Revive Therapeutics Ltd (RVVTF)

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Revive Therapeutics Provides Update on Phase 3 Clinical Trial for Bucillamine in COVID-19
https://www.globenewswire.com/news-release/2022/10/06/2529697/0/en/Revive-Therapeutics-Provides-Update-on-Phase-3-Clinical-Trial-for-Bucillamine-in-COVID-19.html

TORONTO, Oct. 06, 2022 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, today announced 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.

Further to the Company’s recent submission of the Study’s amended protocol, the Company has been in communication with the FDA to submit a revised protocol with a new primary efficacy endpoint, specifically, assessing the difference in the proportion of participants with at least two clinical improvements in symptoms of COVID-19 at Day 14 compared with baseline between Bucillamine versus placebo. Additional secondary endpoints may include clinical outcome (death or hospitalization), the time to the polymerase chain reaction resolution, disease severity, supplemental oxygen use, and progression of COVID-19. The Company expects to submit the revised protocol next week. Should the FDA agree with the revised protocol, the Data Safety Monitoring Board (“DSMB”) will review the completed Post-Dose selection data of approximately 500 subjects in the context of the new primary endpoint. The DSMB may recommend continuing the Study if there is a trend toward achieving statistical significance, halting the Study early due to statistical significance likely not going to be met, or halting the Study early due to positive efficacy showing statistical significance. Regardless of the outcome, the Company would proceed to seek a meeting with the FDA to agree on a proposed plan for potential regulatory approval.

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.