Revive Therapeutics Ltd (CSE:RVV, OTCQB:RVVTF) has provided an update on the company’s US Food and Drug Administration (FDA) Phase 3 clinical trial (NCT04504734) to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild-to-moderate coronavirus (COVID-19.)
The Toronto-based life sciences company said it now expects to complete full enrollment in second-quarter 2022 and to also submit the study data for 800 subjects to the data safety monitoring board (DSMB) to seek its approval to proceed with an Emergency Use Authorization (EUA) application to the FDA.
Revive Therapeutics emphasized in its update that it is preparing its regulatory package for submission to the FDA and international regulatory authorities for drug approvals.
In collaboration with Delta Health, the study is targeting clinicals sites operated by MLP Care, the largest hospital group in Turkey, and Istinye University with access to 30 clinical research sites and over 6,000 in-patient hospital beds. The company has selected 13 clinical research sites to complete enrollment of the study.
"With the emergence of BA.2 (Omicron BA.2) and other possible variants coming we feel there is still a vital need for a strong anti-inflammatory and antioxidant oral drug to coincide with other treatments,” Revive Therapeutics CEO Michael Frank said in a statement.
Revive is focused on the research and development of therapeutics for infectious diseases and rare disorders.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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