Revive Therapeutics Provides
Update on Phase 3 Clinical Trial for Bucillamine in
COVID-19
TORONTO, Canada -- April 12, 2022 -- InvestorsHub NewsWire --
Revive Therapeutics Ltd. ("Revive" or the "Company") (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences
company focused on the research and development of therapeutics for
medical needs and rare disorders, is pleased to
provide an update on
the Company's U.S. Food & Drug Administration ("FDA") Phase 3
clinical trial (the "Study") (NCT04504734)
to evaluate the safety and
efficacy of Bucillamine, an oral drug with anti-inflammatory and
antiviral properties, in patients with mild to moderate
COVID-19.
The Data Safety and
Monitoring Board ("DSMB") are scheduled to meet this quarter to
evaluate the current clinical and safety data to either make
recommendations on the Study or advise on potentially halting the
Study early due to positive efficacy based on other clinical
outcomes evaluated such as the rate of sustained clinical
resolution of symptoms of COVID-19. The Company believes that with
the Omicron variant, including the BA.2 variant, being the dominate
strain over the Delta variant and COVID-19 hospitalizations in the
U.S. in decline, there is an urgent unmet need to treat symptom
resolutions in addition to preventing hospitalizations. The Company
has made efforts in determining the appropriate revised primary and
secondary clinical endpoints for FDA consideration for potential
Emergency Use Authorization. In parallel, the Company will continue
enrollment activities in the U.S. and Turkey and is still targeting
Q2-2022 to meet the enrollment goals.
"With COVID-19 cases on the
rise and the need for alternative oral treatments that is relevant
to the current state of the disease, we believe that Bucillamine's
anti-inflammatory and antiviral properties offers an alternative
potential solution that is urgently needed globally to fight
COVID-19 and allow for people to improve their quality of life,"
said Michael Frank, CEO of Revive.
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
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, 2021, which has been filed on SEDAR and is available under
the Company's profile at www.sedar.com.