Revive
Therapeutics
Provides
Update on Psychedelics
Clinical
Product
Pipeline
-
Focusing
on novel uses, production and delivery forms of
psilocybin as a next generation solution
for mental illness, substance abuse and neurological
disorders
-
Advancing
to FDA clinical studies for
methamphetamine
use
disorder
and
stroke
TORONTO,
Canada -- August 10, 2021 -- InvestorsHub NewsWire
-- Revive Therapeutics
Ltd. ("Revive" or the "Company") (OTCQB:
RVVTF) (CSE:
RVV) (FRANKFURT:31R),
a specialty life sciences company focused on the research and
development of therapeutics for medical needs and rare
disorders,
is pleased to provide an update on the Company's
psychedelics
development
and clinical programs
with a focus on psilocybin.
Michael
Frank, CEO of the Company, commented, "We are
advancing a robust
psychedelics-based
product
pipeline that includes product
development, preclinical and clinical studies that aim
to unlock
the potential therapeutic
value
of psilocybin
in
various uses,
formulations
and
delivery methods
to
treat mental
health,
substance
abuse and
neurological disorders.
Revive
is
embarking
on the next stage of growth of
its
psychedelics
strategy
by focusing on building
key
partnerships
with US
academic institutions and other leading organizations, as well as
developing intellectual
property and
entering
into FDA clinical studies with
psilocybin."
Psilocybin in the Treatment of Methamphetamine Use
Disorder
The Company
is working with the
Board of Regents of the University of Wisconsin System
under
a
clinical
trial
agreement
to conduct a Phase I/II
clinical study
to evaluate the safety
and
feasibility
of
psilocybin
in
adults
with
methamphetamine
use
disorder.
Study start-up activities
have taken place and
enrollment
activities are to
continue throughout the remainder
of
the year.
As a result of the study, clinical
data
will
provide
proprietary and
valuable information on
the
safety,
efficacy
and dosing
of psilocybin
to support future pivotal FDA clinical studies in oral forms of
delivery including oral thin film
strips.
The clinical study will be conducted at the University of
Wisconsin-Madison, School of Medicine and Public Health and School
of Pharmacy, which holds a Wisconsin special authorization and DEA
license to perform clinical research with psilocybin.
In addition, the
Company will have exclusive access to key intellectual property
from this study
to support development, regulatory and commercial
initiatives.
Psilocybin in the Treatment of
Traumatic Brain Injury
(TBI)
and
Stroke
The Company
is advancing the research and intellectual property acquired
from PharmaTher
Holdings
Ltd. (OTCQB: PHRRF) (CSE: PHRM)
on
psilocybin
as
a
potential solution to managing
TBI
and
stroke. Preclinical
studies demonstrated
that
psilocybin, given after injury, improved cognitive function in TBI
mice. The Company
is proceeding to an FDA clinical
study to be
conducted
at the University of Wisconsin-Madison, School of Medicine and
Public Health and School of Pharmacy. Start-up
activities have already
begun
and
patient enrollment is expected to commence
in
Q4-2021.
Psilocybin
Oral
Thin Film Strip
Development
The Company has
initiated
the
product development program under
a feasibility agreement with LTS Lohmann
Therapie-Systeme
AG, a leader in pharmaceutical oral thin films, to develop and
manufacture a proprietary psilocybin
oral
thin film strip for mental illness,
substance abuse
and
neurological disorders.
Research grade prototypes will be available to evaluate dosing and
delivery rates in various dosage forms with the expectation
to
conduct clinical studies in 2022.
Psilocybin
Biosynthesis
Program
Under its
research collaboration with North
Carolina
State University (NC State), the Company is
developing a novel biosynthetic
version of psilocybin based on a natural biosynthesis enzymatic
platform developed by Dr. Gavin Williams, Professor and Researcher
at NC State.
The
biosynthetic platform developed by Dr. Gavin Williams provides a
potentially
simple
and efficient method for rapidly producing natural products, such
as psilocybin, using an engineered enzymatic pathway in E.
coli. Certain
technical
milestones have been
achieved to date, offering a clear path
towards completing
validation
methods
to
demonstrate
a novel
yet simple production process of biosynthetic psilocybin that
can be
used
at
a
critical
scale for clinical and commercial use.
Psilocybin International Research
and Commercialization
The Company recently entered into an agreement with the University
of Health Sciences Antigua to utilize
Revive's
novel psychedelic-assisted therapies
including its tannin-chitosan
delivery system
and
to
pioneer the clinical research and development of psychedelics in
Antigua and Barbuda.
Clinical research
will be conducted at the University in Q4-2021 with the aim for
commercialization in 2022 in Antigua and Barbuda. Once
approved for
sale, the Company will seek
commercial
partnerships
with specialty pharmaceutical companies in the Caribbean and Latin
America.
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. Through its
subsidiary 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.