Phase III trial of bucillamine under analysis and setting new end points in COVID-19
Revive Therapeutics has provided an update on the company’s FDA Phase III clinical trial (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
The Company has unblinded the pre-dose selection data to potentially support the amended Study protocol with the new primary efficacy endpoints. The assigned unblinded statistician team is currently analyzing the data and the company aims to submit the amended Study protocol to the FDA shortly thereafter.
The proposed new primary efficacy endpoints may include the rate of sustained clinical resolution of symptoms of COVID-19, which 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. 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.
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