Revive
Therapeutics Provides
Update on FDA
Phase
3 Clinical Trial
for Bucillamine
in COVID-19
TORONTO,
March
24,
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.
The
Company
currently
has
partnered
with 14
clinical
sites
in six
states including California, Florida, Illinois,
Nevada, North Carolina
and Texas and is now
expanding to up to
50 clinical sites within the current
states and in COVID-19 hot spot states
such
as Massachusetts,
Michigan, New Jersey, New York, Pennsylvania, and
South Carolina. The Company is on
track to meet
its
planned enrollment
goal
for the Study in
Q2-2021.
To
date, there have been no serious adverse
events or safety
concerns that
required the
Independent Data and Safety Monitoring Board ("DSMB")
to be
notified or take action
on.
The Study is
a
randomized, double-blind, placebo-controlled
trial and the safety and efficacy data at each
interim analysis
timepoint at
210,
400, 600 and 800
completed
patients
are only made available to the 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.
The Company has recently approached the FDA to obtain agreement on
the potential for filing an Emergency Use Authorization ("EUA")
application, while the Study is ongoing, so as to receive EUA
approval prior to the completion of the Study.
"We
are making good progress both on enrollment and expansion of
clinical sites in hot spot areas in the U.S. and we are
positioned well to
explore strategic initiatives in completing the Phase 3 study as
well as seeking a path
forward for EUA approval from the FDA,"
said
Michael Frank, CEO of Revive.
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
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 therapy 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 (high
dose and/or low dose) 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 independent
DSMB will actively monitor interim data for the ongoing safety of
patients and will recommend continuation, stopping or changes to
the conduct of the study based on the interim analysis
reports.
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
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.
