Revive Therapeutics Announces IRB
Approval of US Expanded Access Treatment Program (Compassionate
Use) for Bucillamine in COVID-19
TORONTO, Canada -- September 16, 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 that the Company’s expanded
access protocol (“EAP”) for compassionate use of Bucillamine in the
treatment of COVID-19 received approval from the independent
Institutional Review Board (“IRB”). The EAP for compassionate use
is a multi-center, open label study of Bucillamine in hospitalized
patients with severe COVID-19 and is being done to complement the
Company’s Phase 3 COVID-19 study in the U.S. Revive expects
to have patients enrolled in the United States this month.
“With the IRB approval of the expanded access
protocol by Advarra, a premier IRB services company in North
America, hospitalized patients with severe COVID-19 may access
Bucillamine under the FDA compassionate use program under medical
supervision by their physician,” said Michael Frank, Revive’s Chief
Executive Officer. “The EAP serves as an option for patients that
are not eligible for inclusion criteria in our Phase 3 clinical
study in COVID-19 and the resulting data from the EAP will be
valuable in supporting our clinical development of
Bucillamine.”
The EAP for compassionate use provides
physicians with access to Bucillamine under Revive’s existing
Investigational New Drug (“IND”) application for COVID-19.
According to the FDA, expanded access is a potential pathway for a
patient with an immediately life-threatening condition or serious
disease or condition to gain access to an investigational medical
product for treatment outside of clinical trials when no comparable
or satisfactory alternative therapy options are available.
About the Expanded Access Study
The expanded access study is titled,
“Multi-Center, Open-Label, Expanded Access Study of Bucillamine in
Hospitalized Patients with Severe COVID-19
(EA-ARISE)”. Patients will receive
Bucillamine 200 mg orally, 3 times a day (TID), for up to 14 days.
The objective is to monitor the safety and efficacy of Bucillamine
(600 mg/day) and any clinical symptoms when administered up to 14
days in hospitalized patients with severe COVID-19. Following
completion of the treatment course, follow up safety assessments
will be performed by a study nurse 14 and 42 days following the end
of treatment.
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-CoV-2
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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