Revive Therapeutics Ltd (CSE:RVV, OTCQB:RVVTF) has provided investors with an update on its US Food and Drug Administration (FDA) Phase 3 clinical trial evaluating the safety and efficacy of bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19.
The company said it has unblinded the pre-dose selection data to potentially support an amended study protocol with new primary efficacy endpoints.
The proposed new primary efficacy endpoints may include the rate of sustained clinical resolution of symptoms of COVID-19, which the company said addresses the shift in COVID-19 clinical outcomes observed over the course of the pandemic to have more meaningful study endpoints for the FDA to consider the product for potential Emergency Use Authorization.
READ: Revive Therapeutics to unblind pre-dose selection data from Phase 3 Covid-19 trial of Bucillamine after FDA accepts Data Access Plan submission
Revive said the assigned unblinded statistician team was currently analyzing the data, with the company aiming to submit the amended study protocol to the FDA shortly thereafter.
“The company 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 said.
The company also noted that it was not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 at this time.
Revive Therapeutics is a life sciences company focused on the research and development of drugs for infectious diseases as well as central nervous system and inflammatory disorders.
Contact the author Emily Jarvie at emily.jarvie@proactiveinvestors.com
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