In November 2020, the FDA also issued an EUA to permit the emergency use of bamlanivimab (manufacturer Eli Lilly) and the combination of casirivimab and imdevimab (manufacturer Regeneron) for the treatment of mild to moderate COVID-19. Revive Therapeutics Provides Update on FDA Phase 3 Clinical Trial for Bucillamine in COVID-19. Revive Therapeutics Ltd. a … Revive Therapeutics Ltd. ALL RIGHTS RESERVED. Preclinical and clinical studies have demonstrated that reactive oxygen species contribute to the destruction and programmed cell death of pulmonary epithelial cells.3 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 glutathione.4-7 In addition, it was found that thiol-based drugs decrease binding of SARS-CoV-2 spike protein to its receptor, decrease the entry efficiency of SARS-CoV-2 spike pseudotyped virus, and inhibit SARS-CoV-2 live virus infection.8 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. 3. H Ibrahim et al, Therapeutic blockade of inflammation in severe COVID-19 infection with intravenous N-acetylcysteine., Clinical Immunology. The drug is non-toxic with high cellular permeability. These statements relate to future events or future performance. The DSMB is independent from the Company, the investigators of the Study, or anyone involved in the clinical care of the Study subjects and oversees the safety of participating patients by reviewing the Study’s accumulating safety and efficacy data for Bucillamine. Scientific Rationale of Bucillamine for COVID-19. LD Horwitz, Bucillamine: a potent thiol donor with multiple clinical applications, Cardiovasc Drug Rev. Additional interim analyses will be performed after 400, 600, and 800 patients have reached this same post-treatment timepoint. (Forwards to SEDAR website). 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. The Company is on pace to meet its enrollment goals for the Independent Data and Safety Monitoring Board (“DSMB”) to review the safety and efficacy data from the 210 patients as part of the first interim analysis of patients treated and followed up for 28 days after randomization. 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. Revive Therapeutics Provides Update on FDA Phase 3 Clinical Trial for Bucillamine in COVID-19. FDA”) has approved the Company to proceed with a randomized, double-blind, placebo-controlled confirmatory Phase 3 clinical trial protocal to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19 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. Type: . With its recent acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in … :1535-41 ) Respir J in severe COVID-19 infection with intravenous N-acetylcysteine., Clinical Immunology any... Provide its recommendations michael FrankChief Executive OfficerRevive Therapeutics Ltd.Tel: 1 888 901 0036Email: mfrank revivethera.comWebsite!, and 800 patients have reached this same post-treatment timepoint uncertainties and,... 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