Revive
Therapeutics Announces
Successful
Research Results for
Oral
Thin Film Psilocybin and
Filing
of U.S.
Provisional
Patent
Application
TORONTO,
April
22,
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 announce
the
successful completion of
the research
results and filing of
a U.S.
provisional patent
application with The
United States Patent and Trademark Office ("USPTO")
on
an
oral
thin-film ("OTF")
delivery system
with psilocybin developed under a research partnership
agreement ("Research
study") with Reed Research
Group at
the
University of Wisconsin-Madison.
This
novel
OTF offers
a
unique delivery
of psilocybin
as a potential treatment
option
for mental illness,
neurological
and substance abuse disorders.
The
objective of the Research study was to
determined
thatif
psilocybin could be
incorporated into chitosan-tannin composite hydrogel solutions,
cast into molds, form stable flexible thin films after drying, and
release psilocybin upon dissolution in water. University
of Wisconsin-Madison's Reed Research
Group
successfully demonstrated that psilocybin (dissolved in water or
ethanol) can be incorporated into chitosan-tannin hydrogel
solutions, cast into molds,
and
dried to create a flexible thin film. The OTF psilocybin product
dissolved in water (<5 minutes) with
dosage
forms ranging between 1 mg and 20 mg.
Revive is in discussion with a leading OTF contract manufacturer to
assist in the clinical scale-up
and
manufacturing of the
OTF psilocybin product. Future
studies with the OTF
psilocybin product will
include
evaluation in
humans
under
U.S. Food and Drug Administration ("FDA") Phase I and II clinical
studies
as a potential treatment in
various
mental illness,
neurological
and substance abuse disorders.
As a
result of the Research study, the Wisconsin Alumni
Research Foundation (WARF), the technology transfer office for
the University of
Wisconsin-Madison,
submitted a
provisional patent application to the
UPTSO,
entitled "Composite Chitosan-Tannin-Active Agent Compositions and
Methods of Making and Using Same".
At a high level,
the
provisional patent
application describes
tannin-chitosan
composite OTF incorporating
active pharmaceutical ingredients, such as
psilocybin.
There
are a number of advantages and benefits of an orally dissolvable
psilocybin thin film such as the rapid dissolving and onset of
action to the bloodstream, the ease and convenience for patients to
administer without the need of water, chewing or swallowing, the
potential of improved therapeutic outcomes and efficacy for
underserved diseases and disorders including the flexibility to
create accurate dosing and tasteful options.
Michael
Frank, CEO of Revive commented:
"We
are pleased with the final conclusion of
the Research studywork
and its
successful results
as
it validates our drug
delivery technology in delivering psychedelic pharmaceuticals
and positions our oral
thin film psilocybin
product
to become a potential
novel treatment solution for various mental
illness,
neurological and substance abuse
disorders. We continue
to focus on building our intellectual property
portfolio, advancing our
psychedelics-based
product
pipeline to clinical
trials and partnering
with leading
institutions, such as University of Wisconsin-Madison,
which
recently pioneered the only master's program of its kind in the
U.S. in therapeutic use of psychoactive drugs."
The Company cautions that psilocybin is still under early-stage
research and development and is not making any express or implied
claims as to their success in the treatment of mental
illness,
neurological
and substance abuse disorders or commercial viability.
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.
