Revive Therapeutics Ltd (CSE:RVV, OTCQB:RVVTF) has announced that the US Food & Drug Administration (FDA) accepted the company’s Data Access Plan (DAP) submission for a Phase 3 trial of Bucillamine in patients with Covid-19.
The company previously received positive comments from the FDA on its request to determine and agree on new primary efficacy endpoints for the study. Now that the DAP submission has been accepted, the company will unblind the pre-dose selection data to potentially support the amended study protocol with the new endpoints.
The proposed new primary efficacy endpoints may include the rate of sustained clinical resolution of symptoms of Covid-19, which the company says addresses the shift in clinical outcomes observed over the course of the pandemic. The hope is to have more meaningful study endpoints for the FDA to consider for potential Emergency Use Authorization.
READ: Revive Therapeutics submits data access plan for Bucillamine in coronavirus clinical trial to FDA
Revive believes that with the Omicron variant, including the BA.2 variant, being the dominant strain over the Delta variant, there is an “urgent 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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