Revive Therapeutics Enters into Clinical Trial Agreement to Evaluate Psilocybin for the Treatment of Methamphetamine Use Diso...
September 02 2020 - 8:16AM
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.
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