Revive Therapeutics Provides Update on FDA Phase 3 Clinical Trial for Bucillamine in COVID-19 with Planned Completion...Cont
February 26 2021 - 9:01AM
InvestorsHub NewsWire
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 (GlobeNewswire) -- 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 Q2-2021.
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.
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