Revive Therapeutics Ltd (CSE:RVV) (OTCMKTS:RVVTF) (FRA:31R) said Friday it is planning to expand its Phase 3 clinical trial for Bucillamine in coronavirus (COVID-19) to 50 clinical sites.
The expansion is necessary to meet the study’s enrollment goals by the second quarter of the year, Revive said in a statement.
The Toronto-based life sciences company recently completed a C$23 million financing that will be used to fund the trial’s expansion, according to a statement.
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The randomized, double-blinded and placebo-controlled study is designed to evaluate the safety and efficacy of Bucillamine in patients with mild to moderate COVID-19.
Safety and efficacy data analyzed at each interim analysis timepoint of 210, 400, 600 and 800 completed patients are only made available to the Independent Data and Safety Monitoring Board (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, Revive said. There have been no serious safety concerns to date, the company added.
“With our funding completed, we are adding more clinical sites to meet our enrollment goals and be in a position to meet with the FDA to determine the best path forward for EUA approval,” said Michael Frank, CEO of Revive in a statement. “We are committed to achieving our mission in making Bucillamine the first orally administered drug to obtain FDA approval and EUA to treat mild to moderate COVID-19.”
Bucillamine, a cysteine derivative with two thiol groups, has been shown to be 16 times more potent as a thiol donor in vivo than N-acetyl-cysteine, the company said, and the drug has a well-known safety profile with more than 30 years of use as a treatment for rheumatoid arthritis in Japan and South Korea.
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