Revive Therapeutics Provides Update on FDA Phase 3 Clinical Trial for Bucillamine in COVID-19
TORONTO, Oct. 26, 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 an update on the Company’s U.S. Food & Drug Administration (“U.S. FDA”) Phase 3 clinical trial (the “Study”) to
evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19. The Company has committed to ten clinical sites across Florida, Texas, Nevada, Arizona and California, and
it is estimated that over 200 patients will have completed the Study for the interim analysis by the end of December 2020. The interim analysis will determine the better performing Bucillamine dose
arm for the remainder of the trial and future complementary studies evaluating it in more severe cases, thus making Bucillamine a potential treatment option.
“We are one of a few life sciences companies evaluating an investigational drug in a Phase 3 clinical trial for COVID-19 and with the rising prevalence of cases throughout the U.S., we are confident that our targets will be achieved to support the potential FDA approval and commercialization of Bucillamine for the treatment of the virus,” said Michael Frank, Revive’s Chief Executive Officer.
The recent publication of the potential of N-acetyl-cysteine (“NAC”) in the treatment of COVID-191 serves as further validation for Bucillamine. 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.
In comparison, Bucillamine, with its well-established safety record in over 30 years of use in the treatment of rheumatoid arthritis, has been shown to be 16 times more potent as a thiol donor in vivo than NAC. Bucillamine also has the potential, via increasing glutathione activity and other antioxidant and anti-inflammatory activities,2 to lessen the destructive consequences of more advanced SARS CoV2 infections, and attenuate the clinical course of severe COVID-19.
About the Phase 3 Clinical Trial
The Phase 3 confirmatory clinical trial 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.