Revive Therapeutics Ltd (CSE:RVV) (OTCMKTS:RVVTF) (FRA:31R) announced Wednesday that the company is on pace to meet the enrollment goals for its Phase 3 trial of bucillamine in mild-to-moderate cases of the coronavirus.
There are currently nine clinical sites participating in the study, with an additional six more clinical sites joining in January to satisfy the overall enrollment goal of up to 1,000 patients. Hitting enrollment goals allows the independent Data and Safety Monitoring Board (DSMB) to review safety and efficacy data from the first 210 patients, as part of an interim analysis of patients treated and followed up for 28 days after randomization.
Following the DSMB review, the company plans to file for an Emergency Use Authorization of Bucillamine for mild-to-moderate COVID-19 with the FDA. In November, the FDA granted two such EUAs for coronavirus treatments.
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“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,” CEO Michael Frank said in a statement.
The trial, titled, “A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients with Mild-Moderate COVID-19,” sees patients randomized 1:1:1 to receive bucillamine 100 mg three times a day (TID), bucillamine 200 mg TID or placebo TID for up to 14 days.
After 210 patients, the DSMB interim analysis will determine the better performing bucillamine dose arm for the remainder of the trial and future complementary studies of more severe cases.
Revive’s clinical safety team has actively monitored the ongoing interim data of patients and found there have been no safety concerns and no severe adverse events during the interim analysis enrollment period, the company said. In the event of any concerns, the DSMB would be notified to determine any risks and provide its recommendations.
The company also pointed to a recent study from the University of California San Francisco that showed that thiol-based drugs, like Bucillamine, decrease the binding of SARS-CoV-2 spike protein to its receptor, decrease the entry efficiency of SARS-CoV-2 spike pseudo-typed virus and inhibit SARS-CoV-2 live virus infection.
The findings uncovered a vulnerability of SARS-CoV-2 to thiol-based drugs and provide rationale to test thiol-based drugs as novel treatments for 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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