- Revive Therapeutics Ltd. (RVV) advances its U.S. Food and Drug Administration Phase 3 clinical trial for its COVID-19 therapy drug
- The goal of the trial is to evaluate the safety and efficacy of Bucillamine
- the FDA has accepted a new data plan to unblind the pre-dose selection data
- Proposed new trial results may include the rate of sustained clinical resolution of symptoms of COVID-19
- Revive Therapeutics Ltd. (RVV) is up 11.25 per cent and is trading at $0.44 per share as of 1:06 p.m. ET
Revive Therapeutics (RVV) has announced an update to its U.S. Food and Drug Administration (FDA) Phase 3 clinical trial for its COVID-19 therapy drug.
The goal of the trial is 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.
Following recent positive FDA comments, Revive stated the FDA has accepted its data plan to unblind the pre-dose selection data. Revive stated it will move on to this next step to potentially support the revised study protocol with the new primary efficacy endpoints.
The proposed efficacy results 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.
Revive believes that with the Omicron variant being the dominant strain, there is still a need to treat symptom resolutions in addition to preventing hospitalizations.
The company has issued a notice to say that it is not making any express or implied claims that its product can eliminate or cure COVID-19 at this time.
Revive Therapeutics Ltd. (RVV) is up 11.25 per cent and is trading at $0.44 per share as of 1:06 p.m. ET.