Revive
Therapeutics Provides
Update on Cannabinoid Pharmaceuticals Program
TORONTO,
Feb.
11,
2021 -- InvestorsHub NewsWire -- Revive Therapeutics Ltd.
("Revive" or the "Company") (CSE: RVV, USA: RVVTF), a specialty life sciences company
focused on the research and development of therapeutics for medical
needs and rare disorders, is pleased to
provide a corporate update on its cannabinoid pharmaceuticals
program specifically as it relates to the clinical
development of Cannabidiol ("CBD") in the
treatment of rare
diseases and the Company's
novel drug delivery technology.
Revive
has built
a
portfolio of U.S. Food and Drug Administration ("FDA") orphan drug
designations for
CBD
that
support
the long-term potential of cannabinoid prescription medicines for
rare diseases and disorders, which the Company believes has been
validated by the FDA approval of the GW Pharmaceuticals plc
EPIDIOLEX® product
and the
recently announced acquisition of GW
Pharmaceuticals by Jazz
Pharmaceuticals for $7.2 billion.
For
its
rare disease cannabinoid
product
pipeline, Revive was
granted
in the
past by the
FDA two
orphan drug designations for CBD in the treatment of
autoimmune hepatitis, a rare liver disease, and CBD in the
prevention of ischemia and reperfusion injury ("IRI") resulting
from solid organ transplantation, such as liver, kidney, heart and
lung.
Revive
recently
entered
into a clinical trial agreement with The Trustees of Indiana
University ("TIU ")
to develop and manage a proposed Phase
2 clinical study
entitled, "Use of Cannabidiol as an adjunct therapy for
difficult to treat
autoimmune hepatitis." TIU and the Company are in the process of
completing the protocol and study documents for
submission of a pre-Investigational New
Drug ("IND") meeting with the
FDA. Upon the receipt of permission from the FDA to
proceed
with the study under an IND, the Company will proceed to evaluate a
potential study with CBD for ischemia/reperfusion
injury and other liver
diseases.
There
are over 100 described diseases of the liver affecting at least 30
million people alone in the U.S. A number of factors are driving
the liver disease treatment market, which includes rapidly changing
lifestyle patterns such as increasing alcohol consumption,
unhealthy diets, and increasing prevalence of liver diseases. Liver
diseases can result from injury to the liver caused by hepatitis C
virus (HCV), hepatitis B virus (HBV), obesity, chronic excessive
alcohol use or autoimmune diseases. Major drug categories used in
the treatment of liver diseases includes anti-rejection drugs,
vaccines, immunosuppressant, chemotherapy drugs and antiviral
drugs. According to Allied Market Research, titled, "World Liver
Disease Treatment Market - Opportunities and Forecast, 2014 -
2022", the global market for liver disease treatment is projected
to reach approximately $19.5 billion by 2022.
As
previously announced, the Company is
developing its novel drug delivery technology for psychedelics and
cannabinoids under
a research agreement with the University of
Wisconsin-Madison.
This
includes hydrogel
formulations in
combination with synthetic CBD
which
was
evaluated in an
anti-inflammatory preclinical model and
successfully
demonstrated a stable formulation with
anti-inflammatory
activity complementing
the
mode of action of CBD.
The CBD
hydrogel based on the delivery systems novel tannin-chitosan
composite successfully demonstrated the control of synthetic CBD
permeability through the simulated skin membrane, thus increasing
the time for its availability and enabling the potential to be
developed as a controlled or sustained release delivery system that
may lead to single-dose treatments. The delivery technology shows
potential to deliver both synthetic cannabinoids and natural
extracts of cannabis in a potential number of ways such as topical
gels, creams or ointments, oral or transdermal patches, and oral
dosages.
The
delivery technology is a natural, non-toxic, biodegradable and
biocompatible composite that combines a tannin material, which is
derived from a plant group having antibacterial, antifungal,
antioxidant and wound healing properties, and a chitosan material,
which is derived from the crustacean group having blood-clotting
and antimicrobial properties. The delivery technology has rapid
onset of action and controlled or sustained release potential
capabilities and may allow to combine multiple cannabinoids or
cannabis extracts in one formulation, which unlocks the potential
to develop novel products that target large
dollar
market opportunities such as pain (i.e. neuropathic, joint pain),
inflammatory skin disorders (i.e. acne, psoriasis), wound healing
applications (i.e. battle wounds, scarring) and liver
diseases.
"We
have a unique portfolio of CBD-based pharmaceutical programs with
validated research results which allowed
for the FDA to grant us
orphan drug
designation in both
autoimmune hepatitis and organ transplants as well as a novel drug
delivery technology that has demonstrated the ability to formulate
CBD in a hydrogel enabling the efficient and controlled delivery of
CBD through the skin, thus
unlocking
significant market
opportunities in inflammatory skin disorders
and
wound healing applications," said Michael
Frank, CEO of Revive. "Over the last year,
we
have
evolved in focusing our clinical development programs in high
demand pharmaceutical
industries such as
psychedelics, cannabinoids and infectious diseases
that
leverages
our
expertise in drug repurposing and drug delivery to enhance
shareholder value."
About
Revive Therapeutics Ltd.
Revive
is a life sciences company focused on the research and development
of therapeutics for infectious diseases and rare disorders, and it
is prioritizing drug development efforts to take advantage of
several regulatory incentives awarded by the FDA such as Orphan
Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease
designations. Currently, the Company is exploring the use of
Bucillamine for the potential treatment of infectious diseases,
with an initial focus on severe influenza and COVID-19. With its
recent acquisition of Psilocin Pharma Corp., Revive is advancing
the development of Psilocybin-based therapeutics in various
diseases and disorders. Revive's
cannabinoid pharmaceutical portfolio focuses on rare inflammatory
diseases and the company was granted FDA orphan drug status
designation for the use of Cannabidiol
(CBD)
to treat autoimmune hepatitis (liver disease) and to treat ischemia
and reperfusion injury from organ transplantation. For more
information, visit
www.ReviveThera.com.
For more information, please contact:
Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: mfrank@revivethera.com
Website: www.revivethera.com
Neither the Canadian Securities Exchange nor its Regulation
Services Provider has reviewed or accepts responsibility for the
adequacy or accuracy of this release.
Cautionary Statement
This press release contains 'forward-looking information' within
the meaning of applicable Canadian securities legislation. These
statements relate to future events or future performance. The use
of any of the words "could", "intend", "expect", "believe", "will",
"projected", "estimated" and similar expressions and statements
relating to matters that are not historical facts are intended to
identify forward-looking information and are based on Revive's
current belief or assumptions as to the outcome and timing of such
future events. Forward looking information in this press release
includes information with respect to the
the Company's cannabinoids, psychedelics and infectious diseases
programs.
Forward-looking information is based on reasonable assumptions that
have been made by Revive at the date of the information and is
subject to known and unknown risks, uncertainties, and other
factors that may cause actual results or events to differ
materially from those anticipated in the forward-looking
information. Given these risks, uncertainties and assumptions, you
should not unduly rely on these forward-looking statements. The
forward-looking information contained in this press release is made
as of the date hereof, and Revive is not obligated to update or
revise any forward-looking information, whether as a result of new
information, future events or otherwise, except as required by
applicable securities laws. The foregoing statements expressly
qualify any forward-looking information contained herein. Reference
is made to the risk factors disclosed under the heading "Risk
Factors" in the Company's annual MD&A for the fiscal year ended
June 30, 2020, which has been filed on SEDAR and is available under
the Company's profile at www.sedar.com.
