TORONTO, Aug. 05, 2020 (GLOBE 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 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
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.
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