Revive Therapeutics Ltd. (RVV:TSX.V; RVVTF:OTCMKTS) announced in a news release it is on track to achieve the required milestone in its Phase 3 clinical trial of Bucillamine in patients with mild to moderate COVID-19 for a safety and efficacy data review by the Independent Data and Safety Monitoring Board (DSMB).
After 210 patients are treated and followed for 28 days post randomization, the board will conduct its review, part of the interim analysis. At that time, of the two Bucillamine doses being administered, the one with the best results will be chosen with which to move forward.
Patients then will be randomized on a 2-to-1 basis for that selected Bucillamine dose or for placebo. Subsequently, additional interim analyses will be done after 400, 600 and 800 study participants have reached the end of their 28-day follow-up period.
Currently, nine clinical sites are participating in the trial. Six more are slated to join in January 2021, which should take the total enrollment to the goal of up to 1,000 patients.
Revive noted that it has been monitoring safety throughout the study, and no safety concerns or serious adverse events have arisen.
"Further to the DSMB review and recommendations on the interim analysis periods, the Company aims to file for an Emergency Use Authorization (“EUA”) of Bucillamine for mild to moderate COVID-19 with the FDA," the company stated.
In the release, Revive noted that a recently published study out of the University of San Francisco, California shows that thiol-based drugs like Bucillamine hamper the binding of the SARS-CoV-2 spike protein to its receptor. In doing so, the therapeutics decrease the virus' ability to make cell entry and inhibit a resulting infection.
"We are pleased with the progress we have made to date in our Phase 3 clinical trial with the potential for Bucillamine to become the first orally administered drug to obtain emergency use access from the FDA and also potentially providing another therapeutic option for healthcare professionals to use in treating mild to moderate COVID-19," Revive CEO Michael Frank said in the release.
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