Revive Therapeutics Update Following U.S. FDA Approval of Phase 3 Clinical Trial for Bucillamine in COVID-19
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
“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
The Phase 3 confirmatory clinical study 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 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 first dose through Day 28 following randomization. Efficacy will be assessed by comparison of clinical outcome (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.