- Revive Therapeutics (RVV) has filed an amended protocol to the U.S. Food & Drug Administration for the company’s Phase 3 clinical trial
- The trial evaluates the safety and efficacy of Bucillamine in patients with mild to moderate COVID-19
- Revive has now submitted to the FDA a revised protocol for further discussion and agreement addressing a new primary efficacy endpoint
- If the FDA accepts the amended protocol, the Data Safety Monitoring Board will review the completed data under the new protocol’s primary efficacy endpoint
- Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders
- Revive Therapeutics Ltd. (RVV) opened trading at C$0.355
Revive Therapeutics (RVV) has filed an amended protocol to the U.S. Food & Drug Administration for the company’s Phase 3 clinical trial.
The trial evaluates the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19.
Revive has now submitted to the FDA a revised protocol for further discussion and agreement addressing a new primary efficacy endpoint, specifically, the time to resolution from COVID-19 via the polymerase chain reaction (“PCR”) test and secondary endpoints, including:
- Evaluating time to clinical improvement
- Comparing the frequency of hospitalization or death and disease course in patients with mild-moderate COVID-19 receiving Bucillamine therapy with those receiving a placebo.
These proposed endpoints address the shift in COVID-19 clinical outcomes observed over the course of the pandemic and may have more meaningful study endpoints for the FDA to consider for regulatory approval.
Should the FDA accept the amended protocol, the Data Safety Monitoring Board will review the completed Post-Dose selection data under the new protocol’s primary efficacy endpoint and may make a recommendation on continuing the study or advise on halting the study early due to positive efficacy showing statistical significance. In this case, Revive would proceed to seek regulatory approval from the FDA and other international health regulatory agencies.
Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders.
Revive Therapeutics Ltd. (RVV) opened trading at C$0.355.