Revive
Therapeutics Enters into Clinical Trial Agreement to Evaluate
Psilocybin for
the
Treatment of Methamphetamine Use Disorder
TORONTO,
September 2,
2020 -- 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 that the Company
has entered into a Clinical Trial Agreement
(CTA),
dated August 28,
2020,
with the Board of Regents of the University of Wisconsin System
(UWS) to conduct a clinical study entitled,
"Phase I Study of the Safety and Feasibility of Psilocybin in
Adults with Methamphetamine Use Disorder."
Under the terms of the CTA, the Company has an exclusive option
to obtain an exclusive, worldwide,
royalty-bearing commercialization license to all rights, title and
interest that UWS
may
have or
obtain in any invention that results
from the clinical
study.
"We
are delighted to be collaborating with clinical researchers
at
the
University of Wisconsin?Madison
to advance development of psilocybin for the potential treatment of
methamphetamine use disorder," said Michael Frank, Revive's Chief
Executive Officer. "We are building a pipeline of clinical-stage
psychedelic-derived
therapies
for addiction disorders with a focus on psilocybin with unique
dosage forms."
Christopher R. Nicholas, Ph.D.,
Assistant Professor
at the
University of Wisconsin School of Medicine and Public Health,
and
clinical psychologist
at the school's
Program for Research Outreach Therapeutics and Education in the
Addictions
("PROTEA")
in the Department of Family Medicine and Community Health, will
serve as
principal
investigator
for
this initial safety
study. The study will be conducted at the University of
Wisconsin
Schools
of Medicine and Public Health and Pharmacy, which hold a Wisconsin
special authorization and Drug
Enforcement Administration
license to perform clinical research with psilocybin.
Members of the
PROTEA team previously conducted research on the pharmacokinetics
of high-dose
psilocybin and are also currently investigating psilocybin as a
treatment for opioid use disorder.
About Methamphetamine Use Disorder
Methamphetamine use disorder occurs when someone experiences
clinically significant impairment caused by the recurrent use of
methamphetamine, including health problems, physical withdrawal,
persistent or increasing use, and failure to meet major
responsibilities at work, school or home. According to the
Substance Abuse and Mental Health Services Administration's
(SAMHSA) 2018 National Survey on Drug Use and Health, there are
approximately 1.1 million people aged 12 or older who have a
methamphetamine use disorder in the U.S. Based on the most recent
year for which data
is
available, the economic cost in the U.S. is approximately $23
billion,
according to data from the
Rand Corporation. There is no pharmaceutical treatment approved for
methamphetamine dependence and the current treatment strategy is
behavioral therapies, such as cognitive-behavioral and contingency
management interventions.
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 Food and Drug
Administration (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 have reviewed or accept 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 Offering, including the
intended use of proceeds. 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, 2019, which has been filed on SEDAR and is available
under the Company's profile at
www.sedar.com.
