades.
The escalating evidence of the value of psychedelics being added
to the array of medical options is following a path similar to that
of medical cannabis. In fact, a recent ResearchandMarkets.com
report projects 12.36%
compound annual growth for the psychedelics drug market, with
the market forecast to reach nearly $11 billion by 2027.
Led by a team of deeply experienced executives and advisors with
decades of involvement in drug development, Tryp
Therapeutics Inc. (CSE: TRYP) (OTCQB: TRYPF) is
forging the way forward as it focuses on taking natural compounds
from early stage and advancing them through the rigors of clinical
development to commercialization. This is where the comparison to
GW Pharma begins, with the now cannabis giant being founded by
experts in biotech and pharmaceutical development.
Faster, More Affordable Pipeline
Development
The comparison doesn’t end there. GW started with a focus on
pharmaceutical research of cannabinoids as potential treatments for
various diseases, and that focus grew into an impressive pipeline.
Tryp’s initial intent was to explore how psilocybin could be
utilized as a potential medical treatment, and those efforts have
grown into a strong pipeline with a focus on two active development
programs: Psilocybin-for-Neuropsychiatric Disorders, or PFN(TM),
for fibromyalgia, eating disorders and chronic pain conditions; and
Razoxane (TRP-1001) for soft-tissue sarcomas. The lead drug in the
PFN program is TRP-8802, a synthetic, oral psilocybin
medication.
To advance its pipeline, Tryp is involved in a collaboration
with University of Florida’s Jennifer Miller, MD. A professor of
pediatrics and endocrinology at the university, Miller is leading Tryp’s
phase 2 clinical trials, which are related to specific eating
disorders. Treatments for these types of eating disorders haven’t
evolved in many years, said Miller, and there is a heavy reliance
on daily medications.
“All of the currently available approved obesity and eating
disorder medications are daily medications,” she explained. “You
stop taking them, you stop having the efficacy. Our hope with
psilocybin [is that] once- or twice-a-year treatments will allow
these neural networks to rewire themselves and provide a more
chronic treatment, which doesn’t exist right now.”
In both clinical trials, Tryp is hoping for FDA 505(b)(2)
approval, which allows it to bypass preclinical and phase I studies
and move directly into phase 2 clinical trials. This streamlined
approach allows drug developers to use work done by others to
demonstrate the safety of a particular active ingredient. In this
way, Tryp intends to advance its development programs more quickly
and reduce costs so often required for successful drug
development.
Orphan Drugs Bring Billion-Dollar
Opportunities
Tryp is also eyeing the potential for orphan drug status in its
pipeline, once again following in the footsteps of GW Pharma. In
2014, GW Pharma received orphan
drug designation for Epidiolex(R), its product candidate that
contained plant-derived cannabidiol ("CBD") targeted for use in
treating children with Lennox-Gastaut syndrome ("LGS"); the company
also received orphan drug
designation in 2015 for cannabidiol ("CBD") for use in in
treating newborn children with neonatal hypoxic-ischemic
encephalopathy ("NHIE").
By definition, orphan indications are rare diseases with few
treatment options that impact fewer than 200,000
persons in the country. Receiving an FDA orphan drug
designation provides numerous incentives including expedited review
processes, tax credits, extended period of exclusivity and waived
fees, among others. Worldwide orphan-drug sales are forecast to
make up 20%
of the total prescription market in 2024 with sales reaching $242
billion.
Tryp is pursuing the
orphan drug pathway for its TRP-1001, an oral formulation of
razoxane for the treatment of soft-tissue sarcoma. Soft-tissue
sarcomas are rare tumors that account for only about 1% of all
cancers in adults and 7% in children.
Unmatched Leadership Team
Tryp’s leadership team is unmatched. Led by Gregory McKee, who
recently joined the company as CEO and executive chairman at Tryp,
the team also includes Tryp co-founder and director James Kuo, MD,
and president and chief science officer James Gilligan, PhD.
McKee brings 20-plus years of biotechnology,
life-sciences-management and venture-investment experience to the
company after filling executive positions with Torrent Ventures,
CONNECT, Nventa Biopharma (merged with Akela Pharma) and Genzyme
(acquired by Sanofi for $22 billion). Kuo has extensive experience
garnered from Pfizer, Discovery Labs, Myriad Genetics and as
current chairman of ImmunoPrecise. Gilligan brings more than 30
years of life-sciences experience to Tryp after co-founding Unigene
Laboratories and the Bracken Group.
And that’s just the tip of the leadership iceberg at Tryp. The
entire Tryp C-suite, board and advisory team touts similar resumes.
Key management execs have held top positions and leadership roles
at companies such as Pfizer, QLT, ImmunoPrecise Antibodies and
more. COO Tom D’Orazio has carefully guided two cancer drugs
through the Health Canada approval process, while vice president of
manufacturing Larry Norder oversaw the chemistry aspects of
early-stage R&D, preclinical and clinical developments for the
blockbuster Naproxen.
One of the world’s foremost experts in administration of
psychedelic compounds, Dr. Robin Carhart-Harris, recently joined
Tryp’s Scientific Advisory Board (SAB). Other new board members
include Dr. Joel Castellanos and Dr. William Schmidt, both leading
experts in drug development for chronic pain.
Diverse Pathways Offer Options
Companies and individuals looking to invest in innovation in
healthcare are finding possibilities in both diverse FDA pathways,
such as FDA 505(b)(2) approval and orphan drug distinctions, as
well as therapeutic psychedelics development.
GW
Pharmaceuticals Plc (NASDAQ: GWPH) has established a
global reputation as a pioneer in drug development, with its hugely
successful development of plant-derived cannabinoid therapeutics.
The company has become a leader in proven drug discovery and
development processes, intellectual property portfolio, and
regulatory and manufacturing expertise. In addition, GW Pharma has developed a deep pipeline of
additional clinical-stage cannabinoid product candidates under
development for both orphan and nonorphan indications with a
particular focus on neurological conditions.
In what it called a “milestone” move, Jazz
Pharmaceuticals (NASDAQ: JAZZ) earlier this month
announced the completion of
its acquisition of GW Pharmaceuticals PLC. "We are excited
to welcome our GW colleagues to Jazz as we mark a transformative
milestone in creating an innovative, high-growth, global biopharma
leader in neuroscience with a worldwide commercial and operational
footprint," said JAZZ chair and CEO Bruce Cozadd. "The
addition of GW further diversifies our commercial portfolio and
innovative pipeline with therapies that are complementary to our
existing business. . . . We are fortunate to be combining two
companies that share a passion for, and track record of, developing
differentiated therapies that advance science and the care of
patients with often-overlooked diseases.”
Numinus
Wellness (TSX.V: NUMI) has created a first-mover advantage that allows the company
to research and develop proprietary, standardized extraction
methods, testing methods and product formulations for use in
R&D partnerships, contract research services and clinical
trials. The company also possesses a dealer's
license from Health Canada to import, export, possess, test
and distribute MDMA, psilocybin, psilocin, DMT and mescaline.
Numinus also holds a cannabis testing license from Health
Canada, allowing the company to provide third-party analytics and
testing services for revenue generation.
Seelos
Therapeutics (NASDAQ: SEEL) recently announced
positive data
from its proof-of-concept study of SLS-002 (intranasal racemic
ketamine). The results included high response rates as well as
rapid, robust and sustained reduction in suicidality by all three
scales measuring suicidality. "There is no medication approved by
any regulatory agency for the treatment of suicidal ideation and
behavior in depression or in any mood disorder,” said David V.
Sheehan, MD, in the announcement. “This recent early phase 2 Seelos
open-label study data is a promising step towards achieving that
goal. If replicated in a larger placebo-controlled study, these
findings would be a historic contribution to the treatment of
suicidality."
Clearly the psychedelic wave is growing. With legislation
changing and social stigma easing, the once disgraced space is
gaining credibility and respectability — and even more important,
bringing potential and promise that change is on the healthcare
horizon.
For more information about Tryp Therapeutics,
please visit Tryp
Therapeutics.
About NetworkNewsWire
NetworkNewsWire
(“NNW”) is a financial news and content distribution company, one
of 50+ brands within the InvestorBrandNetwork (“IBN”), that
provides: (1) access to a network of wire
solutions via InvestorWire to
reach all target markets, industries and demographics in the most
effective manner possible; (2) article and
editorial syndication to 5,000+ news outlets; (3)
enhanced press release solutions to ensure maximum
impact; (4) social media distribution via IBN
millions of social media followers; and (5) a full
array of corporate communications solutions. As a multifaceted
organization with an extensive team of contributing journalists and
writers, NNW is uniquely positioned to best serve private and
public companies that desire to reach a wide audience comprising
investors, consumers, journalists and the general public. By
cutting through the overload of information in today’s market, NNW
brings its clients unparalleled visibility, recognition and brand
awareness. NNW is where news, content and information converge.
To receive SMS text alerts from NetworkNewsWire, text
“STOCKS” to 77948 (U.S. Mobile Phones Only)
For more information, please visit https://www.NetworkNewsWire.com
Please see full terms of use and disclaimers on the
NetworkNewsWire website applicable to all content provided by NNW,
wherever published or re-published: http://NNW.fm/Disclaimer
NetworkNewsWire (NNW)
New York, New York
www.NetworkNewsWire.com
212.418.1217 Office
Editor@NetworkNewsWire.com
NetworkNewsWire is part of the InvestorBrandNetwork
DISCLAIMER: NetworkNewsWire (NNW) is the source of the Article
and content set forth above. References to any issuer other than
the profiled issuer are intended solely to identify industry
participants and do not constitute an endorsement of any issuer and
do not constitute a comparison to the profiled issuer. The
commentary, views and opinions expressed in this release by NNW are
solely those of NNW. Readers of this Article and content agree that
they cannot and will not seek to hold liable NNW for any investment
decisions by their readers or subscribers. NNW is a news
dissemination and financial marketing solutions provider and are
NOT registered broker-dealers/analysts/investment advisers, hold no
investment licenses and may NOT sell, offer to sell or offer to buy
any security.
The Article and content related to the profiled company
represent the personal and subjective views of the Author, and are
subject to change at any time without notice. The information
provided in the Article and the content has been obtained from
sources which the Author believes to be reliable. However, the
Author has not independently verified or otherwise investigated all
such information. None of the Author, NNW, or any of their
respective affiliates, guarantee the accuracy or completeness of
any such information. This Article and content are not, and should
not be regarded as investment advice or as a recommendation
regarding any particular security or course of action; readers are
strongly urged to speak with their own investment advisor and
review all of the profiled issuer’s filings made with the
Securities and Exchange Commission before making any investment
decisions and should understand the risks associated with an
investment in the profiled issuer’s securities, including, but not
limited to, the complete loss of your investment.
NNW HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.
This release contains “forward-looking statements” within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E the Securities Exchange Act of 1934, as amended and
such forward-looking statements are made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995. “Forward-looking statements” describe future expectations,
plans, results, or strategies and are generally preceded by words
such as “may”, “future”, “plan” or “planned”, “will” or “should”,
“expected,” “anticipates”, “draft”, “eventually” or “projected”.
You are cautioned that such statements are subject to a multitude
of risks and uncertainties that could cause future circumstances,
events, or results to differ materially from those projected in the
forward-looking statements, including the risks that actual results
may differ materially from those projected in the forward-looking
statements as a result of various factors, and other risks
identified in a company’s annual report on Form 10-K or 10-KSB and
other filings made by such company with the Securities and Exchange
Commission. You should consider these factors in evaluating the
forward-looking statements included herein, and not place undue
reliance on such statements. The forward-looking statements in this
release are made as of the date hereof and NNW undertakes no
obligation to update such statements.
Source:
NetworkNewsWire
Contact:
NetworkNewsWire (NNW)
New York, New York
www.NetworkNewsWire.com
212.418.1217 Office
Editor@NetworkNewsWire.com
GW Pharmaceuticals (NASDAQ:GWPH)
Historical Stock Chart
From Nov 2024 to Dec 2024
GW Pharmaceuticals (NASDAQ:GWPH)
Historical Stock Chart
From Dec 2023 to Dec 2024
