TORONTO, Canada -- April 23, 2020 --
InvestorsHub NewsWire -- Revive Therapeutics Ltd. (“Revive” or the
“Company”) (CSE: RVV), a specialty life sciences company focused
on the research and development of therapeutics for medical needs
and rare disorders, announced today that it has received positive
feedback from the U.S. Food and Drug Administration (“FDA”) in
response to the Company’s Pre-Investigational New Drug (“pre-IND”)
meeting that was announced on April 3, 2020. The FDA recommended
that the Company proceed directly into a Phase 3 confirmatory
clinical trial (“Phase 3 study”) to evaluate Bucillamine for the
treatment of patients with mild-moderate COVID-19 due to the
SARS-CoV-2 infection in order to ensure expeditious evaluation of
the safety and efficacy of Bucillamine.
“FDA’s support in advising Revive to move
directly into a Phase 3 confirmatory trial provides an
acknowledgment for the potential of Bucillamine in the treatment of
COVID-19,” said Michael Frank, Chief Executive Officer of Revive.
"Entering into a Phase 3 study is a major milestone for the
Company, and we are excited to unlock the full potential of
Bucillamine not only for this virus but also for other infectious
diseases that we will investigate in the future.”
In addition to its recommendation, the FDA
provided valuable guidance on study design and outcome measures for
the Phase 3 study. Importantly, the FDA agreed that Revive
could rely on its data included in its previous IND with
Bucillamine for gout to support the COVID-19 Phase 3 study and,
therefore, the Company did not have to perform any Phase 1 or Phase
2 clinical studies. The Company, along with its Contract
Research Organization, Pharm-Olam, LLC, and its clinical
development team led by Dr. Kelly McKee, Jr., MD, MPH, Chief
Scientific Officer consultant and Dr. Onesmo Mpanju, PhD,
Regulatory Affairs consultant, are actively incorporating the
pre-IND meeting guidance and preparing the package for submission
to the FDA. The Company expects to file the final IND within
the next 60 days and will plan to initiate the Phase 3 study
thereafter.
Scientific Rationale of Bucillamine
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 restore antioxidant and to reduce the activity of cellular
glutathione 2,3,4,5. 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 restoration of glutathione
activity and other anti-inflammatory activity, to lessen the
negative consequences of SARS-CoV2 infection in the lungs and to
help treat COVID-19 manifestations.
The Company is not making any express or implied
claims that its product has the ability to eliminate, cure or
contain the COVID-19 (or SARS-2 Coronavirus) at this
time.
The Company will continue to announce its Phase 3 study
initiatives as they unfold.
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 strains
including 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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