Revive
Therapeutics Announces Update on FDA Phase 3 Clinical Trial for
Bucillamine in COVID-19
TORONTO, September.
29,
2020 -- 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 ("U.S. FDA") Phase 3 clinical trial
to evaluate the safety and efficacy of Bucillamine in patients with
mild-moderate COVID-19.
The Company has selected
and finalized with
five clinical sites in Florida, Texas and California for enrollment
of patients in the Phase 3 clinical
study,
and is
finalizing agreements with an additional
ten
clinical sites in these states
including
Arizona and Ohio
where
patient enrollment should start
in October
within these other locations.
"We have made significant progress in advancing the Phase 3
clinical trial
since the FDA approval allowed
us to proceed with the
study,
and we are expanding on and engaging with clinical sites in high
prevalence COVID-19 infected states, which will
enable
us to meet our enrollment goals and expedite the potential FDA
approval and commercialization of
Bucillamine for
the
treatment of COVID-19," said Michael Frank, Revive's Chief
Executive Officer.
About the Phase 3 Clinical Trial
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 1:1:1 to receive Bucillamine 100
mg three times a day ("TID"), Bucillamine 200 mg TID or placebo TID
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.
An interim analysis will be performed by an Independent Data and
Safety Monitoring Board ("DSMB") after 210 patients have been
treated and followed up for 28 days after randomization.
The better performing Bucillamine dose at the interim analysis will
be selected and patients will
then be randomized 2:1 to the selected Bucillamine dose or placebo.
Additional interim analyses will be performed after 400, 600, and
800 patients have reached this same post-treatment
timepoint.
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.
Scientific Rationale of Bucillamine for COVID-19
Preclinical and clinical studies have demonstrated that reactive
oxygen species contribute to the destruction and programmed cell
death of pulmonary epithelial cells.1 N-acetyl-cysteine (NAC) has
been shown to significantly attenuate clinical symptoms in
respiratory viral infections in animals and humans, primarily via
donation of thiols to increase antioxidant activity of cellular
glutathione2,3,4,5. Bucillamine
(N-(mercapto-2-methylpropionyl)-l-cysteine) has a well-known safety
profile and is prescribed in the treatment of rheumatoid arthritis
in Japan and South Korea for over 30 years. Bucillamine, a cysteine
derivative with two thiol groups, has been shown to be 16 times
more potent as a thiol donor in vivo than NAC 6. The drug is
non-toxic with high cellular permeability. The basis of the
clinical study will analyze if Bucillamine has the potential, via
increasing glutathione activity and other anti-inflammatory
activity, to lessen the destructive consequences of SARS-CoV2
infection in the lungs and attenuate the clinical course of
COVID-19.
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 have reviewed or accept 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 Offering, including the
intended use of proceeds. 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, 2019, which has been filed on SEDAR and is available
under the Company's profile at
www.sedar.com.
References
1.
S Ye et al, Inhibition of Reactive Oxygen Species Production
Ameliorates Inflammation Induced by Influenza A Viruses via
Upregulation of SOCS1 and SOCS3.,
American Society for Microbiology. 2015
Mar;89(5):2672-2683).
2.
L. Carati
et
al, Attenuation of influenza-like symptomatology and improvement of
cell-mediated immunity with long-term N-acetylcysteine
treatment.,
Eur Respir J. 1997
Jul;10(7):1535-41).
3.
M Mata et al, N-acetyl-L-cysteine (NAC) inhibit mucin synthesis and
pro-inflammatory mediators in alveolar type II epithelial cells
infected with influenza virus A and B and with respiratory
syncytial virus (RSV).,
Biochem
Pharmacol.
2011
Sep;82(5):548-55.
4.
D Ungheri
et
al, Protective effect of n-acetylcysteine in a model of influenza
infection in mice.,
Int J
Immunopathol
Pharmacol.
2000
Sep-Dec;13(3):123-128.
5.
RH Zhang et al, N-acetyl-l-cystine (NAC) protects against H9N2
swine influenza virus-induced acute lung injury.,
Int
Immunopharmacol.
2014
Sep;22(1):1-8).
6.
LD Horwitz, Bucillamine: a potent thiol donor with multiple
clinical applications,
Cardiovasc Drug Rev. 2003
Summer;21(2):77-90).
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