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 that following the U.S. Food
& Drug Administration (“U.S. FDA”) approval to proceed with the
Company’s Phase 3 clinical trial to evaluate the safety and
efficacy of Bucillamine in patients with mild-moderate COVID-19,
the Company is finalizing agreements and aligning resources to
initiate the Phase 3 clinical trial in September.
“With the FDA approval of the Phase 3 clinical
study to evaluate Bucillamine in the treatment of patients with
mild-moderate COVID-19, our team and partners are working
diligently to align our resources and expertise that will
fast-track the Phase 3 study,” said Michael Frank, Revive’s Chief
Executive Officer.
Revive expects to engage up to 10 clinical trial
sites in the U.S. and open the Phase 3 clinical trial for patient
screening in Q3-2020. The Company is finalizing vendor
agreements in the project management, medical monitoring, data
management and clinical packaging for the trials. In
addition, Revive and its clinical trial partners will be evaluating
potential U.S. clinical sites and clinical investigators in
major COVID-19 affected U.S. states, such as Florida, California,
Arizona and Texas.
About the Phase 3 Confirmatory Clinical
Study
The Phase 3 confirmatory clinical study 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 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 first dose through Day 28
following randomization. Efficacy will be assessed by
comparison of clinical outcome (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 a total of 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 FrankChief Executive OfficerRevive
Therapeutics Ltd.Tel: 1-888-901-0036Email:
mfrank@revivethera.comWebsite:
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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