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 FrankChief Executive OfficerRevive Therapeutics Ltd.Tel:
1 888 901 0036Email:
mfrank@revivethera.comWebsite:
www.revivethera.comNeither 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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