DSMB supports continuation of Phase III trial of bucillamine in COVID-19.
The study is a randomized, double-blinded, placebo-controlled trial and the safety and efficacy data at each interim analysis timepoint, in which the final interim analysis will be at 800 completed patients, are only made available to the Independent Data and Safety Monitoring Board for review and recommendations on continuation, stopping or changes to the conduct of the study.
The DSMB supported continuation of the study in its last meeting as there was no serious adverse events or safety concerns reported and it is expected that the final interim analysis meeting, which will take place at 800 completed patients to be held in Q4-2021. The Company expects to eventually file an Emergency Use Authorization with the FDA in the event that the blinded results provide evidence to the DSMB’s final review to recommend to pursue EUA for Bucillamine to treat mild to moderate COVID-19.
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