Revive Therapeutics Provides Update on Phase 3 Clinical Trial for Bucillamine in COVID-19
- Expected to seek DSMB approval to proceed with EUA application to the FDA in Q2-2022
- Ongoing regulatory package activities for submission to international regulatory authorities for drug approvals
Revive Therapeutics Ltd.(CNSX: RVV, OTCMKTS: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to provide an update on the Company’s U.S. Food & Drug Administration (“FDA”) Phase 3 clinical trial (the “Study”) (NCT04504734) to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19.
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 6000 in-patient hospital beds. As previously mentioned, the Company has selected 13 clinical research sites to complete enrollment of the Study.
The Company now expects to complete full enrollment in Q2-2022 and to also submit the Study data for 800 subjects to the data safety monitoring board (“DSMB”) to seek DSMB approval to proceed with an Emergency Use Authorization (“EUA”) application to the Food and Drug Administration (“FDA”). The Company is preparing its regulatory package for submission to the FDA and international regulatory authorities for drug approvals.
With the emergence of BA.2 and other possible variants coming we feel there is still a vital need for a strong anti-inflammatory and anti-oxidant oral drug to coincide with other treatments.
Michael Frank, CEO of Revive Therapeutics
The Company is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time.
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