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 the Company’s Phase 3
clinical trial protocol to evaluate the safety and efficacy of
Bucillamine in patients with mild-moderate COVID-19 received
approval from the independent Institutional Review Board ("IRB") at
Advarra, a premier IRB services company in North America.
“With the IRB approval
of the Phase 3 study protocol for COVID-19, we can recruit U.S.
clinical sites efficiently, allowing us to move forward with
providing Bucillamine to patients under our IND that was approved
by the FDA last month,” said Michael Frank, Revive’s Chief
Executive Officer.
An IRB operates under FDA regulations and is an
FDA registered constituted group that has been formally designated
to review and monitor biomedical research involving human subjects.
In accordance with FDA regulations, an IRB has the authority to
approve, require modifications (to secure approval), or disapprove
research. The purpose of IRB review is to assure, both in advance
and by periodic review, that appropriate steps are taken to protect
the rights and welfare of humans participating as subjects in the
research. To accomplish this purpose, IRBs use a group process to
review research protocols and related materials (e.g., informed
consent documents and investigator brochures) to ensure the
protection of the rights and welfare of human subjects of
research.
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 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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