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 (“FDA”) Phase 3 clinical trial (the “Study”) to evaluate the safety and efficacy of Bucillamine in patients with mild to moderate COVID-19.
The Company currently has partnered with 14 clinical sites in six states including California, Florida, Illinois, Nevada, North Carolina and Texas and is now expanding to up to 50 clinical sites within the current states and in COVID-19 hot spot states such as Massachusetts, Michigan, New Jersey, New York, Pennsylvania, and South Carolina. The Company is on track to meet its planned enrollment goal for the Study in Q2-2021.
To date, there have been no serious adverse events or safety concerns that required the Independent Data and Safety Monitoring Board (“DSMB”) to be notified or take action on.
The Study is a randomized, double-blind, placebo-controlled trial and the safety and efficacy data at each interim analysis timepoint at 210, 400, 600 and 800 completed patients are only made available to the 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.
The Company has recently approached the FDA to obtain agreement on the potential for filing an Emergency Use Authorization (“EUA”) application, while the Study is ongoing, so as to receive EUA approval prior to the completion of the Study.
“We are making good progress both on enrollment and expansion of clinical sites in hot spot areas in the U.S. and we are positioned well to explore strategic initiatives in completing the Phase 3 study as well as seeking a path forward for EUA approval from the FDA,” said Michael Frank, CEO of Revive.
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 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 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. 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.
