Revive Therapeutics Ltd (CSE:RVV, OTCQB:RVVTF) announced that it has submitted a request to the US Food & Drug Administration (FDA) to determine and agree on the potential new primary efficacy endpoints of the company’s Phase 3 clinical trial 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 researcher and developer of therapeutics for infectious diseases and rare disorders said the potential new primary efficacy endpoints include the rate of sustained clinical resolution of symptoms of COVID-19 that addresses the shift in COVID-19 clinical outcome observed over the course of the pandemic and, therefore, to have more meaningful study endpoints for the FDA to consider for potential Emergency Use Authorization (EUA).
Revive noted that it expects to obtain FDA agreement on the potential new primary efficacy endpoints in June 2022.
READ: Revive Therapeutics says in discussions with BARDA for potential development and commercial support for its COVID-19 oral drug, Bucillamine
The company added that the Data Safety and Monitoring Board are scheduled to meet in June 2022 to evaluate the interim clinical and safety data and may make a recommendation on continuing the study or advise on halting the study early due to positive efficacy based on other clinical outcomes such as the rate of sustained clinical resolution of symptoms of COVID-19.
Revive said it believes that with the Omicron variant, including the BA.2 variant, being the dominant strain over the Delta variant and COVID-19 hospitalizations in the US are in the decline, there is an urgent unmet need to treat symptom resolutions in addition to preventing hospitalizations.
Revive Therapeutics is focused on the research and development of therapeutics for infectious diseases and rare disorders and aims to take advantage of several regulatory incentives awarded by the FDA such as orphan drug, fast track, breakthrough therapy and rare pediatric disease designations.
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