Revive Therapeutics Ltd. (RVV:TSX.V; RVVTF:OTCMKTS) announced in a news release it met with Health Canada to discuss a Phase 3 clinical trial in Canada of Bucillamine as a therapeutic for mild to moderate COVID-19 infections.
"We were pleased with our discussions with Health Canada at the pre-CTA meeting which provided us with valuable guidance on the clinical study design and information that is required for the submission of the complete CTA package," Revive CEO Michael Frank said in the release.
"We are focused on advancing Bucillamine as a potential treatment for COVID-19, and the submission of our FDA IND application for our Phase 3 clinical study will form the foundation for our multinational clinical plans including Canada," Frank stated.
During the preclinical trial application meeting, the Ontario, Canada-based biopharmaceutical firm and Health Canada discussed the rationale for using Bucillamine, an anti-rheumatic agent, as a potential COVID-19 therapy, along with the drug's chemistry, clinical trial design, safety and manufacturing.
The federal health agency advised Revive on an ideal study design and on the clinical trial application requirements.
Revive intends to submit an investigational new drug application to the U.S. Food and Drug Administration this month for Bucillamine in this indication.
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