In a news release, Revive Therapeutics Ltd. (RVV:TSX.V; RVVTF:OTCMKTS) announced that "it has submitted its Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 3 confirmatory study for Bucillamine as a potential treatment in COVID-19." The firm indicated that after the FDA grants permission for the IND to go forward, it plans to proceed with a randomized, double-blind, placebo-controlled study in Q3/20 of Bucillamine in patients with mild-moderate COVID-19.
Revive Therapeutics' CEO Michael Frank commented, "We are very pleased in achieving this major milestone of filing our IND for a Phase 3 confirmatory study to evaluate Bucillamine in the treatment of patients with mild-moderate COVID-19, which was based on the recommendation from the U.S. FDA from our pre-IND meeting earlier this year...We are preparing plans for initiating the Phase 3 study upon the IND becoming active by the U.S. FDA and we look forward to advancing Bucillamine as a potential new treatment option for patients with a confirmed diagnosis of COVID-19 globally."
The firm advised that the Phase 3 randomized clinical trial is designed to study Bucillamine in patients with mild-moderate COVID-19 and that the study will enroll up to 800 patients who will receive either a 100 mg or 200 mg dose of Bucillamine or a placebo for up to 14 days.
The company noted that the primary objective in the study will be to compare frequency of hospitalization and mortality in patients with mild-moderate COVID-19 receiving Bucillamine therapy compared to the controlled placebo group. "The primary endpoint is the proportion of patients with the following outcomes attributed to COVID-19 from time of the first dose through Day 28 following randomization: death, alive and hospitalized, and alive and not hospitalized."
The firm noted that an Independent Data and Safety Monitoring Board will perform an interim analysis after 210 patients have been treated and followed up for a total of 28 days after randomization. The company stated that the Bucillamine dosage level with the best achieved results will then be identified and then randomized 2:1 to the placebo as the trial progresses.
The company advised that "it 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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