Revive Therapeutics Provides Update
of Psilocybin Pharmaceutical Programs
IRB approval to initiate Phase 2
study for methamphetamine abuse disorders
Advancing psilocybin oral thin
film, microneedle patch and biosynthesis programs
TORONTO, January 17, 2022 -- 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 psilocybin
pharmaceutical development programs.
"Revive is
building a specialty psilocybin-based product pipeline to treat
mental illness, substance abuse and neurological
disorders. We are embarking on our first clinical
study evaluating psilocybin in the treatment of methamphetamine use
disorder and advancing the development of an oral psilocybin thin
file strip and psilocybin microneedle patch, which will offer
flexible therapeutic solutions of psilocybin for unmet medical
needs."
Psilocybin for
Methamphetamine Use Disorder
The Company is evaluating
psilocybin as a potential treatment for methamphetamine use
disorder with the University of Wisconsin-Madison through a
clinical trial agreement. Under
an investigator-initiated IND, led by Dr.'s Christopher Nicholas
and Paul Hutson, the Phase I/II clinical study to evaluate the
safety and feasibility of psilocybin in adults with methamphetamine
use disorder received Institutional Review Board ("IRB")
approval. 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 the Company's
proposed oral psilocybin thin film strip. The clinical study will
be conducted at the University of Wisconsin-Madison, School of
Medicine and Public Health and School of Pharmacy. In addition, the
Company will have exclusive access to key intellectual property
from this study to support development, regulatory and commercial
initiatives.
Psilocybin for
Stroke
The Company is evaluating
psilocybin as a potential treatment for stroke with the University
of Wisconsin-Madison. Under the same investigator-initiated IND,
led by
Dr.'s Christopher Nicholas and Paul Hutson, the proposed Phase I/II clinical study
protocol to evaluate the safety and feasibility of psilocybin for
stroke is expected to be submitted to the IRB in
February. 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 the Company's proposed oral psilocybin thin
film strip. The clinical study will be conducted at the University
of Wisconsin-Madison, School of Medicine and Public Health and
School of Pharmacy. In addition, the Company will have exclusive
access to key intellectual property from this study to support
development, regulatory and commercial initiatives.
Psilocybin Oral Thin
Film Strip
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 prototype development is
underway to support IND-enabling studies with the expectation to
conduct a clinical study in Q4-2022.
Psilocybin
Microneedle Patch
The Company entered into a research collaboration agreement
with PharmaTher Holdings Ltd. ("PharmaTher") (OTCQB: PHRRF) (CSE:
PHRM) to evaluate the delivery of psilocybin with PharmaTher's
proprietary microneedle patch technology for neuropsychiatric
disorders. The project plan has
been finalized and the Company will initiate IND-enabling studies
with the expectation to conduct a clinical study in
Q4-2022.
Psilocybin
Biosynthesis
The Company is developing a
novel biosynthetic version of psilocybin based on a natural
biosynthesis enzymatic platform under its research collaboration
with North Carolina State University developed by Dr.
Gavin Williams, Professor and Researcher at NC State. The
biosynthetic platform 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. The Company expects to
complete a research-grade batch of psilocybin for research in
Q2-2022 with the aim to conduct clinical studies in
2023.
Psilocybin
International Research
The Company 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 is expected to begin shortly 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. With its
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, 2021, which has been filed on SEDAR and is available under
the Company's profile at www.sedar.com.