Revive Therapeutics Ltd (CSE:RVV, OTCQB:RVVTF) announced that the Independent Data and Safety Monitoring Board (DSMB) continues to support its Phase 3 clinical trials to evaluate the efficacy and safety of Bucilllamine in patients with mild or moderate coronavirus (COVID-19).
The Toronto-based company said that DSMB — an independent group of experts looking into accumulated study data for participant safety, study conduct, and progress — supported the study on grounds that there were no serious adverse events or safety concerns at the last meeting.
“As we move forward in our Phase 3 study in COVID-19 with the aim to seek Emergency Use Authorization (EUA) approval from the Food and Drug Administration (FDA) for Bucillamine in the treatment of mild to moderate COVID-19, we are also cognizant of the rapidly changing landscape of COVID-19 specifically with the Delta variant becoming widespread,” said Michael Frank, CEO of the Revive Therapeutics.
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He said that adding viral load testing to patients in the study, along with support in the research of the potential utility of thiol-based drugs, like Bucillamine in the Delta variant of COVID-19, shows confidence in the drug’s potential as a safe and effective oral treatment for mild to moderate COVID-19.
The final interim analysis, involving 800 completed patients, will be submitted to DSMB for review and recommendations on whether to continue, stop, or change the study. It is expected to be held in the final quarter of 2021.
The study, titled ‘Thiol-based drugs decrease binding of SARS-CoV-2 spike protein to its receptor and inhibit SARS-CoV-2 cell entry’, is a randomized, double-blinded, placebo-controlled trial. The research aims to decrease the binding of SARS-CoV-2 spike protein to its receptor, decrease the entry efficiency of SARS-CoV-2 spike pseudotyped virus, and inhibit SARS-CoV-2 live virus infection.
Revive supported this research under its sponsored agreement with the University of California, San Francisco in the laboratory of John Fahy to explore the utility of thiol-based drugs, including Bucillamine, against the Delta variant of COVID-19. Research results will be published shortly.
The company has engaged 46 clinical sites in 14 states including Alabama, Arkansas, California, Florida, Georgia, Illinois, Michigan, Nevada, New York, North Carolina, Ohio, South Carolina, Tennessee, and Texas.
Revive is hoping to secure a commercial supply of at least 5 billion Bucillamine tablets to potentially treat at least 50 million people globally for 2022.
“We recognize the market opportunity for Bucillamine and we are in discussions with our manufacturing partners to ensure that billions of Bucillamine tablets can be made available in 2022 to support our future commercialization partners and the millions of people globally,” Frank said.
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