Revive Therapeutics is set to submit a revised protocol to the US Food and Drug Administration (FDA) with a new primary efficacy endpoint for its Phase III clinical trial of oral drug Bucillamine for mild to moderate Covid-19.
The trial will assess the safety and efficacy of Bucillamine in these patients.
Bucillamine is said to have anti-inflammatory, as well as antiviral properties.
Following the recent submission of the modified protocol of the trial, the company was in talks with the FDA to submit an updated protocol with a new primary efficacy endpoint.
This endpoint is intended to evaluate the variation in the proportion of trial subjects with a minimum of two clinical improvements in Covid-19 symptoms at day 14 against baseline between Bucillamine versus a placebo.
Clinical outcome (mortality or hospital admission), the time to the polymerase chain reaction resolution, severity of the disease, usage of supplemental oxygen, and Covid-19 progression may be included as additional secondary endpoints of the trial.
Revive plans to file the revised protocol in the coming week.
Once the regulatory agency approves the revised protocol, the trial’s Data Safety Monitoring Board (DSMB) will evaluate the concluded Post-Dose selection data of nearly 500 participants in relation to the new primary endpoint.
If a trend towards attaining statistical significance is found, the board may recommend progressing the trial.
The trial could be halted early due to positive efficacy demonstrating statistical significance, or if it fails to show a trend towards meeting statistical significance.
Irrespective of the outcome, the company plans to request a meeting with the FDA to agree on a proposed roadmap for potential regulatory approval.
In August 2020, the company announced plans to extend the Phase III trial of Bucillamine as a potential therapy for mild to moderate Covid-19 in Asia-Pacific Countries and Canada.