Revive
Therapeutics Provides
Update on FDA
Phase
3 Clinical Trial
for Bucillamine
in COVID-19 with
Planned
Completion
and
Emergency Use Authorization Request
TORONTO,
February
26,
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
an
update on the Company's U.S. Food & Drug Administration
("FDA")
Phase 3 clinical trial (the "Study") to evaluate the safety and
efficacy of Bucillamine in patients with mild to moderate
COVID-19.
With
its recent $23 million
dollar financing,
the Company
plans
to aggressively expand
from
14
clinical
sites
to
up
to 50
clinical sites to meet the next
enrollment
goals
for
the Study in
Q2-2020.
The Study is
a
randomized, double-blinded,
placebo-controlled
trial and the safety and efficacy data
analyzed
at each
interim analysis
timepoint
of
210,
400, 600 and 800
completed
patients
are only made available to the Independent Data and Safety
Monitoring Board ("DSMB")
for review and recommendations on continuation, stopping or changes
to the conduct of the Study. In the event of any
serious safety concerns, the DSMB would be notified to determine
any risks and provide its recommendations. To date,
in this
initial 210 interim point there have been no
serious safety concerns that required the DSMB to be
notified.
Further
to the DSMB review and recommendations on each
interim
analysis periods, the Company aims to approach
the
FDA to obtain
agreement
on
filing
an
Emergency Use Authorization ("EUA") for
Bucillamine
to
treat mild to moderate
COVID-19.
"With
our funding completed we are
adding
more clinical sites to meet our
enrollment goals and
be in a
position to meet with the FDA to determine the best path forward
for EUA approval,"
said
Michael Frank, CEO of Revive. "We are committed to
achieving
our
mission in making Bucillamine
the
first orally administered drug to obtain FDA approval
and EUA
to
treat
mild to moderate COVID-19."
About
the Phase 3 Clinical Trial (ClinicalTrials.gov
Identifier: NCT04504734)
The
Phase 3 confirmatory clinical trial titled, "A Multi-Center,
Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine
in Patients with Mild-Moderate COVID-19", will enroll up to 1,000
patients that will be randomized to
either
Bucillamine
or placebo
for up
to 14 days. The primary objective is to compare the frequency of
hospitalization or death in patients with mild-moderate COVID-19
receiving Bucillamine with those receiving placebo. The primary
endpoint is the proportion of patients meeting a composite endpoint
of hospitalization or death from the time of the first dose through
Day 28 following randomization. Efficacy will be assessed by
comparing clinical
outcomes (death or hospitalization), disease severity using the
8-category NIAID COVID ordinal scale, supplemental oxygen use, and
progression of COVID-19
between patients receiving standard-of-care plus Bucillamine and
patients receiving standard-of-care plus placebo. Safety will be
assessed by reported pre-treatment adverse events and
treatment-emergent adverse events (including serious adverse events
and adverse events of special interest), laboratory values
(hematology and serum chemistry), vital signs (heart rate,
respiratory rate, and temperature), and peripheral oxygen
saturation.
The
Company is not making any express or implied claims that its
product has the ability to eliminate or cure COVID-19 (SARS-2
Coronavirus) at this time.
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
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.