Revive Therapeutics Ltd (CSE:RVV, OTCQB:RVVTF) has announced that the U.S. Food & Drug Administration (FDA) has accepted the company’s Data Access Plan (DAP) submission for a Phase 3 trial bucillamine in patients with Covid-19.

The company previously received positive feedback from the FDA on its application to determine and agree to new primary efficacy endpoints for the study. Now that the DAP submission has been accepted, the company will disclose pre-dose screening data to eventually support the modified study protocol with the new endpoints.

Proposed new primary efficacy endpoints may include the rate of sustained clinical resolution of Covid-19 symptoms, which the company says responds to changing clinical outcomes seen during the pandemic. The hope is to have more meaningful study parameters for the FDA to consider for possible emergency use authorization.

READ: Revive Therapeutics submits data access plan to FDA for bucillamine in coronavirus clinical trial

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 resolution in addition to preventing hospitalizations.”

Revive Therapeutics focuses on the research and development of therapies for infectious diseases and rare diseases and aims to take advantage of several regulatory incentives granted by the FDA, such as Orphan Drug, Fast Track, Breakthrough Therapy and rare pediatric disease.

Contact Andrew Kessel at [email protected]

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