TORONTO, Feb. 26, 2021 — Revive Therapeutics Ltd. (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 (“FDA”) Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine in patients with mild to moderate COVID-19.
With its recent $23 million dollar financing, the Company plans to aggressively expand from 14 clinical sites to up to 50 clinical sites to meet the next enrollment goals for the Study in Q2-2021. The Study is a randomized, double-blinded, placebo-controlled trial and the safety and efficacy data analyzed at each interim analysis timepoint of 210, 400, 600 and 800 completed patients are only made available to the Independent Data and Safety Monitoring Board (“DSMB”) for review and recommendations on continuation, stopping or changes to the conduct of the Study. In the event of any serious safety concerns, the DSMB would be notified to determine any risks and provide its recommendations. To date, in this initial 210 interim point there have been no serious safety concerns that required the DSMB to be notified.
Further to the DSMB review and recommendations on each interim analysis periods, the Company aims to approach the FDA to obtain agreement on filing an Emergency Use Authorization (“EUA”) for Bucillamine to treat mild to moderate COVID-19.
With our funding completed we are adding more clinical sites to meet our enrollment goals and be in a position to meet with the FDA to determine the best path forward for EUA approval,” said Michael Frank, CEO of Revive. “We are committed to achieving our mission in making Bucillamine the first orally administered drug to obtain FDA approval and EUA to treat mild to moderate COVID-19.Michael Frank, CEO of Revive Therapeutics
About the Phase 3 Clinical Trial (ClinicalTrials.gov Identifier: NCT04504734)
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 to either Bucillamine or placebo 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 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 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.
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.
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