Revive Therapeutics Provides Update
on Phase 3 Clinical Trial for Bucillamine in COVID-19
-
701
subjects dosed to date
-
Initiating
enrollment activities in Turkey as part of its clinical
diversification plans to support global regulatory
approvals
-
On-track
to complete enrollment in Q1-2022 and FDA submission
thereafter
-
Commencing
regulatory package activities for submission to international
regulatory authorities for drug approvals
TORONTO, Canada -- January 19, 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.
A total of 701 subjects have been
dosed to date in the Study. The Company, in collaboration with
Delta Health, has initiated the enrollment activities in Turkey at
MLP Care, the largest hospital group in Turkey, and Istinye
University with access to 30 research sites and over 6000
in-patient hospital beds.
The Study's expansion into Turkey
complements the Company's global commercialization plan for
Bucillamine as a potential treatment for mild to moderate COVID-19.
As previously reported, in light of Phase 3 clinical studies and
FDA approvals of oral antiviral treatments by Pfizer and Merck, it
was evident that to improve the Study's outcome, a diversified
patient population from different countries is important to support
future global regulatory submissions. In addition, a diversified
subject population supports ongoing discussions with pharmaceutical
companies in Turkey and international markets.
The Company is on-track to complete
study enrollment in Q1-2022. Also, the Company is preparing its
regulatory package for submission to the FDA and international
regulatory authorities for drug approvals thereafter.
Michael Frank, CEO of the Company
commented, "We are now in the final stages in our Phase 3 study and
we are focused on completing enrollment, preparing the regulatory
packages for the FDA and international health authorities, and
negotiating manufacturing and marketing agreements with
pharmaceutical companies for commercialization."
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.